Wits RHI is proud to share the news that the U.S. FDA has officially approved Nuzolvence® (zoliflodacin), a first-in-class oral antibiotic for uncomplicated urogenital gonorrhoea, co-developed by GARDP and Innoviva Specialty Therapeutics. Zoliflodacin represents the first new treatment in decades developed exclusively for gonorrhoea. It is effective against all tested multidrug-resistant strains of N. gonorrhoeae and shows no cross-resistance to existing therapies. This approval is supported by the largest and most globally diverse Phase 3 gonorrhoea trial, with findings recently published in The Lancet. Wits RHI is proud to have contributed to this result as a participating site under the leadership of Prof Sinead Delany-Moretlwe, Professor of Global Health and Infectious Diseases at Wits University.

“Gonorrhoea can have a devastating impact on women in particular. If untreated, it can lead to infertility, life-threatening ectopic pregnancies and chronic pelvic pain. Added to this, 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. We are very proud to have played a role in this global clinical trial. Having a single-dose, oral treatment like this could be a game changer for gonorrhoea control. This is essential to reduce the burden of disease for people and to prevent the spread of highly drug-resistant gonorrhoea globally.” Professor Sinead Delany-Moretlwe, Director of Research.

This achievement underscores Wits RHI’s commitment to advancing innovative solutions for public health worldwide.

Read the full announcement: GARDP Website. Lancet publication: HERE