Zoliflodacin was developed as part of a public-private research and development (RCD) partnership between GARDP and Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., who was responsible for filing the New Drug Application (NDA) with the US Food and Drug Administration (FDA) and is the marketing authorization holder in the United States. Recognition for this much-needed new treatment for gonorrhoea comes at a time when antimicrobial resistance (AMR) is making the sexually transmitted infection increasingly difficult to treat.

Approved by the US FDA in December 2025 and subsequently by the Thailand FDA in June 2026, zoliflodacin is the first new antibiotic developed solely for gonorrhoea, and one of the first new treatments for this disease in decades. It is also the first to be developed using a novel not-for-profit approach to antibiotic RCD aimed at tackling the rise and spread of AMR.

“Being nominated for a Prix Galien award is a tremendous honour and recognition not only of zoliflodacin itself, but of the power of partnership in addressing some of the world’s most urgent public health challenges,” said Peter Beyer, Deputy Executive Director of GARDP. “At a time when antimicrobial resistance is outpacing antibiotic development, this achievement demonstrates that a public health-driven approach can deliver innovation while also working to ensure access for the people who need it most.”

An estimated 82 million new gonorrhoea infections occur globally every year. The bacterium that causes gonorrhoea has developed resistance to almost every antibiotic used against it, with resistance now emerging even to ceftriaxone, the last remaining recommended treatment. Without new treatment options, gonorrhoea risks becoming increasingly difficult, and in some cases impossible, to treat.

Zoliflodacin belongs to a new class of antibiotics known as spiropyrimidinetriones and works through a novel mechanism of action with activity against multidrug-resistant isolates of Neisseria gonorrhoeae, including isolates resistant to current antibiotics.

Zoliflodacin’s approval follows a pivotal phase 3 clinical trial, that was sponsored and led by GARDP, which met its primary objective when compared against the current global standard of care. The findings of this trial were published on 11 December 2025 in The Lancet. Also, in parallel microbiology studies, zoliflodacin has been shown to be active against all multidrug-resistant strains of N. gonorrhoeae tested, with no cross-resistance with other antibiotics.

The development of zoliflodacin also represents an important proof of concept for a new approach to antibiotic research and development. Unlike traditional commercial models, the GARDP partnership model is designed around public health need, combining innovation with plans for stewardship and access from the outset. GARDP has rights to support registration and access across more than three-quarters of countries worldwide, including all low-income countries and most middle-income countries.

The rapid approval of zoliflodacin in Thailand, just six months after its first approval in the United States, has already challenged the traditional model in which new antibiotics often take many years to reach low- and middle-income countries (LMICs).

“Zoliflodacin shows what is possible when governments, researchers, industry, funders and public health organizations work together around a shared objective,” said Pierre Daram, Associate Director of the STI Portfolio at GARDP. “But it is also a reminder that the fight against AMR is far from over. We need a sustainable pipeline of new antibiotics and a continued commitment to ensuring they are available and used appropriately around the world.”

GARDP is continuing to work with partners to expand access to zoliflodacin in its territories, pursue additional regulatory approvals, generate evidence to support its optimal use, and advance the next generation of medicines for drug-resistant infections.

About zoliflodacin

Zoliflodacin is a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea. It is the first new antibiotic developed solely for gonorrhoea and one of the first new treatments against gonorrhoea in decades.

About GARDP

GARDP (the Global Antibiotic Research C Development Partnership) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, GARDP develops and makes accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland.  www.gardp.org.

Media contact

Duncan Graham-Rowe, Senior Communications Advisor, dgrahamrowe@gardp.org

Source

• Thai FDA approves NUZOLVENCE® (zoliflodacin), a first-in-class, single-dose, oral antibiotic for uncomplicated urogenital gonorrhoea.
• Approval comes just six months after US FDA approval, making Thailand the second country to approve the drug.
• Sets a new benchmark for rapid access to innovative medicines through collaboration between GARDP and Dr. Reddy’s.

Bangkok (Thailand), Geneva (Switzerland) and Hyderabad (India), 27 July 2026 – The GARDP Foundation (known as GARDP) and Dr. Reddy’s Laboratories today announced that the Thai Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin), a first-in-class, single-dose, oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea. The approval follows a priority review submission led by Dr. Reddy’s Laboratories, with support from GARDP.

NUZOLVENCE® is indicated for the treatment of uncomplicated urogenital gonorrhoea due to Neisseria gonorrhoeae in adults and paediatric patients 12 years of age and older, weighing at least 35 kg. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Zoliflodacin was developed as part of a public-private research and development (R&D) partnership with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA). Innoviva Specialty Therapeutics is the marketing authorization holder in the United States. Zoliflodacin was submitted for priority review in Thailand in November 2025, a process led by the global pharmaceutical company, Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; together with its subsidiaries, known as “Dr. Reddy’s”), with support from GARDP.

The Thai FDA approval comes just six months after the drug was initially approved by the United States Food and Drug Administration (US FDA), making Thailand the second country to approve the new chemical entity (NCE). This sets a new benchmark for how quickly innovative treatments can reach low-and middle-income countries (LMICs) beyond initial high-income market approvals and marks a major milestone in efforts to expand rapid access to new antibiotics globally.  

