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Zoliflodacin - Entasis Therapeutics

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Drug Profile

Zoliflodacin - Entasis Therapeutics

Alternative Names: AZD-0914; ETX-0914; NUZOLVENCE

Latest Information Update: 16 Dec 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 Type II bacterial DNA topoisomerase 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

  • Registered Gonorrhoea

Most Recent Events

  • 12 Dec 2025 Registered for Gonorrhoea (In adolescents, In the elderly, In adults) in USA (PO) - First global approval
  • 12 Dec 2025 Innoviva plans to launch zoliflodacin for Gonorrhea (PO), in the second half of 2026
  • 12 Jun 2025 FDA assigns PDUFA action date of 15/12/2025 for Zoliflodacin for Gonorrhea

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