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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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大曲貴夫氏は、感染症専門医・医学博士。国立健康危機管理研究機構 危機管理運営局 感染症臨床政策部長、国立国際医療センター副院長および国際感染症センター長を務め、感染症危機管理や災害医療を統括している。

GARDPは、感染症診療、感染予防・制御、健康危機管理を専門とする大曲貴夫氏に、その取り組みと薬剤耐性（AMR）に対する考えについて7つの質問を行いました。

AMRはすでに日本で起きている問題でしょうか？

日本でも深刻な問題として起きています。海外より状況は軽いと言われることもありますが、決してそうではありません。現在、日本では主にMRSA（メチシリン耐性黄色ブドウ球菌）と薬剤耐性大腸菌が問題となっており、これらによる菌血症で年間推計1万人が亡くなっています。AMRは将来の脅威ではなく、すでに日本の医療現場で進行している現実です。

抗菌薬が効かなくなったら、医療はどうなりますか？

医療そのものに大きな影響が出る可能性があります。手術では感染予防のために抗菌薬を使いますが、薬が効かなければ手術自体が難しくなります。がん治療でも、抗がん剤による免疫低下に対応するため抗菌薬が不可欠です。臓器移植など高度医療も同様です。AMRは単に「感染症が治らない」という話ではありません。“医療そのものが成立しなくなる”危機なのです。

なぜ新しい抗菌薬は開発されにくいのでしょうか？

抗菌薬開発は技術的難易度が高く、莫大な費用がかかります。一方で、抗菌薬は高額薬ではなく使用量も限られるため、売上規模が大きくなりにくいという特徴があります。そのため投資回収が難しく、承認取得後に経営破綻した海外企業もあります。こうした構造的な課題があるため、抗菌薬開発を民間企業だけに依存する形では限界があります。

抗菌薬開発のあり方は、どのように変える必要があるでしょうか？

民間企業は収益の確保を前提としていますが、抗菌薬は市場原理だけでは維持しにくい分野です。そのため、政府や公的機関による関与が重要になります。抗菌薬は社会全体の医療を支える“公共財”に近い存在であり、その価値は短期的利益だけでは測れません。

こうした課題に対しては、公的な仕組みや非営利主体も含め、さまざまなステークホルダーが関与しながら、新しい開発やアクセスのあり方そのものを再構築していく動きが進められています。 その中で、GARDPは新しい抗菌薬開発のあり方を実際に示しているモデルの一つだと考えています。目標やアプローチにも共通点が多く、協業の可能性は大きいと感じています。

実際に一緒に取り組むことで、日本においても同様の仕組みを実現できる可能性があり、その結果として研究開発やアクセスの在り方そのものが変わり、より持続可能で強固な体制へと発展していくことも期待できると思います。そういう意味で、日本にとっての利点は非常に大きいのではないかと考えています。 一方で、こうした仕組みを支えるには市民の理解が非常に重要だと思います。

AMRは一国だけで対処できる問題でしょうか？

AMRは国境を越えて広がるため、一国だけで解決できる問題ではありません。薬剤耐性菌の国際的移動は増えており、海外の問題は日本の問題でもあります。治療薬の研究開発においても国際協力は不可欠です。日本は研究力に強みがありますが、臨床試験では国内だけでは十分な数の患者を集められない場合があります。各国がそれぞれの強みを持ち寄ることで、研究開発全体を前進させることができます。こうした観点からも、AMR対策において国際協調は欠かせないものだと思います。

日本にはどのような役割が期待されているのでしょうか？

日本には、国民皆保険制度、感染対策インフラ、安定した医療提供体制という強みがあります。さらに、日本の研究開発力は国際的にも高く評価されています。近年、海外関係者から「日本は逃げないでほしい」と言われることがあります。国際協調が不安定化する中でも、日本は比較的一貫して国際保健分野への関与を続けてきました。その継続性と信頼性に対する期待は大きいと感じています。

一方で、日本の課題は何でしょうか？

最大の課題は、国民の間で危機意識が十分に共有されていないことです。COVID-19やエボラ出血熱の危険性は理解されやすい一方で、AMRの脅威はまだ広く浸透していません。例えば、英国では長年にわたり公的機関による啓発や学校教育が行われてきましたが、日本ではAMRが専門家内部の問題として扱われがちです。しかし本来は社会全体の課題です。

また、自分達自身の反省も含め、研究開発、感染対策、抗菌薬適正使用、アクセス改善、政策、国際協力といった各分野の取り組みが、十分につながっていない印象があります。

バラバラに動くのではなく、ちゃんとゴールを共有して、それぞれの取り組みをつなげていくこと。

それが今、日本では大事だと思います。

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Dr. Norio Ohmagari is an infectious disease specialist and medical doctor. He serves as Director of the Department of Infectious Disease Clinical Policy at the Bureau of Health Security and Management, Specially Appointed Deputy Hospital Director and Director of the Disease Control and Prevention Center of the National Center for Global Health and Medicine in Japan where he oversees infection control, crisis management, and disaster medicine.

