The Thai Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin), a first-in-class oral antibiotic designed to treat uncomplicated urogenital gonorrhoea in adults and paediatric patients aged 12 years and older weighing at least 35 kg. The approval comes just six months following its initial authorization by the United States Food and Drug Administration (US FDA), making Thailand the second country globally to approve the new chemical entity.
This regulatory milestone was achieved through a priority review submission led by global pharmaceutical company Dr. Reddy’s Laboratories Ltd., with strategic support from the GARDP Foundation (GARDP). The fast-track approval sets a new benchmark for accelerating access to innovative medicines in low- and middle-income countries (LMICs) shortly after high-income market entries. The decision underscores Thailand’s commitment to addressing antimicrobial resistance (AMR) as a national public health priority, particularly as existing antibiotics face rising resistance from Neisseria gonorrhoeae.
Breakthrough Oral Antibiotic for Global Health Priority
With over 82 million new gonorrhoea cases reported globally each year, the introduction of zoliflodacin offers a critical therapeutic alternative for sexually transmitted infections. Developed through a public-private partnership between GARDP and Innoviva Specialty Therapeutics, the drug addresses multidrug-resistant strains without showing cross-resistance to existing antibiotic classes.
“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 regulatory approval was supported by positive data from a pivotal Phase 3 clinical trial sponsored by GARDP, which met its primary endpoint against the standard of care and was published in The Lancet in December 2025. The development journey also built upon initial discovery work by AstraZeneca and a Phase 2 trial sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).
Strategic Partnership and Global Rollout Framework
The authorization process relied on a coordinated framework where Aurigene Pharmaceutical Services Limited (APSL), a subsidiary of Dr. Reddy’s, supported product development while Dr. Reddy’s managed the regulatory strategy with the Thai FDA. Moving forward, GARDP, Dr. Reddy’s, and APSL will collaborate with local healthcare stakeholders to establish commercialization pathways, secure reliable supply chains, and facilitate broad patient access across Thailand.
“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.”
Under licensing agreements, GARDP holds rights to register and commercialize zoliflodacin in more than three-quarters of the world’s countries, focusing on low- and middle-income nations. Meanwhile, Entasis Therapeutics, Inc., an affiliate of Innoviva Specialty Therapeutics, retains commercial rights in major high-income markets, including North America and the European Union. Following Thailand’s approval, GARDP is actively advancing regulatory authorization efforts in South Africa.
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