FDA Accepts Innoviva's Application for Zoliflodacin, a Novel Oral Gonorrhea Antibiotic

WALTHAM, MA, USA & GENEVA, Switzerland, June 10, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., has announced a significant stride in combating antibiotic-resistant infections: the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for zoliflodacin. This groundbreaking oral antibiotic, developed in partnership with the Global Antibiotic Research & Development Partnership (GARDP), is designed to treat uncomplicated gonorrhea in patients aged 12 and older. If approved, zoliflodacin would become the first novel antibiotic for gonorrhea treatment in several decades.

Gonorrhea, a widespread sexually transmitted infection, affects over 82 million people globally each year. It ranks as the second most prevalent bacterial STI, impacting both men and women. Untreated, it can lead to severe health issues, including infertility in women and life-threatening conditions like ectopic pregnancy. The urgent need for new treatments has grown as Neisseria gonorrhoeae, the bacterium responsible for gonorrhea, has increasingly developed resistance to existing antibiotics, such as ceftriaxone, which has been a standard treatment since 1984.

David Altarac, M.D., Chief Medical Officer of Innoviva Specialty Therapeutics, expressed optimism about the FDA's acceptance of the NDA, seeing it as a major advancement towards introducing a new oral treatment option for gonorrhea, particularly strains resistant to current drugs. He emphasized the commitment to working with the FDA to expedite zoliflodacin's availability to patients across the United States. This development aligns with recent findings in The Lancet Infectious Diseases, highlighting the rise of ceftriaxone-resistant gonorrhea strains, which underscores the need for new antibiotics to manage the disease effectively and prevent its spread.

The NDA submission was supported by extensive data from multiple clinical trials conducted through a collaborative effort with GARDP. Among these was a pivotal Phase 3 trial, which demonstrated zoliflodacin's effectiveness in achieving microbiological cure rates comparable to the conventional treatment involving ceftriaxone and azithromycin. The study also revealed zoliflodacin to be generally well-tolerated, with no severe adverse effects reported.

Dr. Manica Balasegaram, Executive Director at GARDP, highlighted the importance of such collaborations in addressing the global crisis of antimicrobial resistance. If approved, zoliflodacin could provide a powerful weapon against multidrug-resistant gonorrhea, offering hope to millions worldwide who require effective treatment for this condition.

Zoliflodacin operates through a unique mechanism that inhibits type II topoisomerase, a vital bacterial enzyme necessary for bacterial reproduction. Laboratory studies have shown its effectiveness against strains resistant to both ceftriaxone and azithromycin, without showing cross-resistance to other antibiotics. Administered as a single oral dose, it offers a convenient treatment alternative for those unable to receive intramuscular injections.

The FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation, which facilitates Priority Review and Extended Market Exclusivity. Innoviva Specialty Therapeutics anticipates a standard review process under this designation. Entasis Therapeutics, affiliated with Innoviva, retains commercial rights for zoliflodacin in key markets across North America, Europe, and Asia-Pacific. Meanwhile, GARDP holds the rights to launch and commercialize the drug in over three-quarters of the world's countries, including low and middle-income regions, working with health authorities to ensure access and appropriate use of the treatment.

This initiative reflects the broader goals of both Innoviva and GARDP to develop new treatments that address critical public health challenges posed by drug-resistant infections, ensuring these solutions reach those most in need.