The approval is particularly significant given the growing threat of antimicrobial resistance (AMR), which is making gonorrhoea increasingly difficult to treat with existing antibiotics. The Thai FDA has granted approval for NUZOLVENCE®, reflecting Thailand’s strong commitment to AMR as a national public health priority. With more than 82 million new gonorrhoea infections occurring globally each year, zoliflodacin offers much-needed hope for patients with this sexually transmitted infection (STI).

“As a global pharmaceutical company, Dr. Reddy’s purpose is to make innovative and affordable medicines accessible to patients worldwide,” said Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy’s. “The approval of zoliflodacin by the Thai FDA is a significant step forward in ensuring timely access to an innovative treatment for gonorrhoea, including infections caused by multidrug-resistant strains. It underscores a new paradigm for global health access – where patients in LMICs can benefit from breakthrough medicines within months of their first approval rather than waiting years. This milestone reflects the power of collaboration in advancing equitable and sustainable access to critical new therapies.”

The zoliflodacin approval follows a pivotal phase 3 clinical trial that was sponsored and led by GARDP and which met its primary objective when compared against the current global standard of care. The findings of this trial were published on 11 December 2025 in The Lancet. Supporting these clinical findings, in previous in vitro studies, zoliflodacin has also been shown to be active against all multidrug-resistant strains of N. gonorrhoeae tested, with no cross-resistance with other antibiotics. 

“This approval marks a turning point not only for the treatment of gonorrhoea, but for how new antibiotics can be made available to people globally,” said Peter Beyer, Deputy Executive Director of GARDP. “This is proof that our novel antibiotic R&D model works and demonstrates the important role that product development partnerships like GARDP play in ensuring that antibiotics with high public health value are able to progress even when the market remains unattractive. GARDP is now committed to supporting its partners in working towards making zoliflodacin available to patients in Thailand.”

The approval reflects the coordinated efforts of GARDP, Dr. Reddy’s Laboratories and its subsidiary, Aurigene Pharmaceutical Services Limited (APSL), in advancing zoliflodacin. APSL played an important role in supporting the product’s development, while Dr. Reddy’s led the regulatory submission strategy and engagement with the Thai FDA. Building on this approval, GARDP, Dr. Reddy’s and APSL will continue to work closely with healthcare stakeholders in Thailand to support commercialization, ensure reliable supply, and facilitate broad patient access to this important new treatment.

GARDP has the right to register and commercialize zoliflodacin in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. Entasis Therapeutics, Inc., the original license holder and an affiliate of Innoviva Specialty Therapeutics, retains the commercial rights for NUZOLVENCE® in the major markets, such as North America and the European Union. In addition to Thailand, GARDP is taking steps to obtain market authorization in South Africa. These countries were selected not only because they are important partners for GARDP, but also because they played a key role in the phase 3 trial.

GARDP’s work on zoliflodacin has been funded with support from the governments of Germany (BMFTR and BMG), UK (GAMRIF, part of DHSC, and DFID, which is now part of FCDO), the European Commission through its Health Emergency Preparedness and Response Authority (DG HERA), Japan (MHLW), the Netherlands (Ministries of VWS and BZ), Switzerland (FOPH), The Grand Duchy of Luxembourg, as well as the Canton of Geneva, South African Medical Research Council (SAMRC), and the Leo Model Foundation. This builds on initial work by AstraZeneca, who first identified the NCE that was to become zoliflodacin and on a critical phase 2 clinical trial sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).

About Dr Reddy’s

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait,’ we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

About GARDP

GARDP (the Global Antibiotic Research & Development Partnership) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, GARDP develops and makes accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland.  www.gardp.org.

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GENEVA – 8 June 2026 – Three non-profit R&D organizations—the Drugs for Neglected Diseases initiative (DNDi), the GARDP Foundation (known as GARDP), and Medicines for Malaria Venture (MMV)—have signed a cooperation agreement to explore how they can further pool their expertise and resources to strengthen the efficiency and coordination of their activities, with the ultimate goal of accelerating the development of life-saving treatments for patients who need them most. 

The areas to be explored will focus particularly on R&D. The three organizations—known as product development partnerships, or PDPs—will also strengthen joint policy advocacy and communications activities to raise awareness of their alternative, non-profit drug development model. 

Through this initiative, the three organizations aim to maximize the impact of limited global health R&D resources and show global leadership as calls to reform the global health architecture multiply. Equitable medical innovation, driven by patient needs, must be at the core of the future global health architecture, and economic incentives alone will not suffice to deliver the innovations or the equitable access patients urgently need. 

By speaking with one unified voice, DNDi, GARDP, and MMV reaffirm their commitment to work together and with partners across all regions to accelerate the delivery of effective, affordable, and life-saving medicines through this agreement. This commitment is critical in the current context of shrinking global health budgets, aid cuts, and threats to multilateralism. 

The need for medical innovation is greater than ever. In 2024, an estimated 282 million people contracted malaria, and 610,000 died from it. Nearly 5 million deaths a year are now associated with drug-resistant bacterial infections. More than one billion people are affected by neglected diseases each year. 

Recent health crises, such as the COVID-19 pandemic and the ongoing Ebola outbreak in Central Africa, are also stark reminders that many much-needed life-saving innovations, including therapeutics, do not exist—and when they do, they too often fail to reach the most vulnerable populations. 

Product development partnerships have demonstrated their ability to deliver life-saving health tools: since 2010, they have developed and delivered 79 new diagnostics, drugs and vaccines that have reached 2.4 billion people. PDPs have shown they can deliver comparable innovation outcomes more cost-effectively than traditional development models, particularly in areas of market failure. 

