In the climate debate, low- and middle-income countries have often been blamed for rising emissions, while the vastly greater historical contribution of wealthy nations is treated as yesterday’s story.

Something similar has happened with the global antimicrobial resistance (AMR) crisis. Low- and middle-income countries (LMICs) have long been portrayed as the worst offenders of antibiotic overuse, with over-the-counter sales and weak regulation seen as one of the main reasons behind the rise and spread of drug-resistant infections. But a new study now challenges this narrative.

Research published in the Lancet Public Health found that overuse is actually concentrated in high-income settings, with these countries consuming the largest volumes of antibiotics used to treat drug-resistant infections. In contrast, many lower-income countries still lack access to these drugs, despite accounting for more than 80% of the estimated global need.

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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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The survey went to all 47 Member States; 25 countries responded (53%). Respondents assessed six antibiotics: amoxicillin, nitrofurantoin, meropenem, vancomycin, ceftazidime-avibactam, and cefiderocol. Findings were discussed in roundtables with country representatives.

The findings show that amoxicillin and nitrofurantoin, both Access antibiotics, were widely seen as priorities. Amoxicillin faced fewer barriers, though some countries highlighted stockouts. Nitrofurantoin access was variable due to limited public sector availability, supply chain issues, and diagnostic constraints. By contrast, countries reported significant access challenges for Watch antibiotics meropenem and vancomycin, with high cost and supply chain issues identified as main barriers. The Reserve antibiotics, ceftazidime-avibactam and cefiderocol, were less recognized as priorities, reflecting unfamiliarity, lack of national registration, high cost, and low public sector availability.

Improving access requires solutions combining regulatory, procurement, and country actions. Suggested actions include rapid appraisals; accelerated registration for Watch and Reserve antibiotics; piloting pooled procurement; and support for country introduction plans including guideline updates, essential medicines list alignment, and prescriber training.

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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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Authors

Susana Ribeiro, Yanina Nuccetelli, Wanda Cornistein, Maria Ines Staneloni

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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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