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FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries.
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NUZOLVENCE is one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades.
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Gonorrhea affects more than 82 million people worldwide each year and is the second most reported bacterial STI in the United States.1,2
WALTHAM, Mass.--(BUSINESS WIRE)--Dec. 12, 2025-- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), today announced that the U.S. Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. 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 led the Phase 3 clinical trial that supported FDA approval.
“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, M.D., 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 sexually transmitted bacterial infection worldwide, with more than 82 million new cases each year. In the United States alone, the Centers for Disease Control and Prevention (CDC) estimates that over 543,000 cases are reported each year and over 1 million incident cases occur annually,3 underscoring the significant public health impact. The highest rates are seen among sexually active men ages 20-24, though anyone who has unprotected sex can be at risk.4 Without timely treatment, gonorrhea can lead to serious and 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, M.D., 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,” added Dr. Hook.
The emergence and spread of global drug-resistant infections have led the World Health Organization (WHO) to identify antimicrobial resistance as one of the 10 most critical global health threats.5 The bacterium Neisseria gonorrhoeae has developed resistance to most classes of antibiotics used to treat these infections, including cephalosporins such as ceftriaxone, an injectable treatment, which is the currently recommended first line therapy for uncomplicated urogenital gonorrhea.
The Company plans to commercialize NUZOLVENCE in the second half of 2026, either in collaboration with a commercialization partner or independently.
About the Phase 3 Trial
In a pivotal Phase 3, multinational, randomized, controlled, open-label, trial, NUZOLVENCE (zoliflodacin) demonstrated non-inferiority compared to the combination of ceftriaxone plus azithromycin for the treatment of uncomplicated urogenital gonorrhea. NUZOLVENCE was generally well tolerated, and adverse events were comparable between treatment groups. No serious adverse events were reported.
The study enrolled a total of 930 patients, including adolescent and adult participants, to evaluate the efficacy and safety of a single 3g oral dose of zoliflodacin versus a single dose of 500mg intramuscular injection of ceftriaxone plus 1g oral azithromycin for the treatment of uncomplicated gonorrhea. This trial was the largest clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection, with 16 trial sites in regions with a high prevalence of gonorrhea across five countries, including Belgium, the Netherlands, South Africa, Thailand, and the U.S.
About NUZOLVENCE® (zoliflodacin) for oral suspension
NUZOLVENCE is a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. The NUZOLVENCE mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae.
About Innoviva Specialty Therapeutics
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter), and NUZOLVENCE® (zoliflodacin), a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. Through a licensing agreement with Basilea Pharmaceutica, Ltd., Innoviva Specialty Therapeutics retains U.S. marketing rights for ZEVTERA® (ceftobiprole), the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). For more information about Innoviva Specialty Therapeutics, please visit here.
About GARDP
The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public-private partnerships that matter, we develop and make antibiotic treatments accessible to people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. GARDP is registered under the legal name GARDP Foundation. www.gardp.org
About Innoviva
Innoviva, Inc. is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics, and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and NUZOLVENCE® (zoliflodacin), a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, please visit here.
ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA is a trademark of Basilea Pharmaceutica Ltd, Allschwil.
1 World Health Organization (WHO), Multi-drug resistant gonorrhoea fact sheet, 22 October 2025.; https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea#:~:text=Key%20facts,and%2C%20more%20recently%2C%20quinolones.
2 Drug Resistant Gonorrhea; Centers for Disease Control and Prevention 2024; https://www.cdc.gov/gonorrhea/hcp/drug-resistant
3 Centers for Disease Control and Prevention; STI Statistics; Accessed November 14, 2025; https://www.cdc.gov/sti-statistics/annual/index.html
4 Centers for Disease Control and Prevention; 2023 STI Surveillance Report; Page 126, Accessed November 2025; www.cdc.gov/sti-statistics/media/pdfs/2025/09/2023_STI_Surveillance_Report_FINAL_508.pdf
5 Antimicrobial Resistance Collaborators. (2022): Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet; 399(10325): P629-655. DOI: https://doi.org/10.1016/S0140-6736(21)02724-0