The agreement signed by DNDi, GARDP, and MMV sets a framework to build on existing collaborations. Since 2016, DNDi and GARDP have shared several operational and back-office support functions. The two organizations also established a joint Chemistry, Manufacturing, and Controls (CMC) platform to share their know-how in the design, development and scale-up of manufacturing processes of active pharmaceutical ingredients and drug products.  

This year, DNDi and MMV are planning to launch a joint regulatory science platform to shorten registration timelines, strengthen their regulatory strategies, and accelerate equitable access to medicines through collaboration and shared knowledge.  

‘The global health environment is changing fast, but patients’ unmet needs remain. We invite other non-profit research organizations committed to equitable access and leaving no patient behind to join our collective efforts with our partners GARDP and MMV. In a rapidly shifting environment, closer, smarter, more agile collaboration is essential to deliver life-saving health tools for millions in urgent need’ said Dr Luis Pizarro, Executive Director of DNDi. 

‘At a time of growing antimicrobial resistance and shrinking global health resources, collaboration is no longer optional — it is essential,’ said Dr Peter Beyer, Deputy Executive Director of GARDP. ‘This partnership brings together complementary expertise to accelerate the development of urgently needed treatments and to ensure they reach the patients who need them most. By working more closely with DNDi and MMV, we can strengthen our collective impact and help build a more coordinated and effective global R&D ecosystem.’  

‘Partnership and collaboration are essential to maximizing global health impact. By working more closely with DNDi and GARDP, we can accelerate patient–centred innovation and ensure that life–saving treatments reach those who need them most,’ said Dr Martin Fitchet, CEO of MMV.  

About DNDi 

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, parasitic worm diseases, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver 14 new treatments, saving millions of lives. dndi.org 

About GARDP 

GARDP (the Global Antibiotic Research & Development Partnership) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, GARDP develops and makes accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland.  www.gardp.org 

About MMV 

No one should die from malaria. Yet in 2024, more than a quarter of a billion people fell sick and over 600,000 lives were lost – most of them young children. We believe this is unacceptable. 

Founded in 1999, MMV is a not-for-profit product development partnership (PDP). We work “end-to-end” to discover, develop and deliver accessible and affordable medicines to treat, prevent and eliminate malaria. Starting where the need is greatest – with children and pregnant women – we collaborate equitably with partners across sectors and geographies, ensuring innovation reflects local realities and reaches those most at risk. 

It’s working. As of 2026, we have brought forward 19 medicines that have treated or protected more than 1.48 billion people worldwide. We cannot stop now. 

MMV is part of an ecosystem of partners determined to eliminate malaria. As a PDP, we bring the public and private sectors together to promote the equitable development of breakthrough solutions to help end malaria and advance health for all.  

For more information, visit www.mmv.org.  

Source

KfW, Germany’s Development Bank, to implement partnership, ensuring continuity in funding for early-stage antimicrobial resistance research and late-stage clinical development.

Lyon, 7 April 2026 – The European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA) announced today at the One Health Summit in Lyon a new €30 million EU4Health investment managed by KfW, Germany’s Development Bank, to Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research & Development Partnership (GARDP) to strengthen the global response to antimicrobial resistance (AMR).

AMR is a major threat to health, associated with more than 35,000 deaths annually in the European Union, and efficient medical countermeasures including vaccines, diagnostics, antibiotics and alternatives are lacking. Fostering development of new products to address AMR is essential to fighting AMR effectively.

The new partnership will support the work of CARB-X to accelerate early-stage antibacterial research and GARDP to advance late-stage clinical development projects as a holistic approach to innovation to ensure a comprehensive and sustainable pipeline for AMR medical countermeasures. The partnership builds on DG HERA’s prior work as outlined in the EU4Health work programme for 2025 to enhance health preparedness and resilience by reducing the burden of AMR-related morbidity and mortality and increasing development, innovation, and availability of AMR medical countermeasures.

KfW will implement the partnership, bringing extensive experience in managing international funding programmes and fostering public-private partnerships. It will also support coordination and knowledge dissemination activities, including the establishment of an Antimicrobial Drug Pipeline Coordination Forum to align stakeholders, maximize the impact of EU-funded AMR R&D activities, and accelerate access to medical countermeasures.

“With this action, the Commission, through its Health Emergency Preparedness and Response Authority (DG HERA), is reinforcing the EU’s preparedness by supporting end-to-end innovation for antibacterial products and other countermeasures against AMR,” said Hadja Lahbib, European Commissioner for Equality, Preparedness and Crisis Management. “By aligning innovation from early discovery to clinical validation, we can accelerate the development of these lifesaving products and ensure their availability. This approach tackles AMR and strengthens EU readiness for other emerging health threats, embodying our mission to build resilience and prepare for the next health crisis.”

DG HERA has made sustained investments to address AMR as it is one of the most pressing cross-border health threats for Europe and the world. By financing public-private partnerships that bridge early-stage innovation and clinical development, DG HERA ensures that promising medical countermeasures addressing AMR can advance efficiently from discovery to patient use, strengthening health security within the EU and globally.

