HQ Team
April 16, 2025: An oral antibiotic, gepotidacin, has shown efficacy in fighting gonorrhoea — one of the most prevalent sexually transmitted infections in the world, according to the results of an end-stage study published in The Lancet.
The gonorrhoea trial involved more than 600 people in five countries with Neisseria Gonorrhoea infections. Gepotidacin was approved last month by the US regulator for treating urinary tract infections.
Researchers found that oral gepotidacin was “non-inferior” to the standard regimen of intramuscular ceftriaxone in combination with azithromycin — with a treatment success rate of 93% and no new safety concerns.
The last new antibiotic for gonorrhoea was introduced in the 1990s.
Ceftriaxone injection
Ceftriaxone injection is the last remaining empiric treatment option for Neisseria Gonorrhoea, a bacterium that has quickly developed resistance to every antibiotic used for treatment.
However, resistance to ceftriaxone is already high in Asia and has been spreading to other parts of the world.
Gonorrhoea is a sexually transmitted infection caused by N. Gonorrhoea. In 2021, the WHO estimated 82·4 million new global gonorrhoea cases among people between 15 and 49 years old. Its prevalence remains high in many low-income and middle-income countries and increasing in many high-income countries.
It can be transmitted through unprotected vaginal, oral, or anal intercourse, and from infected mothers to neonates during delivery.
Most men with gonococcal urethritis are symptomatic, but at least half of women with cervicitis are asymptomatic. Anorectal and oropharyngeal gonorrhoea, mostly asymptomatic, are frequently diagnosed in men who have sex with men, but diagnosis in women is not rare.
Women most affected
Women bear the major burden of disease, with serious complications and sequelae including pelvic inflammatory disease, chronic pelvic pain, disseminated gonococcal infection, ectopic pregnancy, and infertility.
“The potential introduction of a novel oral antibacterial with proven in-vitro activity and in-vivo efficacy would represent a significant advancement in patient care for uncomplicated gonorrhoea,” researchers wrote.
“New oral treatment options, which are often an appealing alternative to parenteral therapy due to their ease of administration, lower health-care resource use, decreased risk of needle-stick injuries, and increased patient satisfaction by avoiding injections, especially in those with needle phobias, are urgently required,” they wrote.
British drugmaker GSK Plc., developed gepotidacin in collaboration with the US government’s Biomedical Advanced Research and Development Authority to combat gonorrhoea.
GSK’s Blujepa
The antibiotic, branded as Blujepa, was approved by the US Food and Drug Administration for uncomplicated urinary tract infections (uUTIs) on March 25.
GSK scientists discovered Blujepa as a part of GSK’s infectious diseases portfolio.
Treatment has been compromised for decades by rapidly evolving and spreading resistance in N. gonorrhoeae, WHO experts wrote in an accompanying commentary in the journal.
“Resistance to the last remaining option for empirical first-line treatment, injectable cephalosporin ceftriaxone, is prevalent in several Asian countries, and ceftriaxone-resistant strains are increasingly confirmed in Europe,” experts Magnus Unemo and Teodora Elvira Wi wrote. “In conclusion, gepotidacin is promising for the treatment of gonorrhoea, but the challenges to retainGonococcal gonorrhoea as a treatable infection will continue.”
Another experimental drug zoliflodacin has demonstrated strong efficacy in fighting stubborn bacterial infections such as gonorrhoea. Zoliflodacin, developed by the Global Antibiotic Research & Development Partnership (GARDP) in collaboration with Entasis Therapeutics, has shown promise.
It employs a unique mechanism to eliminate gonorrhoea bacteria and effectively targets drug-resistant strains.
