Thai FDA approves first-in-class oral antibiotic Nuzolvence for gonorrhoea

Dr. Reddy’s, with support from the GARDP Foundation, led the regulatory submissions, while subsidiary Aurigene Pharmaceutical Services played a key role in supporting the product’s development.

Updated - July 27, 2026 11:09 pm IST | HYDERABAD

Thailand’s Food and Drug Administration has approved Nuzolvence (zoliflodacin), a first-in-class oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea. Dr. Reddy’s Laboratories, with support from the GARDP Foundation, led the priority review submission.

Thailand is the second country to approve this new chemical entity. Six months ago, the U.S. Food and Drug Administration had approved the drug. Zoliflodacin was developed through a public-private partnership involving Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc.

“The approval by the Thai FDA is a significant step in providing timely access to an innovative treatment for gonorrhoea, including infections caused by multidrug-resistant strains,” said Deepak Sapra, CEO–API and Services, Dr. Reddy’s.

Key Details

• GARDP holds rights to register and commercialise zoliflodacin in more than three-quarters of the world’s countries, including most low- and middle-income nations.
• Innoviva retains commercial rights in major markets such as North America and the European Union.
• AstraZeneca first identified the NCE that was to become zoliflodacin.

Collaborative Development

The approval reflects collaboration among GARDP, Dr. Reddy’s, and Aurigene Pharmaceutical Services (APSL). While Dr. Reddy’s led the regulatory submissions and engagement with the Thai FDA, subsidiary APSL played an important role in supporting the product’s development.

GARDP’s Deputy Executive Director Peter Beyer said the approval demonstrates the effectiveness of its antibiotic R&D model.

Published - July 27, 2026 11:08 pm IST