“Germany is strongly committed to combating AMR,” said Matthias Hauer, Parliamentarian Secretary of State, German Federal Ministry of Research, Technology and Space. “AMR is a growing global challenge and only through joint public research funding, resilient partnerships and sustained investment can we protect public health in Europe and worldwide. The German Federal Ministry of Research, Technology and Space therefore supports international initiatives such as CARB-X and GARDP. We welcome the additional funding of CARB-X and GARDP by the European Commission’s DG HERA. By supporting CARB-X and GARDP and by implementing and managing the EU investment through KfW, Germany’s Development Bank, we are helping to secure the pipeline of new antibiotics and other medical countermeasures.”

“As the implementing partner, KfW is proud to support the EU response to AMR,” said Christiane Laibach, Member of the Board of KfW Banking Group. “By supporting the antimicrobial drug development pipeline coordination efforts, and working with trusted product development partnerships such as CARB-X and GARDP, we can de-risk innovation and ensure that lifesaving medical countermeasures against antimicrobial resistance are available and accessible globally, including by citizens across the EU, when they are most needed.”

Under this initiative, CARB-X will support early-stage research on novel antibiotics, vaccines, preventatives, and diagnostics, while GARDP will advance late-stage clinical development projects, including new antibiotic treatments for neonatal sepsis and drug-resistant serious bacterial infections.

“Europe’s investment is more than a boost for AMR innovation—it is a strategic commitment to both the health of citizens and resilient socioeconomic growth. By supporting early-stage R&D, the EU is helping ensure a steady flow of new vaccines, diagnostics, preventatives, and antibiotics that benefit patients, protect health systems, reduce future healthcare costs, and strengthen economic stability,” said Kevin Outterson, Executive Director of CARB-X. “This partnership with DG HERA, KfW, and GARDP reflects the EU’s global leadership and reinforces the simple truth: safeguarding antimicrobial effectiveness today is essential to sustaining prosperity and security for decades to come.”

“Through this partnership between DG HERA, KfW, CARB-X and GARDP, the European Union is showing true global leadership in tackling the growing threat of antimicrobial resistance,” said Dr Manica Balasegaram, GARDP’s Executive Director. “This support builds on DG HERA’s previous investment and allows us to develop new antibiotics that are effective against WHO priority pathogens, and ensure that they reach the people who need them most.”

Note to Editors

CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership accelerating early antibacterial innovation to address the rising threat of drug-resistant bacteria. Supported by a global consortium of governments and foundations, CARB-X supports innovative therapeutics, preventatives, and rapid diagnostics with comprehensive scientific and support and non-dilutive funding. CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Gates Foundation, Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the Novo Nordisk Foundation, Italy’s Ministry of Economy and Finance (MEF), Japan’s Ministry of Health, the European Commission’s DG Health Emergency Preparedness and Response Authority (DG HERA), and KfW Development Bank. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or its funders.

The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, GARDP develops and makes accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland.  www.gardp.org

The Health Emergency Preparedness and Response Authority (DG HERA), part of the European Commission, is responsible for ensuring the availability and accessibility of medical countermeasures needed to respond to cross-border health threats. It plays a central role in strengthening the EU’s preparedness and resilience against antimicrobial resistance and other health emergencies.

KfW is one of the world’s leading promotional banks and a key implementing partner of the German Federal Government. It finances and manages programmes that foster sustainable economic and social development and strengthen global health security, including through support for public–private partnerships and innovation in medical countermeasures.

Media contacts

GARDP – press@gardp.org

CARB-X – carbxpr@bu.edu

KfW  – presse@kfw.de

DG HERA (European Commission) – mailto:hera-press@ec.europa.eu; HERA-COMMUNICATION@ec.europa.eu

Source

Geneva/Labège, 23 March 2026 — The French biotech company Antabio and the GARDP Foundation (known as GARDP) today announced a joint effort to accelerate crucial early-stage antibiotic discovery, responding to a steep rise in drug-resistant infections worldwide and a dwindling supply of innovative new treatments.

Drug-resistant infections are estimated to kill more than one million people each year, yet the development of novel antibiotics remains critically low. Fewer than one in five antibiotics in today’s clinical pipeline show true innovation such as a new chemical class, a new mode of action or no cross-resistance.

Despite being one of the most dynamic areas of antibiotic innovation, the “discovery” phase is often neglected in the drug research and development cycle, especially by commercial investors. This stage is increasingly important, however, since it is when scientists can uncover new chemical classes and mechanisms active against drug-resistant pathogens – targeting bacterial survival mechanisms that current treatments fail to reach.

“Discovery research is a particularly fragile part of the antibiotic pipeline, and yet it’s where the future of new therapeutics begins,” said Dr Alan Hennessy, Head of Discovery at GARDP. “By combining GARDP and Antabio’s complementary resources and expertise, we can move promising antibacterial candidates forward faster and give them the best chance of becoming the innovative medicines that people so badly need.”

As part of the collaboration, the partners will advance selected “Hit-to-lead” projects, refining early “hits” drawn from GARDP’s discovery programme into high-value “lead” candidates with strong antibacterial activity, low toxicity, formulations suitable for human use, and an overall profile fit for progression into preclinical development.

The work will particularly target carbapenem-resistant Gram-negative bacteria such as Acinetobacter baumannii, Pseudomonas aeruginosa and Klebsiella pneumoniae, which are increasingly difficult to treat and drive a growing number of severe hospital-acquired infections, sepsis cases and related deaths worldwide.

