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Nuzolvence

(zoliflodacin)

Small molecule

EEntasis Therapeutics

0

Indications

3

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

6

Patents

Clinical

Trials by Indication[1]

TED1 trial

Zoliflodacin in Uncomplicated Gonorrhoea

Completed·GGlobal Antibiotics Research and Development Partnership·Phase 3·NCT03959527·1,011 enrolled

Interaction1 trial

Zoliflodacin Bioequivalence and Drug-Drug Interaction Study

Completed·GGlobal Antibiotics Research and Development Partnership·Phase 1·NCT05635305·50 enrolled

Unspecified1 trial

Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin

Completed·DDrugs for Neglected Diseases·Phase 1·NCT03718806·48 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 12, 2025

NUZOLVENCE

NDA NDA219491

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for zoliflodacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — zoliflodacin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA219491). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Nuzolvence. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Entasis Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: EEntasis Therapeutics

Patent Landscape[4]

Patent Cliff

Oct 13, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9040528Oct 13, 2029

8658641Jun 20, 2030

9839641Jan 21, 2034

9540394Jan 21, 2034

9187495Jan 21, 2034

1 more patents

8889671Jan 21, 2034

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