Drug Profile

Zoliflodacin - Entasis Therapeutics

Alternative Names: AZD-0914; ETX-0914

Latest Information Update: 22 Jun 2025

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At a glance

Originator AstraZeneca
Developer Entasis Therapeutics; Global Antibiotic Research and Development Partnership
Class Antibacterials; Ketones; Oxazines; Oxazolidinones; Pyrimidines; Quinolines; Small molecules; Spiro compounds
Mechanism of Action DNA gyrase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Highest Development Phases

Preregistration Gonorrhoea

Most Recent Events

12 Jun 2025 FDA assigns PDUFA action date of 15/12/2025 for Zoliflodacin for Gonorrhea
12 Jun 2025 Zoliflodacin receives priority review status for Gonorrhea in USA
10 Jun 2025 Preregistration for Gonorrhoea (In adults, In adolescents, In the elderly) in USA (PO)

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