“We are excited to announce this collaboration. Drug-resistant infections are rising at an alarming pace, leaving patients worldwide with too few effective treatment options,” said Marc Lemonnier, CEO of Antabio. “By bringing together GARDP’s and Antabio’s strengths, we can speed up the development of novel treatments for life‑threatening infections from WHO priority pathogens like carbapenem‑resistant Gram‑negative bacteria – including hard-to-treat metallo‑β‑lactamase producers.”

GARDP’s discovery programme has a unique role in antimicrobial research, initiating and leading its own high-impact drug discovery projects with expert partners, geared at maximizing global health impact. To date, these projects have screened more than 280,000 compounds and advanced multiple novel chemical series through early profiling.

About GARDP

GARDP (the Global Antibiotic Research & Development Partnership) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland. www.gardp.org

About Antabio

Antabio is a clinical stage biopharmaceutical company developing novel antibacterial treatments targeting drug‑resistant infections identified by WHO and CDC as critical priorities, with a particular focus on life-threatening hospital infections. The company’s lead program, MEM-PIL (formerly MEM‑ANT3310), is a next‑generation β‑lactam/β‑lactamase inhibitor (BL/BLI) combination designed to treat multi-drug-resistant infections in hospital wards and ICUs. Antabio is supported by leading strategic and institutional investors such as the AMR Action Fund, EIC Fund, BNP Paribas Développement, Turenne/Relyens Santé, and IRDI Capital Investment. https://antabio.com/

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Français   German 

Geneva and Lausanne, Switzerland, 13 January 2026 – The GARDP Foundation (known as GARDP) and the privately-owned, global biopharmaceutical company Debiopharm today announced that they have entered into a collaboration and license agreement to pursue the development of Debio1453, a novel, first-in-class antibiotic targeting Neisseria gonorrhoeae. With 82 million new cases each year, and the continued spread of multidrug-resistant N. gonorrhoeae strains, gonorrhoea represents a global health crisis. This new partnership will help ensure that gonorrhoea continues to be a treatable disease and will alleviate the risk of the emergence of future resistance, by ensuring that the antibiotic pipeline continues to be replenished.

Gonorrhoea caused by N. gonorrhoeae is currently in danger of becoming untreatable because of antimicrobial resistance (AMR). Having developed resistance to almost all antibiotics used to treat it, only one last recommended treatment, ceftriaxone, remains effective, and now we are seeing a growing number of cases that are resistant to this. Even with the recent approval in late 2025 of two new first-in-class treatments for N. gonorrhoeae, there is growing concern that without ongoing development of innovative new treatments, like Debio1453, the rapid emergence of resistance will see this “super gonorrhoea” outpace antibiotic development.

“As a private company aligning our efforts with a not-for-profit organization, we see this collaboration with GARDP as a pioneering public-private model to expand global access to this innovative new drug candidate. The confirmation of this partnership is a powerful indicator of Debio1453’s potential to replenish a critically depleted antibacterial pipeline, addressing a severe therapeutic gap,” said Morgane Vanbiervliet, Director, Global Development and Licensing, Debiopharm. “For those struggling with multidrug-resistant gonorrhoea, this agreement signals a decisive step toward restoring effective treatment options and ensuring long-term antibiotic sustainability.”

With crucial funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the development of Debio1453 successfully progressed from a preclinical candidate to a clinical stage asset. As part of this new collaboration and license agreement, Debiopharm remains in charge of the completion of the Debio1453 phase 1 clinical trial, while GARDP will lead other non-clinical and clinical development activities, as well as chemistry, manufacturing and controls (CMC) activities. Both organizations aim to ensure that the global development and future access strategies of Debio1453 are aligned with country-specific regulatory requirements, health system realities and local economic constraints. Debiopharm has granted GARDP manufacturing and commercialization rights in relation to Debio1453 across more than 160 countries to ensure future global access.

“GARDP is committed to bringing new classes of antibiotics to market to tackle the rise and spread of AMR,” said Dr Manica Balasegaram, Executive Director of GARDP. “This new partnership demonstrates the flexibility of GARDP’s public-private partnership model. It is great to see a Swiss for-profit and a Swiss non-profit working together to develop an innovative new solution to address gonorrhoea and explore opportunities in other areas.”

The novel drug candidate Debio1453 offers significant hope, demonstrating strong activity against multidrug-resistant strains by targeting the essential FabI enzyme for bacterial survival, with the added crucial advantage of showing no cross-resistance to currently available antibiotic classes.

Untreated gonorrhoea can have a devastating impact on both men and women’s health, including infertility, ectopic pregnancy and pelvic inflammatory disease in women. It can also impact partners and increase HIV transmission risk. Babies born while a mother is infected with gonorrhoea are at risk of severe eye infections that can result in blindness.

The high financial and social costs of these effects are compounded by rapidly spreading antimicrobial resistance in N. gonorrhoeae, which prolongs infections and increases the long-term health burden globally. Because resistance spreads quickly and surveillance is often lacking, especially in resource-limited settings, the actual level of treatment failure is likely far higher than current reports indicate. This trend threatens health systems worldwide, including those in high-income countries.¹

Debiopharm’s commitment to patients

Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally.

