The GARDP Foundation and Dr. Reddy’s Laboratories have 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 pediatric 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. Innoviva Specialty Therapeutics is the marketing authorisation holder in the US.

Zoliflodacin was submitted for Priority Review (PR) in Thailand in November 2025, a process led by the global pharmaceutical company, Dr. Reddy’s Laboratories, with support from GARDP.

The Thai FDA approval comes just 6 months after the drug was initially approved by the US 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 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).

Deepak Sapra, Chief Executive Officer (CEO), API and Services, Dr Reddy’s, said, “As a global pharmaceutical company, Dr. Reddy’s purpose is to make innovative and affordable medicines accessible to patients worldwide. 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 December 11, 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.

Peter Beyer, Deputy Executive Director, GARDP, said, “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. 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.”

GARDP has the right to register and commercialise zoliflodacin in more than three-quarters of the world’s countries, including all LICs and MICs, and several high-income countries (HICs).

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 (EU).

In addition to Thailand, GARDP is taking steps to obtain market authorisation 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.