Sponsored by the GARDP Foundation (known as GARDP), the NeoSep1 clinical trial in India began with the first baby recruited at Jawaharlal Postgraduate Education Institute of Medical and Research (JIPMER) in Puducherry, followed by Pt. B.D Sharma PGIMS in Rohtak. Mumbai’s Lokmanya Tilak Municipal College and General Hospital is expected to start enrolling newborns shortly.

The study is also getting underway in hospitals in Vietnam and Pakistan, and will soon start in Malaysia, Bangladesh and Uganda. NeoSep1 aims to enrol 3,000 newborns across Asia and Africa by the end of 2028. So far, newborns have been enrolled in Ghana, Kenya and South Africa.

“With underdeveloped immune systems, newborns are especially prone to life-threatening sepsis,” said Sally Ellis, Children’s Antibiotics Project Leader for GARDP. “Today, we stand at a tipping point. The antibiotics for newborns that we have relied on for decades are failing against resistant infections, in many hospital settings. This trial, led by GARDP and partners, is about giving neonatologists new tools, and giving babies with sepsis a fighting chance at life.”

Part 2 of the NeoSep1 trial is pioneering the use of a Personalised Randomised Controlled Trial (PRACTical) design, which will evaluate and rank multiple antibiotic regimens for newborns with sepsis. This approach will help clinicians choose effective treatments best suited to their local context.

The goal of the trial is to identify one or more safe, effective, and affordable treatments that can reduce the high number of newborn deaths caused by drug-resistant sepsis, especially in low- and middle-income countries. The trial will provide critical data to inform much-needed updates of international and national treatment guidelines for neonatal sepsis.

Part 1 of the NeoSep1 trial, conducted in South Africa and Kenya in 2023, assessed and validated the appropriate dose for fosfomycin and flomoxef for use in newborns, when used in combination with other antibiotics.

“Every day doctors face the heartbreaking reality of losing babies to sepsis due to lack of safe and effective treatments,” said Dr Nishad Plakkal, Principal Investigator of the NeoSep1 trial in India and Associate Dean (Research) and Professor and Head, Department of Neonatology at JIPMER. “Having the right antibiotics at the right dose can tip the balance between life and death. This trial offers hope to change that.”

Each year, up to three million newborns around the world develop neonatal sepsis, a life-threatening bloodstream infection that is especially common in Asia and sub-Saharan Africa. In these regions, the burden is felt most acutely, as access to timely diagnosis and effective antibiotic treatment is often limited.

In 2019 alone, an estimated 238,500 newborn deaths across South Asia, Southeast Asia, and Oceania were associated with antimicrobial resistance (AMR). Of these, 63,200 newborn deaths were directly caused by infections that no longer responded to the standard antibiotics available. These findings, from the Global Research on Antimicrobial Resistance (GRAM) study, underscore a growing crisis: infections that were once treatable are becoming increasingly difficult – and sometimes impossible – to treat, placing the world’s most vulnerable patients at even greater risk.

NeoSep1 is sponsored by GARDP in collaboration with the UCL Innovative Clinical Trials Unit; City St George’s, University of London (SGUL), and Penta Foundation.

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

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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

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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/

Source

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)

Source

Geneva (Switzerland), 12 December 2025 – The Global Antibiotic Research & Development Partnership (GARDP) today announced that the US Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin) for oral suspension, a first-in-class, single-dose, oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. This is the first new treatment to be developed solely for gonorrhoea in decades and the first to be developed using a novel not-for-profit approach to antibiotic research and development (R&D) aimed at tackling the rise and spread of antimicrobial resistance (AMR).  

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). Neisseria gonorrhoeae has developed resistance to almost all antibiotics used to treat it, with only one last remaining recommended antibiotic treatment, ceftriaxone. Now we are seeing resistance even to this, with a six-fold increase of these kinds of resistant infections in some regions in recent years. Without new and effective antibiotics, like zoliflodacin, gonorrhoea is in danger of becoming one of the first diseases to become once again untreatable because of AMR.  