Visit us: www.debiopharm.com/drug-development/

Follow us: https://www.linkedin.com/company/debiopharminternational/

About GARDP

GARDP (the Global Antibiotic Research & Development Partnership) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Commission, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation in Switzerland. www.gardp.org

Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Research, Technology and Space (BMFTR), the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF) and the Novo Nordisk Foundation. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

References
1. World Health Organization. Multi-drug-resistant gonorrhoeae. 2025 Oct 22 (https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea)

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Geneva and Lausanne, Switzerland, 14 January 2025 – The Global Antibiotic Research & Development Partnership (GARDP) and the Swiss-based global biopharmaceutical company Debiopharm have signed a memorandum of understanding to develop Debio 1453, a novel compound representing a new antibiotic class that targets Neisseria gonorrhoeae. Multidrug-resistant strains of N. gonorrhoeae have emerged globally, limiting treatment options and elevating this pathogen to the high-priority category on the World Health Organization’s Bacterial Priority Pathogen List. Such pathogens present distinct public health challenges that urgently require new treatments.

“Antibiotic-resistant gonorrhoea represents a serious threat to sexual and reproductive health,” said Morgane Vanbiervliet, Manager of Market Intelligence & Business Development, Infectious Diseases, Debiopharm. “Debio 1453 shows encouraging pre-clinical efficacy against resistant strains of N. gonorrhoeae. We are eager to continue to develop this compound in collaboration with GARDP.”

Debiopharm has completed the preclinical development of Debio 1453 with ongoing support from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). The MOU between Debiopharm and GARDP now sets the stage for a new partnership to develop the compound for regulatory approval and help make the final product available and affordable to treat patients worldwide.

“We are very pleased to lay the groundwork for a future partnership with Debiopharm,” said Yann Ferrisse, Director of Business Development at GARDP. “In line with our 2024-2028 strategy, we will continue to identify new opportunities like Debio 1453 to develop and make available treatments for gonorrhoea and other public health threats.”

Innovative approaches are necessary to treat N. gonorrhoeae, which has gradually developed resistance to many classes of antibiotics used to treat gonorrhoea infections. A single muscular injection of ceftriaxone is now the last available recommended treatment globally. Recent reports of outbreaks of ceftriaxone-resistant “super gonorrhoea” have heightened the urgency for new antibiotic treatments.

Debio 1453 shows promising activity against ceftriaxone-resistant and other multidrug-resistant strains of N. gonorrhoeae. The compound uses a unique and novel mechanism of action to target the FabI enzyme, on which N. gonorrhoeae relies for its growth and survival. In studies thus far, no cross-resistance to any antibiotic class has been observed.

With more than 82 million new gonorrhoea infections occurring globally each year, gonorrhoea is the third most common sexually transmitted infection. It can cause serious, lifelong consequences in men and women, and can amplify the spread of HIV in high-prevalence settings. When left untreated in women, gonorrhoea can lead to pelvic inflammatory disease that elevates the risk of complications in pregnancy, including the likelihood of ectopic pregnancies and infertility. Gonorrhoea can also be transmitted during birth to babies, who in turn can have health problems like gonococcal conjunctivitis.

Debiopharm

Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally.

For more information, please visit www.debiopharm.com
We’re on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews

GARDP

We are a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. We receive vital support from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Bill & Melinda Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. We are GARDP, the Global Antibiotic Research & Development Partnership. www.gardp.org

*CARB-X is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. Research reported in this press release is supported by CARB-X. CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views CARB-X or its funders.

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NIID and GARDP plan to design and deliver clinical trials that provide evidence for the optimal and appropriate use of new and existing antibiotic treatment regimens for serious bacterial infections caused by drug-resistant pathogens. Such trials would aim to improve patient outcomes so that fewer people suffer and die from AMR, as well as to identify effective alternatives to last-resort (i.e. carbapenem) antibiotics. By using these last-resort antibiotics less frequently, drug resistance toward them may be delayed and their lifespan extended.

“This collaboration opens the door to addressing priority AMR challenges within the Republic of Korea while benefiting the global community,” said Seamus O’Brien, R&D Director of GARDP. “We are eager to discuss plans for innovative studies that could improve the outcomes of patients with multidrug-resistant infections.”

According to a new study published in The Lancet, the number of people who die from antibiotic-resistant infections, already in the millions, is expected to start rising steeply after remaining flat for over three decades. From 2025 to 2050, the death toll is expected to increase by 70%, with the total number of deaths associated with antibiotic resistance reaching a staggering 169 million.

“AMR is a massive problem which no single institute or organization can fight alone. This agreement brings together NIID’s evidence-driven efforts to address the burden of infectious diseases and GARDP’s expertise in antibiotic development and access. Together, we hope to create synergies in antibiotic research and development,” said Hee-Chang Jang, Director General of NIID.

Beyond designing and delivering clinical trials, the agreement details possible collaboration on statistical analysis, quality management, safety and pharmacovigilance activities, as well as sharing knowledge to support country-level product registration and adoption of usage guidelines.

The relationship between NIID and GARDP marks the Republic of Korea’s rising leadership in the area of global health, as well as an increasing number of ties between GARDP and Korean researchers and global health leaders. GARDP receives critical funding from the RIGHT Foundation, a Korean funding agency that supports global health R&D. This funding enables GARDP’s collaboration with the Korean company Jeil Pharma to improve antibiotic regimens for neonatal sepsis. GARDP also collaborates with Institut Pasteur Korea in searching for novel compounds with antibacterial activity against drug-resistant bacteria.

NIID

The National Institute of Infectious Diseases (NIID) is a key research institute under the Korea National Institute of Health. It was founded in September 2020, alongside the inauguration of the Korea Disease Control and Prevention Agency, to address the growing need for national-level research on infectious disease response. This was prompted by the recurring crises caused by emerging infectious diseases like COVID-19, the rise of antibiotic-resistant bacteria due to environmental changes and the increasing prevalence of chronic infectious diseases associated with aging.

