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

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• 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/São Paulo, 22 July 2026 — Patients across Latin America and the Caribbean are being left without access to the critical antibiotics needed to treat life-threatening drug-resistant infections, according to a new review led by the GARDP Foundation (known as GARDP) published today. 

The review highlights how more than a third of countries in the region do not include even a single Reserve (or a “last-resort”) antibiotic on their national essential medicines lists, despite a growing and devastating burden of antimicrobial resistance. 

Drug-resistant infections contributed to more than 320,000 deaths across Latin America and the Caribbean in 2021 and could cause nearly 650,000 deaths annually by 2050 without further action, based on recent estimates. 

“There is a widening disconnect between where drug-resistant infections are taking the greatest toll and where effective antibiotics are actually available,” said Dr Regina Osih, GARDP’s Global Access Director. “If that gap is not urgently addressed, more people will lose their lives to bacterial infections that are becoming increasingly difficult to treat.” 

The review points to several major challenges affecting patient access to these lifesaving medicines, from delays in regulatory approvals, to exclusions from treatment guidelines and essential medicines lists, and high pricing. In addition, it reveals a crippling ‘two-tier’ system in treatment access between public and private hospitals, which fuels inequities within as well as between countries.  

Years-long delays in access to newer treatments 

The findings come as resistance to existing treatments increases. A regional analysis of intensive care units found that nearly one-third of Gram-negative bacterial isolates were resistant to carbapenems – antibiotics commonly used as a last line of defence against severe bacterial infections. Resistance in Acinetobacter baumannii, a major cause of hospital-acquired infections, exceeded 70%. 

At the same time, newer treatments are taking years to reach countries facing the highest rates of resistance. Eight years after receiving approval from the U.S. Food and Drug Administration in 2014, ceftolozane-tazobactam had been registered in only nine low- and middle-income countries in Latin America and the Caribbean and even then, remained unavailable in four of them, the review found.  

The review also points to delays in access to cefiderocol, a newer antibiotic used to treat some of the deadliest multidrug-resistant Gram-negative infections. By 2025, it had not been registered anywhere in the region. Through an innovative partnership, GARDP and Japanese pharmaceutical company Shionogi are now working to address this challenge, support its responsible introduction in the region and beyond.  

Regional collaboration offers a strategic way forward 

Since Reserve antibiotics are intended to be used sparingly – only when other treatments are likely to fail – this can make them less commercially attractive to register and supply, particularly in smaller or lower-income markets. The result is a mismatch between public health need and market incentives, leaving many countries waiting years to access critical treatments. 

To help address this challenge, the authors call for faster regulatory pathways, including shared reviews between countries, coordinated procurement, stronger regional manufacturing capacity, and updated essential medicines lists. They highlight regional initiatives such as the Pan American Network for Drug Regulatory Harmonization and the PAHO Strategic Fund that can help countries join forces to expand antibiotic availability. They also propose dedicated and funded national AMR programmes to ensure a robust response. 

“Access to effective antibiotics should not depend on where a patient lives,” said one of the paper’s authors, Dr Wanda Cornistein, Specialist in Internal Medicine and Infectious Diseases and Head of the Infection Control Unit at Austral University Hospital, Buenos Aires. “Countries need stronger systems to decide which antibiotics are essential, secure them at affordable prices and ensure they are used appropriately. Without that, the gulf between rising drug resistance and access to treatment will continue to grow.” 

The review, Access to Reserve Antibiotics in Latin America and the Caribbean: Situation, Challenges, and Future Directions, was published in the journal Infection and Drug Resistance.  

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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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.  