Zoliflodacin was developed as part of a public-private partnership with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), which is the marketing authorization holder in the United States and was responsible for filing the New Drug Application (NDA) with the FDA. The zoliflodacin approval follows a pivotal phase 3 clinical trial, that was sponsored and led by GARDP, and met its primary objective when compared against the current global standard of care. The findings of this trial were published on 11 December in The Lancet. Also, in previous in vitro studies, zoliflodacin has 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 huge turning point in the treatment of multidrug-resistant gonorrhoea, which until now has been outpacing antibiotic development,” said Dr Manica Balasegaram, Executive Director of GARDP. “Zoliflodacin shows that a different public-private partnership approach to antibiotic development is possible — one that prioritizes global health needs, strengthens access where the burden is highest and protects the effectiveness of new drugs for the long-term.” 

The phase 3 trial, for example, was not just the largest clinical trial ever conducted for a new treatment against gonorrhoea, it was also one of the most geographically and demographically diverse. Involving 930 participants across 16 trial sites within five countries in four continents – including Belgium, the Netherlands, South Africa, Thailand, and the US – the trial was designed to be conducted in regions with high prevalence of gonorrhoea and include underrepresented populations, such as women, adolescents and people living with HIV.  

“Gonorrhoea continues to be a significant public health concern worldwide, and the growing challenge of antimicrobial resistance only heightens the urgency for new treatment options,” said Dr. Edward (Ned) Hook, MD, Emeritus Professor of Medicine at the University of Alabama at Birmingham and protocol chair of the study. “The decades-long absence of new gonorrhoea treatments, combined with rising antibiotic resistance, has created significant challenges in managing this common and potentially serious sexually transmitted infection.” 

Zoliflodacin belongs to a new class of antibiotics, called spiropyrimidinetriones, which has a unique mechanism of action in the way that it inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. Zoliflodacin is being developed exclusively for the treatment of gonorrhoea. By focusing solely on this indication, the aim is to limit the clinical use of this new treatment to the targeted infection only. This approach can help to minimize the likelihood of excessive use, which could potentially contribute to the development of resistance, and therefore preserve the usefulness of zoliflodacin in treating gonorrhoea infections for longer.  

“As clinicians, we see the devastating impact drug-resistant gonorrhoea can have on people’s lives in Thailand,” said Dr Rossaphorn Kittiyaowamarn, Principal Investigator for Bangrak STI Medical Center, Thailand’s Ministry of Public Health site. “With the number of cases on the rise, there is also huge value in carrying out trials in high-burden countries and among high-burden populations to bring about effective treatment options. Having a single-dose, oral treatment like this will be a game changer for gonorrhoea control. This is essential to reduce the burden of disease for individuals and to prevent the spread of highly drug-resistant gonorrhoea globally.”  

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 zoliflodacin in the major markets in North America, EU and Asia-Pacific. 

Innoviva Specialty Therapeutics will continue to collaborate with GARDP to advance regulatory filings with the European Medicines Agency. In addition, GARDP is taking steps to obtain market authorization initially in Thailand and 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. In November 2025, zoliflodacin was submitted for priority review in Thailand, with a submission in South Africa planned for early 2026. GARDP is committed to generating more data where required to support expanded access to zoliflodacin.  

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 new chemical entity, 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 GARDP 

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, 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. www.gardp.org 

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“We are truly grateful for the government’s continued support to GARDP as it signals Japan’s readiness to fight the growing threat of antimicrobial resistance (AMR),” said Manica Balasegaram, Executive Director of GARDP. “This contribution reflects Japan’s steadfast leadership in global health innovation.”

As a member of both the G7 and G20, Japan has been a global leader in advocating for the importance of addressing AMR and driving international discussions on the issue.

“The Government of Japan is committed to working with the international community to address AMR, a cross-border public health threat. Our continued support to GARDP will help strengthen infectious disease responses globally and accelerate the development of new antibiotics that we all need,” said Dr. Satoshi Ezoe, Senior Assistant Minister for Global Health, Ministry of Health, Labour and Welfare. “Our financial support is complemented by strong collaboration with the Japanese pharmaceutical, medical technology and research sectors.”