GARDP

We are a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. We receive vital support from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Bill & Melinda Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. We are GARDP, the Global Antibiotic Research & Development Partnership. www.gardp.org

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Geneva and Bangalore, 11 June 2024 – The Global Antibiotic Research & Development Partnership (GARDP) and Bugworks Research Inc. (Bugworks) today announced a collaboration agreement to co-develop an innovative compound (BWC0977) with broad-spectrum antibiotic activity against multidrug-resistant bacteria that cause life-threatening infections. Under the agreement, GARDP will provide up to US$20 million to Bugworks in technical and financial support for the pharmaceutical and clinical co-development of BWC0977. In return, Bugworks has granted GARDP manufacturing and commercialization rights for BWC0977 in 146 countries, almost all of which are low- or middle-income (LMICs).

BWC0977 has in vitro activity against a broad spectrum of pathogens that lead to serious hospital-acquired infections like pneumonia, bloodstream infections and complicated urinary tract infections. Among these pathogens are WHO critical priority pathogens, carbapenem-resistant Acinetobacter baumannii and Klebsiella pneumoniae, for which few treatment options exist. According to the GRAM study, these two pathogens alone account for over one-fifth of deaths associated with antimicrobial resistance (AMR) in 2019. The study also shows that, in many countries around the world, over 80% of A. baumannii clinical isolates were carbapenem-resistant.

“We are excited to work with Bugworks to make key investments at this critical stage in the development of compound BWC0977,” said Manica Balasegaram, Executive Director of GARDP. “Many compounds in the antibiotic pipeline lack innovative characteristics and fail to target priority pathogens. In contrast, BWC0977 stands out for its novelty and potential to address unmet public health needs.”

“Bugworks is delighted to partner with GARDP to advance compound BWC0977 through clinical development to treat a variety of drug-resistant bacterial infections,” said Anand Anandkumar, co-founder and CEO of Bugworks. “An overarching goal of this partnership is to enable access to this compound simultaneously in Western countries and in LMICs with high AMR burden. We are grateful to CARB-X for their continued support for BWC0977 from lead optimization to human clinical trials, thus enabling the asset to enter the GARDP collaborative orbit.”

The development of BWC0977 reflects the bolstering of the global health ecosystem to respond to the AMR crisis. Bugworks was set up in 2014 and incubated at the Centre for Cellular and Molecular Platforms (C-CAMP) in Bengaluru, India. Since 2017, CARB-X has provided critical support for the pre-clinical development and first-in-human (phase 1) clinical study of this compound, including US$12.47 million in funding. GARDP will now collaborate with Bugworks to further develop BWC0977 and, upon approval, enable global access.

“We are proud of our financial and non-financial support for the Bugworks programme, which began in lead optimization, delivered BWC0977 as a development candidate and ultimately commenced a first-in-human programme,” said Erin Duffy, R&D Chief at CARB-X. “Now that this compound has been primed for advanced development, we look forward to GARDP’s support in bringing this potential novel, broad-spectrum antibiotic to patients.”

GARDP’s technical and financial support of this project is tied to the successful completion of key R&D milestones that align with GARDP’s public health objectives. GARDP will initially bring expertise and financial support for critical aspects of BWC0977’s pharmaceutical development, including product formulation. Later investments will support clinical development and chemistry, manufacturing and controls activities to ensure that the final product is suitable for use in diverse countries and contexts, including low-resource settings.

About GARDP 

The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit organization that develops new antibiotic treatments for drug-resistant bacterial infections that pose the greatest threat to human health, and makes them accessible to the people who need them. It puts public health needs at the centre of antibiotic drug development to address the immediate crisis of antimicrobial resistance (AMR). Its work is funded by the governments of Canada, Germany, Japan, Monaco, the Netherlands, South Africa, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as Global Health EDCTP3, the RIGHT Foundation, Wellcome and other private foundations. GARDP was created by the World Health Organization and the Drugs for Neglected Diseases initiative (DNDi) in 2016 and legally registered as the GARDP Foundation in Geneva, Switzerland in 2018. http://www.gardp.org 

About Bugworks Research Inc. 

Bugworks Research Inc. (Bugworks) is a clinical-stage biopharmaceutical company that is developing novel multi-target therapeutic assets in the anti-infectives and oncology areas by integrating the latest innovations in computational biology, pharmacology, structural-biology, and medicinal chemistry. BWC0977 is currently in a Phase I clinical trial and is targeted to address unmet needs of serious hospital & community infections, and bacterial biothreats. Its lead asset for oncology is in the late pre-clinical stage, targets multiple cancers and is expected to be used either as standalone or in combination with immune checkpoint therapies. www.bugworksresearch.com

About CARB-X

CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development to address the rising threat of drug-resistant bacteria. CARB-X supports innovative therapeutics, preventatives and rapid diagnostics. CARB-X is led by Boston University and funded by a consortium of governments and foundations. CARB-X funds only projects that target drug-resistant bacteria highlighted on the CDC’s Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the WHO, with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list. https://carb-x.org/ | (formerly Twitter) @CARB_X

CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.