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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/

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

• 米国食品医薬品局（FDA）は、数十年ぶりに淋菌感染症（淋病）治療向けに開発された

け ん だ く

抗菌薬であるヌゾルベンス（NUZOLVENCE®、一般名：ゾリフロダシン）（経口 懸濁 液

用） を承認しました。

• この決定は、薬剤耐性淋菌の治療における大きな転換点となるでしょう。
• 非営利団体の主導によるこの画期的な取り組みは、世界的な薬剤耐性（AMR）との闘いにおける、新しい抗菌薬研究開発のありかたを示しています。

スイス・ジュネーブ発 – グローバル抗菌薬研究開発パートナーシップ（GARDP）は 12 月 12 日、米国食品

け ん だ く

医薬品局（FDA）が、ヌゾルベンス（ゾリフロダシン）（経口 懸濁 液用）を承認したことを発表しまし

た。本剤は、体重 35kg 以上の 12 歳以上の小児および成人における単純性の尿路性器淋菌感染症に対する治療を目的とした単回投与の経口抗菌薬であり、同感染症の治療に用いられるファーストインクラスの薬剤です。これは、数十年ぶりに登場した淋菌感染症に特化した新しい治療薬であるとともに、これまでに例のない非営利団体の主導によって開発された、薬剤耐性菌の拡大に対処するための画期的な新薬です。

世界で年間 8,200 万件以上の新規淋菌感染症が発生する中、ゾリフロダシンはこの性感染症に苦しむ患者にとって待望の治療選択肢となります。淋菌（Neisseria gonorrhoeae）は、治療に用いられてきたほぼすべての抗菌薬に耐性を獲得しており、現在推奨されている最後の治療薬はセフトリアキソンのみです。しかし一部の地域では近年、感染例のうち同薬に対する耐性菌の割合が 6 倍に増加しており、深刻な状況となっています。ゾリフロダシンのような新しく効果的な抗菌薬がなければ、淋菌感染症は薬剤耐性によって治療不能な疾患の仲間入りをしていたかもしれません。

ゾリフロダシンは、イノビバ社（NASDAQ: INVA）の子会社であるイノビバ・スペシャルティ・セラピューティクス社との官民パートナーシップを通じて開発されました。米国では、イノビバ・スペシャルティ・セラピューティクス社が新薬承認申請を行い、販売承認を受けています。（背景説明資料（英文））今回の承認は、 GARDP が出資・主導した第 3 相臨床試験の結果に基づくもので、この試験では、国際的な標準治療法との比較においてゾリフロダシンは主要評価項目を達成しました。試験結果は 12 月 11 日付で医学誌

『The Lancet』に掲載されています。さらに、過去の in vitro 試験においても、ゾリフロダシンはすべての多剤耐性淋菌株に対して活性を示し、他の抗菌薬に対する交差耐性は認められませんでした。

「淋菌の多剤耐性化に対し、これまで抗菌薬の開発は遅れを取ってきましたが、今回の承認はこの感染症の治療における大きな転機となります。またゾリフロダシンは、従来とは異なる官民パートナーシップによる抗菌薬開発が可能であることを証明しました。この取り組みは、世界の公衆衛生上のニーズに注目し、影響

の大きな地域で抗菌薬へのアクセスを確保し、新薬の有効性を長期にわたり維持することを目指しています。」と GARDP 代表のマニカ・バラセガラム医師は述べています。

今回の第3 相試験は、新規の淋菌感染症治療薬を対象とした臨床試験として過去最大規模であるだけでなく、地理的・人口統計的にも極めて多様な試験でした。この試験には、4 大陸 5 カ国（ベルギー、オランダ、南アフリカ、タイ、米国）の 16 の試験施設から 930 名の患者が登録されました。試験は、淋菌感染症の有病率が高い地域で実施され、女性、青年、HIV 陽性者など、従来の試験では対象とされることが少なかった集団を含むよう設計されました。

「淋菌感染症は世界的に重大な公衆衛生上の懸念事項であり、薬剤耐性の深刻化は新規治療薬の緊急性を一層高めています。数十年にわたる新薬の不在と耐性菌の増加により、このありふれた性感染症の治療は非常に難しくなっています。」と、アラバマ大学バーミンガム校医学部名誉教授で、試験計画の責任者であり本試験の設計と実施を監督したエドワード（ネッド）・フック医学博士は述べています。

