Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc, announced that the U.S. Food and Drug Administration has approved NUZOLVENCE zoliflodacin for oral suspension as a treatment for uncomplicated urogenital gonorrhea. The therapy is approved for adults and adolescents aged 12 years and older who weigh at least 35 kilograms. NUZOLVENCE is the first new class of oral antibiotic approved for gonorrhea in decades and is designed as a single dose treatment, offering a new option for patients and healthcare providers. The drug was developed through a private nonprofit collaboration with the Global Antibiotic Research and Development Partnership, which led and sponsored the Phase 3 clinical trial supporting the FDA decision.
David Altarac, MD, Chief Medical Officer of Innoviva Specialty Therapeutics, said the approval represents a significant advance in the treatment of gonorrhea. He explained that patients and clinicians now have access to a convenient oral therapy that avoids injections and addresses the growing challenge of antibiotic resistance. According to Altarac, the approval highlights Innoviva’s focus on developing new therapies for infectious diseases and reflects the strength of its collaboration with GARDP and the global research community.
Gonorrhea remains one of the most common bacterial sexually transmitted infections worldwide, with tens of millions of new cases reported each year. In the United States alone, hundreds of thousands of cases are diagnosed annually, with actual infections estimated to be much higher. Young adults are disproportionately affected, though anyone engaging in unprotected sex may be at risk. If left untreated, gonorrhea can result in serious health complications, including long term reproductive and systemic issues.
Health Technology Insights: Catalight Chief Clinical Officer Dr. Doreen Samelson Wins 2025 Merit Award
Edward W. Hook III, MD, Professor Emeritus of Medicine at the University of Alabama at Birmingham and lead investigator of the Phase 3 NUZOLVENCE trial, noted that the lack of new gonorrhea treatments over several decades has complicated disease management, especially as resistance to existing antibiotics continues to rise. He stated that in the pivotal clinical trial, NUZOLVENCE performed as well as the current injectable standard of care, including in infections caused by resistant strains, while offering the added benefit of a single oral dose. Dr. Hook also emphasized that an effective oral option is particularly important for patients who cannot tolerate injectable therapies or have allergies to commonly used antibiotics.
The World Health Organization has identified antimicrobial resistance as one of the most serious global health threats. Neisseria gonorrhoeae, the bacterium responsible for gonorrhea, has developed resistance to many antibiotic classes over time, including cephalosporins such as ceftriaxone, which is currently the standard injectable treatment. The approval of NUZOLVENCE introduces a therapy with a novel mechanism of action, helping address this growing resistance challenge.
Health Technology Insights: Innovent Biologics Forms Global Partnership with Takeda
Innoviva plans to bring NUZOLVENCE to market in the second half of 2026, either through a commercial partner or independently. The company believes the new treatment has the potential to significantly change how uncomplicated gonorrhea is managed in clinical practice.
The Phase 3 trial supporting approval was a large multinational study that enrolled 930 adolescent and adult patients across multiple regions with high gonorrhea prevalence. Participants received either a single oral dose of zoliflodacin or the standard injectable therapy combined with oral antibiotics. NUZOLVENCE was generally well tolerated, with safety outcomes comparable between treatment groups and no serious adverse events reported.
NUZOLVENCE is a first in class antibiotic that works through a distinct mechanism targeting bacterial DNA replication. Its demonstrated activity against drug resistant strains positions it as an important new option in the ongoing effort to combat antimicrobial resistance while improving patient convenience and access to care.
Health Technology Insights: Avantor Appoints Sanjeev Mehra to its Board of Directors
To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com
Source- businesswire