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Access to newer antibiotics tends to be limited to a small number of high-income countries. A 2018 study found that only 12 of the 25 new antibiotics that entered the market from 1999 to 2014 were registered in more than 10 countries. By pooling procurement of new antibiotics in the GARDP portfolio and utilizing GDF’s platform, GARDP and GDF will ease the procurement process by individual countries in GARDP territories, reduce wastage, lower prices and accelerate delivery for better patient outcomes and more cost-effective healthcare.

GDF is the largest procurer in the world of tuberculosis (TB) products, including TB diagnostics and therapeutics. Since 2001, GDF interventions have helped millions of people around the world get diagnosed and treated for TB who likely would not have been otherwise. The agreement between GARDP and GDF could have similar benefits for patients with non-TB bacterial infections.

“This partnership is a major step toward placing equity at the heart of the international response to AMR,” said Manica Balasegaram, Executive Director of GARDP. “By positioning AMR, like tuberculosis, as a public health issue to be prioritized, we can build an ecosystem for appropriate access to antibiotics for patients around the world.”

The partnership between GARDP and GDF reflects the increasing need to respond to the crisis of antimicrobial resistance through global coordination. TB is caused by the bacterium Mycobacterium tuberculosis. Like other bacteria, it can evolve to develop resistance to available treatments, making those treatments less effective in the population at large. Currently, GDF supports access to medications for all types of TB, including multidrug-resistant and extensively drug-resistant TB; now in partnership with GARDP, it is broadening its approach to antibiotics for drug-resistant infections more generally.

“We at Stop TB are delighted to show how investments in tools and platforms aimed at ending TB can be essential to supporting AMR efforts. By leveraging GDF’s network to distribute GARDP’s innovative antibiotics, we are enhancing access and ensuring that effective treatments reach those in dire need,” said Lucica Ditiu, Executive Director of the Stop TB Partnership. “Together, we are shaping a future where health equity is a reality.”

GDF’s success in facilitating access to TB medicines may hold the key to facilitating access to antibiotics in general. Given the small market size for TB medicines, there are high transaction costs and risks of wasted product. These factors and others disincentivize the development and production of TB medicines.

GDF has overcome access issues by developing critical tools and services, such as its strategic rotating stockpile. This physical inventory of TB medicines, which is stored at the warehouse of GDF’s contracted procurement agent, helps lower prices by pooling procurement, sharing risks and decreasing supplier transaction costs. Since 2019, for example, GDF has overseen a 25-40% price decrease in new WHO-recommended all-oral regimens for drug-resistant TB.

GARDP in turn engages in license and sublicense agreements and, with local partners, implements product introduction plans, among other key activities. Together these activities aim to support reliable supply of products at sustainable, affordable prices.

“Adapting GDF’s existing set of tailored systems and tools to address AMR is a cost-effective means to improve the lives of millions of people. We are stronger by working together on all parts of the product life cycle, leveraging the relative strengths across GARDP and GDF,” said Brenda Waning, Chief of GDF at the Stop TB Partnership.

GARDP and GDF will initially focus on developing access plans for cefiderocol. This antibiotic is approved in the US, EU, and Japan to treat certain gram-negative bacterial infections with limited treatment options. In the future, GDF will also incorporate, upon regulatory approval, zoliflodacin for uncomplicated gonorrhoea and other antibiotics from GARDP’s portfolio.

About GARDP
The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit organization that develops new antibiotic treatments for drug-resistant bacterial infections that pose the greatest threat to human health, and makes them accessible to the people who need them. It puts public health needs at the centre of antibiotic drug development to address the immediate crisis of antimicrobial resistance (AMR). Its work is funded by the governments of Canada, Germany, Japan, Monaco, the Netherlands, South Africa, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as Global Health EDCTP3, the RIGHT Foundation, Wellcome and other private foundations. GARDP was created by the World Health Organization and the Drugs for Neglected Diseases initiative (DNDi) in 2016 and legally registered as the GARDP Foundation in Geneva, Switzerland in 2018. www.gardp.org

About GDF
The mission of Stop TB’s Global Drug Facility (GDF) is to facilitate world-wide, equitable, and timely access to tuberculosis (TB) medicines, diagnostics, and devices. Working across both supply and demand sides of the market, GDF provides incentives for suppliers to develop new TB products, technical assistance on demand generation to rapidly introduce new products, and a unique set of tools and services to ensure an uninterrupted supply of products in countries. GDF also serves as the global TB market steward, bringing together partners and stakeholders to align on priority issues and coordinate policy, regulatory, and other interventions towards maximining access to TB products.

Since its creation in 2001, GDF has facilitated access to TB medicines and diagnostics in more than 160 countries. In 2023 alone, GDF delivered more than USD320 million worth of TB medicines and diagnostics to a diverse client base across 134 countries. GDF has led the introduction of advanced diagnostics and supplies, longer and shorter all-oral regimens for drug-resistant TB, and child-friendly medicines for both drug-sensitive and drug-resistant TB.

About the Stop TB Partnership
The Stop TB Partnership is a unique United Nations hosted entity based in Geneva, Switzerland, committed to revolutionizing tuberculosis (TB) space to end the disease by 2030. The organization aligns more than 2,000 partners worldwide to promote cross-sectoral collaboration. The Stop TB Partnership’s various teams and initiatives take bold and smart risks to identify, fund and support innovative approaches, ideas, and solutions to ensure the TB community has a voice at the highest political levels and that all TB-affected people have access to affordable, quality, and people-centered care.

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