Innoviva Specialty Therapeutics, a subsidiary of Innoviva, has announced that the US Food and Drug Administration (FDA) has approved the first single-dose oral therapy for urogenital gonorrhea in adults and teenagers.
The approval of NUZOLVENCE (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership (GARDP), which sponsored and led the pivotal Phase 3 clinical trial.
“The FDA’s approval of NUZOLVENCE marks a pivotal moment for patients and the broader healthcare community managing gonorrhea infections. For the first time in decades, both patients and their healthcare providers will have a single-dose, oral treatment option for uncomplicated urogenital gonorrhea,” said David Altarac, Chief Medical Officer, Innoviva Specialty Therapeutics.
“This achievement underscores our commitment to advancing innovative therapies for infectious diseases and fighting antimicrobial resistance. It highlights the strength of our development capabilities, as well as our collaboration with GARDP and the global scientific community.”
Gonorrhea is the second most common bacterial sexually transmitted infection worldwide. Left untreated, gonorrhea can cause serious, potentially permanent health complications.
“The decades-long absence of new gonorrhea treatments, combined with rising global antibiotic resistance, has created significant challenges in managing this common but potentially serious sexually transmitted infection,” said Edward W. Hook III, Professor Emeritus of Medicine, University of Alabama at Birmingham, and lead investigator of the Phase 3 NUZOLVENCE trial.
“In the pivotal Phase 3 study, NUZOLVENCE demonstrated non-inferiority compared to the current standard injectable therapy, including in infections caused by drug-resistant strains, while offering the convenience of a single oral dose.”
“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,” Dr Hook added.
The World Health Organization lists antimicrobial resistance as one of the 10 most critical global health threats, with Neisseria gonorrhoeae—gonorrhea’s bacterial culprit—resistant to most commonly used antibiotics, including the injectable ceftriaxone, the current first-line therapy.
Innoviva plans to commercialize NUZOLVENCE in the second half of 2026, either independently or in partnership.
The multinational, randomized, open-label Phase 3 trial enrolled 930 adolescent and adult participants across 16 sites in five countries, including Belgium, the Netherlands, South Africa, Thailand, and the US.
NUZOLVENCE, administered as a single 3g oral dose, was non-inferior to the combination of 500 mg ceftriaxone injection plus 1g oral azithromycin. The drug was generally well tolerated, with adverse events comparable to standard therapy and no serious adverse events reported.
This trial represents the largest clinical study ever conducted for a new gonorrhea treatment, paving the way for the first convenient, oral single-dose option in decades.