Globally, AMR is already a leading global health threat, associated with 4.7 million deaths annually. But the latest research suggests that this global crisis will continue to worsen and it has reached an alarming tipping point. AMR mortality has remained relatively stable in recent decades, but is now expected to rise sharply, with the number of AMR-related deaths increasing by more than 70% by 2050.  During this time, AMR is forecast to kill 39.1 million people, with 169 million associated deaths.¹

In just over five years of collaboration with the Japanese government, GARDP has leveraged the expertise and innovation of the country’s robust science and technology sectors, including creating partnerships with the pharmaceutical firms and JIHS (the Japan Institute for Health Security).

Most recently, GARDP and the Institute of Science Tokyo jointly launched a research project on drug discovery using the university’s advanced capabilities in X-ray crystallographic analysis. The collaboration leverages Japan’s technical strengths to support the identification and characterization of promising compounds in the fight against AMR. This research may contribute to the discovery of innovative antibiotics that could help counter AMR.

 ¹ GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050. Lancet 2024; 404: 1199–226

 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. 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 Union, as well as the 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. GARDP is registered under the legal name GARDP Foundation. www.gardp.org

Media contacts:

• Yoko Noda in Tokyo (Japanese/English): ynoda@dndi.org | +81 70 4465 5453

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The research focuses on a particular protein that is essential for the survival of Gram-negative pathogens like Escherichia coli and Klebsiella pneumoniae, both of which are WHO priority bacterial pathogens in urgent need of new treatments. This protein target has not yet been successfully disabled by existing antibiotics. As such, this protein is an “unrealized target,” a critical area of research in the discovery of new antibiotics with potential to treat drug-resistant infections.

“If this project is successful, we’ll gain access to important structural data that will help refine the design of these compounds. This research may contribute to the discovery of innovative antibiotics that could make a significant contribution to efforts to counter antimicrobial resistance,” said Professor Satoshi Murakami, an expert in structural biology who will lead this project at Institute of Science Tokyo.

This project leverages Professor Murakami’s world leading protein crystallography work at Institute of Science Tokyo. GARDP and Institute of Science Tokyo will attempt to co-crystalize the target protein with candidate compounds provided by GARDP. Researchers will then determine the structures of the resulting complexes at atomic resolution using techniques such as X-ray crystallography.

“We are excited to collaborate with Professor Murakami on this target-based discovery research project. The project is an excellent fit for our portfolio and aligns with our approach to partnering on the discovery and delivery of novel pre-clinical candidates to tackle antimicrobial resistance,” said Alan Hennessy, Head of Discovery at GARDP.

This project is part of a stream of work that GARDP has undertaken with Japanese partners and support. The Government of Japan has been a GARDP funder since 2020, investing US$ 9 million in GARDP to date. As a member of both the G7 and G20 Group of Nations, Japan has been a prominent advocate and global leader in the fight against AMR. Several Japanese companies have actively partnered with GARDP, notably in the areas of antibiotic discovery and access as well as on antibiotic R&D for children.

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. 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 Union, as well as the 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. GARDP is registered under the legal name GARDP Foundation.

www.gardp.org

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Accra (Ghana), 17 June 2025 – A new global collaboration has been launched to accelerate access to and effective use of diagnostics in the global effort to address antimicrobial resistance (AMR). The new initiative will aim to address the urgent need for a collaborative approach to scale up the use of diagnostics to address AMR.

The collaboration, convened at the University of Ghana, brings together global and regional leaders to strengthen diagnostic innovation, implementation, and equity with a focus on low- and middle-income countries where the burden of AMR is highest. Led by The Fleming Initiative, GARDP, and FIND, the two-day launch meeting featured a series of expert-led sessions on diagnostic access, innovation, policy, data use, and market shaping.

