Thailand's Food and Drug Administration has approved Dr Reddy's first-in-class oral antibiotic NUZOLVENCE (zoliflodacin) for treating uncomplicated urogenital gonorrhoea, making Thailand the second country after the United States to clear the drug. According to reports from Business Standard, the approval comes just six months after the US Food and Drug Administration authorized the medicine, marking one of the fastest roll-outs of a new antibiotic from a developed market to a low- and middle-income country. The Thai FDA approval follows a priority review submission led by Dr Reddy's in November 2025, with the regulatory submission process supported by the Global Antibiotic Research & Development Partnership (GARDP).
The drug is approved for adults and children aged 12 years and older weighing at least 35 kg for the treatment of uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae. As reported by Business Standard, unlike conventional generic launches, zoliflodacin is a new chemical entity developed through a public-private partnership involving GARDP, Innoviva Specialty Therapeutics and Dr Reddy's. The regulatory submission in Thailand was led by Dr Reddy's in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), with Innoviva Specialty Therapeutics serving as the marketing authorisation holder in the United States. The approval is particularly significant given that zoliflodacin was submitted for priority review in Thailand in November 2025, demonstrating the regulatory authority's commitment to expediting access to innovative antibiotics.
The approval is significant as gonorrhoea is becoming increasingly difficult to treat as resistance to existing antibiotics spreads globally. According to the World Health Organization, more than 82 million new gonorrhoea infections occur every year, making antimicrobial resistance (AMR) one of the biggest public health challenges facing healthcare systems. Phase III clinical trial results published in The Lancet on 11 December 2025 showed the drug met its primary efficacy endpoint, while laboratory studies demonstrated activity against multidrug-resistant strains without cross-resistance to existing antibiotics. The findings of this pivotal phase 3 clinical trial were sponsored and led by GARDP, with the trial results published in The Lancet on 11 December 2025.
For Dr Reddy's, the Thai approval could pave the way for wider launches across emerging markets. As reported by Business Standard, GARDP holds the rights to register and commercialise zoliflodacin in more than three-quarters of the world's countries, including most low- and middle-income markets, and is already pursuing regulatory approval in South Africa. Dr Reddy's, together with its subsidiary Aurigene Pharmaceutical Services, will support the commercialisation and supply of the medicine in Thailand, with the commercial opportunity likely to build gradually given that gonorrhoea treatment is typically a single-dose therapy and many markets rely on public health procurement. Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy's, emphasized the company's commitment to making innovative and affordable medicines accessible to patients worldwide, while Peter Beyer, Deputy Executive Director, GARDP, noted that this approval marks a turning point not only for gonorrhoea treatment but for how new antibiotics can be made available globally.
