Gepotidacin

MONDAY, Dec. 15, 2025 — Doctors now have new tools to fight gonorrhea , a common sexually transmitted infection that has grown harder to treat over time. The U.S. Food and Drug Administration (FDA) has approved two new antibiotics: zoliflodacin ( Nuzolvence ) and gepotidacin ( Bluejepa ). This is the first new major treatment for gonorrhea in decades. On Friday, the FDA cleared zoliflodacin, a one-dose pill, after a large clinical trial showed it was safe and effective. Results from that trial were published Dec. 11 in the journal The Lancet . A day earlier, the agency also approved use of gepotidacin , a drug previously approved to treat urinary tract infections in women, to now treat gonorrhea as well. Gonorrhea affects more than 80 million people worldwide each year, according to the World Health Organization (WHO). It is caused by the bacterium Neisseria gonorrhoeae , which has developed resistance to nearly every antibiotic out there. The last new gonorrhea drug, ceftriaxone , was approved in the mid-1980s and is still given as an injection. “Antibiotic resistance is something that keeps all of us up at night so anytime a new antimicrobial comes to market is a cause for celebration,” Dr. Aniruddha Hazra , medical director of the University of Chicago’s Sexual Wellness Clinic, told The New York Times. In the U.S. alone, nearly 600,000 cases of gonorrhea were reported last year, according to the U.S. Centers for Disease Control and Prevention (CDC). About half of infections cause no symptoms, making it easy for the disease to spread without being detected. When symptoms do occur, they can include burning during urination and joint pain. If left untreated, gonorrhea can lead to infertility, blindness in newborns and in rare cases, death. Earlier this year, WHO warned that drug-resistant gonorrhea is spreading in several regions, including the Western Pacific, Africa and Asia. Zoliflodacin was developed through a public-private partnership. The nonprofit Global Antibiotic Research and Development Partnership (GARDP) helped bring the drug to the market after another pharmaceutical company chose not to pursue it. Innoviva Specialty Therapeutics will sell the drug in higher-income countries, while GARDP will help distribute lower-cost versions elsewhere. “The beauty of our model is that we have a stake and skin in the game, and we will exercise those rights to ensure our public health objectives are met,” Dr. Manica Balasegaram , GARDP’s executive director, told The Times . Both new drugs are only approved for gonorrhea infections in genital and urinary tracts, which is intended to maintain their effectiveness. Dr. Edward Hook III , an expert on sexually transmitted infections, said the drug’s single-pill treatment could be a game changer. “This is an important opportunity to expand treatment because no one wants to get a shot,” Hook said. Sources The New York Times, Dec. 12, 2025

On consecutive days, the FDA approved two new oral, first-in-class antibiotics for the treatment of gonorrhea. After a three-decade drought of new antibiotics to treat gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection (STI), which affects more than 80 million people around the world each year. Friday, the U.S. regulator greenlighted Innoviva’s Nuzolvence (zoliflodacin) for uncomplicated urogenital gonorrhea. The nod comes less than 24 hours after the agency granted an approval in the same indication to GSK’s Blujepa, which was already on the market for uncomplicated urinary tract infections following its approval in March.The endorsements are similar in that both therapies are indicated for those ages 12 and older where standard of care treatment is contraindicated or where patients are intolerant or unwilling to use the first line of treatment.While the clearance for Nuzolvence covers patients weighing at least 35 kg (77 pounds), patients must weigh at least 99 pounds to start on Blujepa, according to the FDA..The approvals come at an important juncture as antimicrobial resistance to gonorrhea treatment has been growing. Gonorrhea has been recognized by the World Health Organization and the U.S. Centers for Disease Control and Prevention (CDC) as a priority pathogen and an urgent public threat.The development of Nuzolvence was part of a private, not-for-profit collaboration with the Global Antibiotic Research and Development Partnership (GARDP), which sponsored and conducted the phase 3 clinical trial on which FDA approval was based. “This approval marks a huge turning point in the treatment of multidrug-resistant gonorrhoea, which until now has been outpacing antibiotic development,” Manica Balasegaram, M.D., executive director of the GARDP, said in a release. “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.” The approval for Innoviva comes one day after the company published (PDF) results in The Lancet from a phase 3 trial demonstrating the noninferiority of Nuzolvence to the standard care combination treatment of injected ceftriaxone and oral azithromycin.“A new antibiotic that does not require injection and can be used for patients who are allergic to penicillin or related drugs meets two important unmet needs in the treatment of gonorrhea.," lead trial investigator Edward Hook III, M.D., of the University of Alabama at Birmingham, said in a release. Innoviva asserts that its study of 930 patients is the largest ever conducted for a new treatment against Neisseria gonorrhoeae, the bacteria behind gonorrhea. The program included 16 trial sites in five countries—Belgium, the Netherlands, South Africa, Thailand and the U.S.—in five different global regions where there is a high prevalence of the STI.“As clinicians, we see the devastating impact drug-resistant gonorrhoea can have on people’s lives in Thailand,” Rossaphorn Kittiyaowamarn, M.D., the principal Investigator for Bangrak STI Medical Center, said in a release. “With the number of cases on the rise, there is also huge value in carrying out trials in high-burden countries and among high-burden populations to bring about effective treatment options." If left untreated or inadequately treated, gonorrhea can lead to infertility and other sexual and reproductive health issues. In 2023, there were more than 600,000 cases of gonorrhea in the U.S., according to the CDC, making it the second-most common STI after chlamydia.  For its part, Innoviva traces its roots to 1996, when it was established as a royalty management company called Advanced Medicine. It rebranded with its current name in 2016. Over a span of two months in 2022, the company bought out La Jolla and Entasis and combined them to form a subsidiary, Innoviva Specialty Therapeutics, to commercialize critical care and infectious disease treatments. “The FDA’s approval of Nuzolvence marks a pivotal moment for patients and the broader healthcare community managing gonorrhea infections,” Pavel Raifeld, CEO of Innoviva, said in a statement. “This achievement reflects the strength of our development capabilities and the impact of our collaboration with GARDP and the global scientific community.”