WALTHAM, Mass.–Â Innoviva Specialty Therapeutics, in partnership with the Global Antibiotic Research & Development Partnership (GARDP), announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for zoliflodacin, a first-in-class oral antibiotic designed to treat uncomplicated gonorrhea in adults and adolescents aged 12 and older.
If approved, zoliflodacin would mark the first new antibiotic treatment for gonorrhea in decades, offering a potentially vital tool in the fight against rising antibiotic resistance. Administered as a single oral dose, the drug targets Neisseria gonorrhoeae, including strains that are resistant to multiple existing antibiotics such as ceftriaxone and azithromycin.
“This is a significant step toward providing healthcare providers with an urgently needed oral option to treat gonorrhea, especially infections caused by drug-resistant strains,” said Dr. David Altarac, Chief Medical Officer at Innoviva Specialty Therapeutics. “We are committed to working with the FDA and ensuring that zoliflodacin becomes available to patients as quickly as possible if approved.”
Gonorrhea is the second most common bacterial sexually transmitted infection globally, with more than 82 million new cases reported annually. Without treatment, the infection can lead to severe health consequences, including infertility, pelvic inflammatory disease, and life-threatening ectopic pregnancy.
The FDA’s decision to accept the NDA was based on results from multiple clinical studies, including a pivotal Phase 3 trial that demonstrated zoliflodacin’s effectiveness. The study showed the drug was non-inferior to the current standard treatment—an intramuscular injection of ceftriaxone followed by a week of oral azithromycin—in achieving microbiological cure at the urogenital site. Zoliflodacin was also found to be generally well tolerated, with no serious adverse events or deaths reported.
Zoliflodacin works by inhibiting type II topoisomerase, a bacterial enzyme essential for DNA replication. This unique mechanism has shown promise in overcoming resistance pathways that have rendered many existing treatments ineffective.
The drug has received the FDA’s Qualified Infectious Disease Product (QIDP) designation, granting it Priority Review and extended market exclusivity upon approval.
Dr. Manica Balasegaram, Executive Director of GARDP, emphasized the broader significance of the drug’s development. “This milestone highlights how public-private partnerships can effectively address the global threat of antimicrobial resistance. If approved, zoliflodacin could reach millions of patients around the world who currently lack access to effective treatments.”
While Innoviva affiliate Entasis Therapeutics holds commercial rights for North America, Europe, and the Asia-Pacific region, GARDP will oversee access and distribution in over 75% of countries globally, including all low-income nations and many middle- and high-income countries. GARDP aims to ensure equitable access while promoting responsible use.
With the NDA now under FDA review, Innoviva Specialty Therapeutics anticipates a decision in the coming months that could lead to a long-awaited advancement in the treatment of drug-resistant gonorrhea.
