Thai FDA Approves Dr Reddy’s New Gonorrhoea Drug Zoliflodacin
Hyderabad, July 27 (TNT): The Thai Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin), a first-in-class oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea, marking the second global approval for the drug after the United States, GARDP Foundation and Dr. Reddy’s Laboratories announced on Monday.
The approval follows a priority review submission led by Hyderabad-based Dr. Reddy’s Laboratories, with support from the Global Antibiotic Research & Development Partnership (GARDP).
NUZOLVENCE is indicated for the treatment of uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae in adults and paediatric patients aged 12 years and above weighing at least 35 kg.
The drug was developed through a public-private research and development partnership between GARDP and Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc.
Dr. Reddy’s led the regulatory submission for priority review in Thailand after filing the application in November 2025.
The approval comes six months after the United States Food and Drug Administration (US FDA) approved zoliflodacin, making Thailand the second country to clear the new chemical entity.
The companies said the development demonstrates that innovative medicines can reach low- and middle-income countries much sooner after their first approval in high-income markets.
The approval assumes significance amid growing antimicrobial resistance (AMR), which has made gonorrhoea increasingly difficult to treat with existing antibiotics.
More than 82 million new gonorrhoea infections occur globally each year, underscoring the need for new treatment options.
The approval follows a pivotal Phase III clinical trial sponsored and led by GARDP, which met its primary objective against the current global standard of care.
Earlier in-vitro studies also showed zoliflodacin to be effective against multidrug-resistant strains of Neisseria gonorrhoeae, with no cross-resistance to existing antibiotics.
Commenting on the development, Dr. Reddy’s Chief Executive Officer (API and Services) Deepak Sapra said the approval was a significant step towards ensuring timely access to an innovative treatment for gonorrhoea, including multidrug-resistant infections, while demonstrating a new paradigm for providing breakthrough medicines to patients in low- and middle-income countries.
GARDP Deputy Executive Director Peter Beyer said the approval marked a turning point not only in the treatment of gonorrhoea but also in making new antibiotics available globally, validating GARDP’s product development partnership model.
Dr. Reddy’s Laboratories, GARDP and Aurigene Pharmaceutical Services Limited (APSL) said they would continue working with healthcare stakeholders in Thailand to support commercialisation, ensure reliable supply and facilitate broad patient access to the new treatment.
GARDP is also pursuing market authorisation for zoliflodacin in South Africa as part of its global access strategy.
TNT TS