Partners contributing to the collaboration include the Wellcome Trust, Africa CDC, CAMO-Net, WACCBIP, Cepheid, and the Ghana Ministry of Health, with further support from CARB-X, ICARS, the Global AMR R&D Hub, and the Fleming Fund. With representatives from a wide range of institutions, from national governments to the World Health Organization (WHO), participants agreed on the need to build on the momentum of the inaugural meeting in Ghana by ensuring strong leadership from low- and middle-income countries in shaping the collaboration’s future.

“This is just the beginning,” said Professor Gordon Awandare, Director of WACCBIP, who hosted the launch. “Being able to host the launch at the University of Ghana affirms the importance of African institutions leading global conversations about AMR. We’re proud to be part of building a roadmap for change.”

Professor Alison Holmes OBE, Director of the Fleming Initiative and co-convener of the launch event, added: “To effectively address AMR, we must embed diagnostics at every level of healthcare. That means listening to, learning from, and working with those closest to the challenge.”

Dr Silvia Bertagnolio, Head of the AMR surveillance, Research and Laboratory Strengthening Unit at WHO, who spoke at the launch, emphasised the critical role this new global diagnostics collaboration could play alongside WHO in addressing AMR: “I see a strong opportunity for this collaboration to be established as an integral part of the broader WHO Global Coalition on Diagnostics, and to play a key role in supporting WHO’s AMR Diagnostic Initiative.  Ensuring alignment and coherence with these global efforts is essential to closing healthcare gaps and positioning diagnostics at the forefront of the global response to antimicrobial resistance.”

A public report summarising discussions and next steps will be made available within a month. Further details on the collaboration’s goals and governance structures will be shared later this year.

Further information:

• The DxAMR collaboration website
• WHO’s work on diagnostics
• WHO’s Global Diagnostics Coalition TOR
• WHO’S AMR Diagnostics information

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• In laboratory studies, zoliflodacin has been shown to be active against Neisseria gonorrhoeae including multidrug-resistant strains.
• If approved, zoliflodacin could become the first new antibiotic treatment for gonorrhoea in decades.

Waltham, MA (USA) and Geneva (Switzerland), 10 June 2025 – Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhoea in decades.

With more than 82 million new gonorrhoea infections occurring globally each year, gonorrhoea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences.

With the rise and spread of drug-resistant infections and the World Health Organization (WHO) identifying antimicrobial resistance (AMR) as one of the ten most critical global threats to public health, the bacterium Neisseria gonorrhoeae has progressively developed resistance to many classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984.

“Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhoea, including infections caused by drug-resistant strains,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics. “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.”

Recent reports (The Lancet Infectious Diseases) of emergent ceftriaxone-resistant infections have heightened the urgency for new antibiotics. Effective treatment options are essential to reducing the burden of disease for individuals and preventing the spread of highly drug-resistant gonorrhoea globally. If left untreated, gonorrhoea can also cause infertility in women, life-threatening ectopic pregnancies, and pelvic inflammatory disease.²

The FDA’s acceptance of the zoliflodacin NDA is based on the totality of data collected from several clinical trials as part of an innovative public-private partnership with GARDP. These trials include a pivotal Phase 3 clinical trial which demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection of a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial.

“This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Dr. Manica Balasegaram, Executive Director, Global Antibiotic Research Development Partnership (GARDP). “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.”

Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In vitro studies have demonstrated its activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. This investigational antibacterial is administered in a single, oral dose, simplifying treatment by providing a convenient option for patients unable to receive an intramuscular injection.

The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Innoviva Specialty Therapeutics, Inc., anticipates that the NDA review will proceed according to the standard process for drugs with this designation.

Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use.

About GARDP

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, 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 Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. 

About Innoviva

Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR^®/BREO^® ELLIPTA^® and ANORO^® ELLIPTA^®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA^® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA^® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA^® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. For more information about Innoviva, go to www.innoviva.com. For information about Innoviva Specialty Therapeutics, go to www.innovivaSpecialtytherapeutics.com.

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