91¿´Æ¬Íø Expertise Helps Deliver Major Breakthrough Antibiotic for Gonorrhoea
- FHS Communications
One of the world’s leading sexually transmitted infections (STIs) is at increasing risk of becoming difficult to control as drug resistance threatens its first-line treatment. Gonorrhoea is a major global health concern, infecting an 82 million people aged 15–49 each year.
For many years, the antimicrobial drug, ceftriaxone, was the only globally recommended treatment for uncomplicated gonorrhoea and was endorsed by the World Health Organization (WHO) in its treatment . However, WHO has raised concerns about a growing trend of ceftriaxone resistance worldwide. This has made gonorrhoea harder and, in some cases, nearly impossible to treat with available medicines.
Gonorrhoea becomes resistant to antibiotics either by changing itself, or by borrowing resistance genes from other bacteria. With the number of infections on the rise, there is great value in conducting trials to develop effective new treatment options.
A recent published in The Lancet. The study focused on zoliflodacin, the first new drug developed specifically for gonorrhoea. The treatment, marketed under the trademark Nuzolvence®, has since been approved by the U.S. Food and Drug Administration for use in adults and adolescents aged 12 and older.
“Gonorrhoea, if untreated, can have a devastating impact, particularly in women, where it can lead to chronic pelvic pain, life-threatening ectopic pregnancies and infertility. 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,” says Professor Sinead Delany‑Moretlwe, 91¿´Æ¬Íø Professor of Global Health and Infectious Diseases and Principal Investigator of the South African leg of the study.
The study evaluated the efficacy and safety of zoliflodacin compared with ceftriaxone, each paired with azithromycin, to determine which treatment could serve as a viable option for uncomplicated urogenital gonorrhoea. Dual therapy with ceftriaxone and azithromycin for gonorrhoea was the standard of care at the time the trial was designed. But since then, several countries have reverted to ceftriaxone monotherapy given the rising resistance of N. gonorrhoeae to azithromycin.
“Since the introduction of antimicrobial treatment of gonorrhoea in the mid-1930s, N. gonorrhoeae has developed by selection of antimicrobial resistance mutations [AMR] or acquired resistance. Consequently, N.gonorrhoeae has evolved resistance to all antimicrobials recommended for empiric monotherapy, with ceftriaxone remaining as the last option for first-line empiric monotherapy,” explains Professor Delany‑Moretlwe.
Phase 3 of the clinical trial was conducted at 17 clinics across Belgium, the Netherlands, South Africa (SA), Thailand, and the United States (USA). The South African part of the study took place at five sites that accounted for 46% of the trial population - almost half of all people who participated in the study.
Professor Delany‑Moretlwe says zoliflodacin is not available in South Africa yet. But there are plans to submit an application for regulatory review and approval to SAHPRA in quarter 1 of 2026.
She emphasises that a single‑dose, oral treatment could be transformative 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,” she adds.