ゾリフロダシンは、スピロピリミジントリオン系と呼ばれる新しいクラスの抗菌薬に属し、細菌の機能と増殖に不可欠な「II 型トポイソメラーゼ」という酵素を阻害する独自の作用機序を持っています。ゾリフロダシンは、淋菌感染症の治療専用に開発され、この適応に特化することで、対象感染症以外に臨床使用されないことを企図しています。このアプローチにより、過剰使用による耐性菌の発生リスクを最小限に抑え、ゾリフロダシンの有効性をより長く維持することが期待されています。

「タイ国内の医療現場においては、薬剤耐性の淋菌感染症が人々の生活に深刻な影響を与えている現状を身近に感じています。症例が増加する中で、より良い治療法を提供するために、影響の大きな地域や集団を対象に試験を実施することは大きな意義があります。今回のような単回投与の経口治療薬は、淋菌感染症の制御においてゲームチェンジャーとなるでしょう。これは、患者の疾病負担を軽減し、薬剤耐性淋菌の世界的な拡散を防ぐために不可欠です。」と、タイ保健省バンラック性感染症医療センターの主任研究者であるロッサポーン・キッティヤオワマーン医師は述べています。

GARDP は、世界の 4 分の 3 以上の国々でゾリフロダシンの承認取得と販売に関する権利を有しており、その中にはすべての低所得国、大半の中所得国、さらに複数の高所得国が含まれます。一方、イノビバ・スペシャルティ・セラピューティクス社の関連会社であり、以前のライセンス保持者であるエンタシス・セラピューテ ィクス社（Entasis Therapeutics, Inc.）は、北米、EU、アジア太平洋地域の主要国におけるゾリフロダシンの商業権を留保しています。

イノビバ・スペシャルティ・セラピューティクス社は、欧州医薬品庁（EMA）への承認申請に向けて GARDP と引き続き連携します。上記に先立ち、GARDP は、まずタイと南アフリカで販売承認取得への準備を進めています。両国は GARDP にとって重要なパートナーであり、第 3 相試験でも中心的な役割を果たしたことから、最初の申請国の候補となりました。2025 年 12 月初旬、タイでゾリフロダシンの優先審査申請が行われました。南アフリカでは 2026 年初頭に申請が予定されています。GARDP は、ゾリフロダシンへのアクセスを拡大するため、必要に応じて追加データを取得することを約束しています。

ゾリフロダシンの開発に関する GARDP の取り組みは、ドイツ連邦政府（研究・技術・宇宙省および保健省）、英国政府（保健・社会福祉省の一部である「グローバル AMR イノベーション基金(GAMRIF)」および現在の外務・英連邦・開発省に統合された旧国際開発省）、日本政府（厚生労働省）、オランダ政府（健康・福祉・スポーツ省および外務省）、スイス連邦政府（保健庁）、ルクセンブルク大公国、スイス・ジュネーブ州、南アフリカ医学研究評議会（SAMRC）、そしてレオ・モデル財団からの支援を受けています。また、この取り組みは、アストラゼネカ社が新規化学構造を最初に特定した初期研究と、米国国立アレルギー・感染症研究所（NIAID）がスポンサーとなった極めて重要な第 2 相臨床試験の成果を基盤としています。

GARDP | Global Antibiotic Research and Development Partnership

（グローバル抗菌薬研究開発パートナーシップ）

GARDP（ガードピー）は、公衆衛生上の深刻な問題のひとつである薬剤耐性菌感染症の増加と蔓延から人々を守るために活動する非営利のグローバルヘルス組織です。私たちは、官民パートナーシップを通じ、抗菌薬を必要とする人々のために抗菌薬および抗菌治療法を開発し、利用できるようにしています。

私たちの活動は、カナダ、ドイツ、日本、モナコ、オランダ、スイス、英国、ジュネーブ州政府、欧州連合

（EU）、 ビル＆メリンダ・ゲイツ財団、グローバルヘルス EDCTP3、GSK、RIGHT 財団、南アフリカ医学研究評議会 （SAMRC）、ウェルカム財団からの支援で支えられています。GARDP は、GARDP 財団という法人名で スイスで登録されています。 www.gardp.or（日本語情報）

【本プレスリリースに関するお問い合わせ】   GARDP（日本）広報担当 DNDi Japan 野田 葉子 ynoda@dndi.org/ 電話: 070-4465-5453

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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