GARDP interviewed Dr. Ohmagari, an expert in infectious diseases, infection prevention and control, and health crisis management, about his work and the growing threat of antimicrobial resistance (AMR) globally and in Japan.

Is AMR already a problem in Japan?

Yes, AMR is already a serious problem in Japan. While it is sometimes reported that the situation is less severe than in other countries, this is not the case in reality. Currently, methicillin-resistant Staphylococcus aureus (MRSA) and drug-resistant E. coli are major concerns in Japan, and bloodstream infections caused by these bacteria are estimated to result in around 10,000 deaths annually. AMR is not a future threat—it is a growing problem within Japan’s healthcare system.

What would happen to healthcare if antibiotics stopped working?

It could have a significant impact on medical practice itself. Antibiotics are used to prevent infections during surgery, and if they no longer work, performing surgery becomes extremely difficult. In cancer treatment, antibiotics are essential to manage infections caused by weakened immunity due to chemotherapy. The same applies to advanced medical procedures such as organ transplantation. AMR is not simply a matter of infections becoming untreatable—it represents a crisis in which healthcare itself may cease to function.

Why is it difficult to develop new antibiotics?

Developing antibiotics is technically challenging and requires enormous investment. At the same time, antibiotics are neither high-priced drugs nor widely used, which limits their revenue potential. As a result, companies struggle to recover their investments, and there have even been cases where some have gone bankrupt after obtaining regulatory approval. Because of these structural challenges, relying solely on the private sector for antibiotic development has clear limitations.

How should the approach to antibiotic development be changed?

Private companies operate on the premise of securing profits, but antibiotics is a field that is difficult to sustain under market principles alone. This is why government and public-sector involvement is essential. Antibiotics are akin to a “public good” that underpins healthcare across society, and their value cannot be measured solely in terms of short-term financial returns.

In response to these challenges, efforts are underway involving a range of stakeholders—including public mechanisms and non-profit actors—to fundamentally rethink and redesign how antibiotic development and access are carried out.

Within this broader context, GARDP can be seen as one example that is already demonstrating, in practice, a new approach to antibiotic development. There are many areas where our goals and approaches align, and I believe there is strong potential for collaboration. 

By working together, it may be possible to establish similar mechanisms in Japan, and in doing so, transform how research and development (R&D), and access are structured—ultimately contributing to a more sustainable and resilient healthcare system. In that sense, the potential benefits for Japan could be significant. However, sustaining such systems requires strong public understanding.

Can AMR be addressed by one country alone?

No, it cannot. The spread of drug-resistant bacteria is increasing worldwide, meaning that problems abroad quickly become problems for Japan as well. International collaboration is also essential for R&D. While Japan has strong research capabilities, it may not always be possible to recruit sufficient patient numbers domestically for clinical trials. By bringing together the strengths of different countries, overall progress in R&D can be accelerated. AMR is a challenge that cannot be solved without global cooperation.

What role is Japan expected to play?

Japan has important strengths, including its universal health insurance system, a well-developed infection control infrastructure, and a stable healthcare delivery system. In addition, its R&D capabilities are highly regarded internationally. In recent years, international partners have sometimes said, “We hope Japan will not step back.” Even as global cooperation becomes less stable, Japan has maintained relatively consistent engagement in global health. There are high expectations for its continuity and reliability.

On the other hand, what challenges does Japan face?

The biggest challenge is that a sense of urgency is not yet widely shared among the public. While the risks of COVID-19 and Ebola are easily understood, awareness of the threat posed by AMR has not yet fullyspread. In the United Kingdom, public awareness campaigns and school-based education have been conducted for many years, whereas in Japan, AMR tends to be treated as an issue confined to health experts.

In addition, reflecting our own efforts, activities in R&D, infection prevention, appropriate antibiotic use, expanding access, policy, and international cooperation are not sufficiently interconnected.

Rather than working in silos, it is essential to share common goals and connect these efforts.

This, I believe, is what is most needed in Japan today.

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Striking at the heart of antimicrobial resistance, the international NeoSep 1 trial to evaluate life-saving antibiotic combinations for newborns with sepsis has expanded to India, with the first baby being recruited at the Jawaharlal Postgraduate Education Institute of Medical and Research (JIPMER) in Puducherry.

This was followed by recruiting an infant for the study in Pt. B.D. Sharma PGIMS in Rohtak. The next on the list is Lokmanya Tilak Municipal College and General Hospital, Mumbai. Globally, the study, sponsored by the GARDP Foundation in collaboration with the UCL Innovative Clinical Trials Unit; City St George’s, University of London (SGUL), and Penta Foundation, is also underway in Vietnam and Pakistan, and will soon start in Malaysia, Bangladesh and Uganda.

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