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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Authors

Sarah M. McLeod, Samir H. Moussa, Meredith Hackel, Carmen Au, Pierre Daram

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For decades, the global pipeline for developing new antibiotics has worked in reverse – prioritising the countries least affected by bacterial infections, while leaving those with the greatest need waiting.

That is why the licencing in Thailand of zoliflodacin – a new antibiotic for gonorrhoea – matters so much. Coming just six months after its initial authorisation in the US, it marks a significant break from a long-entrenched tradition and is a big step forward for global health.

Multi-drug resistant gonorrhoea –- often called super-gonorrhoea –- first emerged in Asia but has since spread to Europe, with the UK reporting one of the most dangerous cases in 2018. The early licencing of a drug to tackle it in Asia will hopefully be felt all around the world.

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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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Why should a surge in sexually transmitted infections (STIs) in Europe be a concern across Africa or for people who don’t consider themselves to be at risk? Because it points to a bigger problem: the ease with which drug-resistant infections are now spreading, and not just in hospitals but within the community too.

The speed and scale at which people travel and interact in our interconnected world is increasingly helping to drive this, allowing drug-resistant pathogens to move rapidly through populations and across the world – including between high-income countries and low- and middle-income countries (LMICs), where the burden is often greatest and surveillance more limited.

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Advancing the development of a novel gonorrhoea drug.

Historical experience with Neisseria gonorrhoeae demonstrates that reliance on a single antibiotic class leads to the predictable erosion of susceptibility over time. Therefore, in addition to GARDP’s work on zoliflodacin, it is looking at options for additional treatments for gonorrhoea and assessing the need to secure better optimal treatments for STIs. 

In light of this, GARDP and Debiopharm have entered into a collaboration and license agreement to pursue the development of Debio1453, a novel antibiotic targeting N. gonorrhoeae. The partnership will help ensure that gonorrhoea continues to be a treatable disease and will alleviate the risk of future resistance emerging, by ensuring that the antibiotic pipeline continues to be replenished.

Having developed resistance to almost all antibiotics used to treat it. Only one last recommended treatment, ceftriaxone, remains effective, and 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 “super gonorrhoea” outpace antibiotic development.

What is Debio1453 and how does it work?

Debio1453 is a novel candidate that has demonstrated strong activity against multidrug-resistant strains of gonorrhoea by targeting the FabI enzyme, essential for bacterial survival, with the added crucial advantage of showing no cross-resistance to currently available antibiotic classes.

GARDP’s role in advancing Debio1453.

Debio1453 successfully progressed from a preclinical candidate to a clinical stage asset with crucial funding from CARB-X. As part of the agreement with GARDP, 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.

The potential impact

The collaboration aims 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 for Debio1453 across more than 160 countries to ensure future global access. The partnership also demonstrates the flexibility of GARDP’s public-private partnership model where a Swiss for-profit and a Swiss non-profit are working together to develop an innovative new solution to address gonorrhoea.

Where does the project stand?

GARDP and Debiopharm have just kicked off the collaboration and license agreement to pursue the development of Debio1453.

Key milestones

Signed

2025 – GARDP signed a memorandum of understanding with Debiopharm to explore co-development of Debio1453.

Signed

2026 – GARDP signed a collaboration and license agreement with Debiopharm to advance the development of Debio1453.

Resources

Partners

13 January 2026

GARDP and Debiopharm partner to advance development of novel gonorrhoea drug

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Media Coverage

13 January 2026

GARDP, Debiopharm to collaborate on new gonorrhea antibiotic

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What is zoliflodacin and how does it work?

Zoliflodacin belongs to a new class of antibiotics, called spiropyrimidinetriones, which has a unique mechanism of action. This inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction.

Key milestones

Signed

2017 – GARDP signed a collaboration agreement with Entasis Therapeutics Inc. (now Innoviva Specialty Therapeutics) to develop and register zoliflodacin.

EnrolMENT

2019 – Patients enrolled at all sites in phase 3 trial of zoliflodacin.

Announced

November 2023 – Topline data for phase 3 trial.

Published

December 2025 – Positive results of the phase 3 trial published in The Lancet. 930 participants across 16 trial sites within five countries in four continents – including Belgium, the Netherlands, South Africa, Thailand and the US – took part in the trial.

Approved

December 2025 – NUZOLVENCE® (Zoliflodacin) received US FDA approval.

APPROVED

June 2026 – NUZOLVENCE® (Zoliflodacin) received Thai FDA approval.

Resources

Partners

27 July 2026

Thai FDA approves NUZOLVENCE® (zoliflodacin) just six months after US authorization

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GARDP Publications

27 February 2026

Evaluation of Drug–Drug Interaction Potential Between the Oral Antibiotic Zoliflodacin and the CYP3A4 Inhibitor Itraconazole: A Phase 1 Study in Healthy Participants

Alison Luckey, Kajal B. Larson, Noha Rayad, Markus Heep, Sophie Delhomme, Gabrielle Kornmann, John P. Mueller, John P. O'Donnell, Seamus O'Brien, Rainard Fuhr, Jean-Yves Gillon

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GARDP Publications

11 December 2025

Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial

Alison Luckey, Manica Balasegaram, Lindley A Barbee, Teresa A Batteiger, Helen Broadhurst, Stephanie E Cohen, Sinead Delany-Moretlwe, Henry J C de Vries

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Fact sheet

Resources

Zolifodacin case study

27 July 2026

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Agreements

Zoliflodacin collaboration agreement overview

Managed Access Program (MAP) for Zoliflodacin

The Zoliflodacin Managed Access Program (MAP) aims to facilitate access to zoliflodacin for the treatment of uncomplicated gonorrhoea in patients with documented ceftriaxone treatment failure or laboratory-confirmed resistance to ceftriaxone, where access is not otherwise available.
Healthcare professionals caring for eligible patients may submit a request through Inceptua, GARDP’s Managed Access Program provider.
For additional information or enquiries regarding the program, please contact MAP-Zoliflodacin@gardp.org.

Access MAP platform

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Zoliflodacin is a first-in-class oral spiropyrimidinetrione antibiotic being developed for patients with uncomplicated gonorrhea, including those infected with multidrug-resistant strains. Because zoliflodacin is metabolized by cytochrome P450 3A4 (CYP3A4), concomitant administration with a CYP3A inhibitor has the potential to increase zoliflodacin plasma exposure. The aim of this phase 1 drug–drug interaction (DDI) study was to assess the effect of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics (PK) and safety of a 3 g single oral dose of zoliflodacin.

Authors

Alison Luckey, Kajal B. Larson, Noha Rayad, Markus Heep, Sophie Delhomme, Gabrielle Kornmann, John P. Mueller, John P. O’Donnell, Seamus O’Brien, Rainard Fuhr, Jean-Yves Gillon

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Sexually-transmitted pathogens Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) cause curable but often asymptomatic bacterial infections. Missed diagnoses and treatment, leading to chronic infections, can cause clinical complications and increase transmission. Accurate prevalence estimates are essential for the effective public health control of these sexually transmitted infections, especially in Africa, where data are scarce.

Authors

Catherine Ngugi,Borna A. Nyaoke,Leonard Kingwara,Pacific Akinyi,Mildred Mmbone,Thaddaeus W. Egondi,George M. Nyangweso,Helen Broadhurst,Gabrielle Kornmann,Rashmi Mathur ,Esther Bettiol

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