FDA accepts NDA for zoliflodacin to treat gonorrhea
As strains of antibiotic-resistant gonorrhea spread, zoliflodacin provides an alternative oral treatment with non-inferiority to other methods.
FDA accepts NDA for zoliflodacin to treat gonorrhea | Image Credit: © Tada Images - © Tada Images - stock.adobe.com.
The FDA has accepted a New Drug Application (NDA) for zoliflodacin as a treatment against uncomplicated gonorrhea in patients aged at least 12 years, according to Innoviva Specialty Therapeutics, Inc.1
Using Zoliflodacin to treat uncomplicated gonorrhea
This acceptance occurred following data from multiple clinical trials highlighting the efficacy of zoliflodacin as a single-dose treatment in pediatric and adult patients with uncomplicated gonorrhea. If approved, it will be the first new oral antibiotic for gonorrhea management in decades, according to the company.
“Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, MD, chief medical officer of Innoviva Specialty Therapeutics.
Gonorrhea as a growing global threat
Gonorrhea has been reported as the second most common bacterial sexually transmitted infection, with over 82 million new cases worldwide annually. Patients may face severe adverse health outcomes from untreated gonorrhea.
Additionally, drug-resistant infections have become more prevalent, listed as one of the 10 most critical public health threats globally by the World Health Organization. This includes resistance from the bacterium Neisseria gonorrhoeae against multiple antibiotics, such as the intramuscular injection ceftriaxone, which was made available in 1984.
Zoliflodacin’s efficacy and safety
Innoviva Specialty Therapeutics obtained clinical data for zoliflodacin in clinical trials conducted in partnership with the Global Antibiotic Research & Development Partnership. This includes a phase 3 clinical trial comparing the drug as a single oral dose vs an intramuscular injection of ceftriaxone followed by oral azithromycin administration for 1 week.
The former regimen demonstrated non-inferiority in achieving microbiological cure at the infection site compared to the latter. Tolerance was also reported, with no patients experiencing severe adverse events or death.
Mechanism of action
Zolifodacin uses type 2 topoisomerase, a vital bacterial enzyme for bacterial function and reproduction. It has displayed activity against Neisseria gonorrhoeae strains presenting with multi-drug resistance. This includes strains resistant to ceftriaxone and azithromycin.
As an oral alternative to intramuscular injection, zolifodacin simplifies uncomplicated gonorrhea treatment. Alongside the NDA acceptance, the FDA has granted the drug a Qualified Infectious Disease Product designation, allowing it to benefit from FDA Priority Review and Extended Market Exclusivity.
Global resistance trends highlight urgency for new antibiotics
The need for new antibiotics has been highlighted by a report in The Lancet Infectious Diseases, which reported increasing isolates with high minimum inhibitory concentrations (MICs) to cephalosporin antibiotics.2 According to the report, elevated ceftriaxone MIC values have been reported in Neisseria gonorrhoeae strains across multiple countries.
The report surveyed antimicrobial resistance using standardized methods. Specimens were obtained from Cambodia, where a single 400 mg oral dose of cefixime is used for treatment. After obtaining samples, investigators isolated Neisseria gonorrhoeae from 93 urethral specimens.
Of viable isolates, 38% presented with ceftriaxone MIC values of at least 0·125mg/L. All of these isolates displayed resistance to penicillin, ciprofloxacin, and cefixime. Additionally, extensive drug resistance was reported in 4% of isolates, with high-level azithromycin co-resistance.
“This report confirms the urgent need for ongoing and expanded enhanced culture-based antimicrobial resistance surveillance and shows the usefulness of genomic sequencing to enhance our understanding of antimicrobial resistance evolution and spread,” wrote investigators.
References
- Innoviva Specialty Therapeutics receives FDA New Drug Application acceptance for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in adults. Business Wire. June 10, 2025. Accessed June 10, 2025. https://www.businesswire.com/news/home/20250610102070/en/Innoviva-Specialty-Therapeutics-Receives-FDA-New-Drug-Application-Acceptance-for-Zoliflodacin-a-First-in-Class-Oral-Antibiotic-for-Uncomplicated-Gonorrhea-in-Adults.
- Ouk V, Dinh Pham C, Wi T, van Hal SJ, Lahra MM, EGASP Cambodia working group. The Enhanced Gonococcal Surveillance Programme, Cambodia. The Lancet Infectious Disease. 2023. doi:10.1016/S1473-3099(23)00479-6
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