Trial Profile
A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 24 Sep 2025
Price :
$35
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At a glance
- Drugs Zoliflodacin (Primary) ; Azithromycin; Ceftriaxone
- Indications Gonococcal urethritis; Gonorrhoea
- Focus Registrational; Therapeutic Use
Most Recent Events
- 06 Aug 2025 According to an Innoviva media release, company announced the U.S. Food and Drug Administration (FDA) accepted the zoliflodacin New Drug Application (NDA) for zoliflodacin for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. Company will be working diligently with the FDA toward the PDUFA target action date of December 15, 2025.
- 12 Jun 2025 According to an Innoviva media release, the U.S.FDA has granted Priority Review for the New Drug Application for zoliflodacin, for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act. It is expected the FDA will notify company FDA's decision to conduct an Advisory Committee Meeting in the Day 74 letter.
- 10 Jun 2025 According to an Innoviva media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin,for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.