A new treatment has been approved against gonorrhea, a sexually transmitted infection (STI) that is increasingly developing resistance to all current antibiotics. 

The US Food and Drug Administration (FDA) approved the use of zoliflodacin to treat uncomplicated gonorrhoea on Friday, following the publication in The Lancet of the results of a phase 3 trial of the new drug, which found that one dose of it was as effective as the current standard treatment.

Uncomplicated urogenital gonorrhea refers to a localised infection of the urethra or cervix that has not spread to other areas of the body.

Each year, over 82 million people are infected with Neisseria gonorrhoeae, but this bacterium has developed resistance to almost all antibiotics, with only one last remaining recommended antibiotic treatment, ceftriaxone. 

But there has been a six-fold increase in resistant infections to ceftriaxone in some countries – particularly Cambodia and Viet Nam – and gonorrhoea was in danger of becoming one of the first diseases to become untreatable due to antimicrobial resistance. 

“This is the first new treatment solely for gonorrhoea in decades and the first to be developed using a novel not-for-profit approach to antibiotic research and development (R&D) aimed at tackling the rise and spread of antimicrobial resistance (AMR),” according to the Global Antibiotic Research & Development Partnership (GARDP).

GARP sponsored the trial of zoliflodacin, which involved 930 participants in five countries – Belgium, the Netherlands, South Africa, Thailand, and the US. 

“This approval marks a huge turning point in the treatment of multidrug-resistant gonorrhoea, which until now has been outpacing antibiotic development,” said GARP executive director Dr Manica Balasegaram. 

“Zoliflodacin shows that a different public-private partnership approach to antibiotic development is possible — one that prioritizes global health needs, strengthens access where the burden is highest, and protects the effectiveness of new drugs for the long-term.” 

Game-changer

“As clinicians, we see the devastating impact drug-resistant gonorrhoea can have on people’s lives in Thailand,” said Dr Rossaphorn Kittiyaowamarn, principal investigator for the trial site in Thailand. 

“Having a single-dose, oral treatment like this will be a game changer for gonorrhoea control. This is essential to reduce the burden of disease for individuals and to prevent the spread of highly drug-resistant gonorrhoea globally.”  

Sinead Delany-Moretlwe, principal investigator for the trial in South Africa, said that gonorrhoea can have a “devastating impact on women in particular”, which, if untreated, “can lead to infertility, life-threatening ectopic pregnancies and chronic pelvic pain”. 

“Babies born to mothers with untreated gonorrhoea may be born prematurely and can develop serious eye infections that can lead to blindness. With the number of gonorrhoea cases on the rise, there is great value in carrying out trials to bring about effective new treatment options,” she added.

Zoliflodacin belongs to a new class of antibiotics, called spiropyrimidinetriones, which has a unique mechanism of action in the way that it inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. 

It is being developed exclusively for the treatment of gonorrhoea, with the hope that this will minimise the likelihood of excessive use, which could contribute to the development of resistance.  

GARDP has the right to register and sell zoliflodacin in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. 

Entasis Therapeutics,, the original license holder and an affiliate of Innoviva Specialty Therapeutics, retains the commercial rights for zoliflodacin in the major markets in North America, EU, and Asia-Pacific. 

Innoviva Specialty Therapeutics will continue to collaborate with GARDP to advance regulatory filings with the European Medicines Agency.

GARDP is also taking steps to obtain market authorisation in Thailand and South Africa as both countries played a key role in the phase 3 trial. 

Zoliflodacin was submitted for priority review in Thailand last month, and a submission in South Africa is planned for early 2026.  

GARDP’s work on zoliflodacin was funded by the governments of Germany, UK, Japan, the Netherlands, Switzerland, Luxembourg, the Canton of Geneva, the South African Medical Research Council (SAMRC), and the Leo Model Foundation.