Hyderabad: Thailand’s drug regulator has approved Nuzolvence (zoliflodacin), a first-in-class oral antibiotic for uncomplicated urogenital gonorrhoea, making Thailand the second country to authorise the treatment just six months after its US approval, Global Antibiotic Research and Development Partnership (GARDP) and Dr Reddy’s Laboratories said Monday.The Thai Food and Drug Administration cleared the medicine for adults and paediatric patients aged 12 and older who weigh at least 35 kg and have uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae.Dr Reddy’s led the priority review submission, filed in Nov 2025, with support from the GARDP.The partners said the decision sets a benchmark for accelerating access to innovative antibiotics in low- and middle-income countries soon after initial high-income market approvals.Thailand’s approval also comes amid rising antimicrobial resistance, which has made gonorrhoea increasingly difficult to treat. More than 82 million new gonorrhoea infections occur globally each year.Zoliflodacin was developed through a public-private research partnership involving GARDP and Innoviva Specialty Therapeutics, the US marketing authorisation holder.A pivotal phase 3 trial sponsored by GARDP met its primary objective against the current global standard of care, with results published in The Lancet in Dec 2025.Earlier laboratory studies showed activity against tested multidrug-resistant N. gonorrhoeae strains and no cross-resistance with other antibiotics.Dr Reddy’s CEO for API and services Deepak Sapra said the Thai authorisation shows patients in lower-resource markets can receive breakthrough medicines within months, not years.GARDP’s deputy executive director Peter Beyer called the approval proof that partnership-based antibiotic development can advance access where commercial markets remain unattractive globally.
