Xepi

(Ozenoxacin)

Phase 3Small molecule

LLnhc

Xepi is one of 9 small molecule programs targeting Impetigo. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ImpetigoActive, not recruiting

ImpetigoPhase 3

Active, not recruiting

Competition

Competitive Landscape

16 competitors in Impetigo

#DrugCompanyPhaseTrials

Minocin

Zyvox

1 3

Bactroban

PPadagis LLC

Phase 3

1 4

Fucidin

LEO Pharma

Approved

1 5

Xepi

LLnhc

Phase 3

2 6

Atx201

UUNION therapeutics

Phase 2

1 7

LTX-109

LLytix Biopharma AS

Phase 2

1 8

Topical Minocycline Foam FXFM244

VVyne Therapeutics Inc.

Phase 2

1 9

NVC-422

NNovaBay Pharmaceuticals, Inc.

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Impetigo2 trials

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Completed·FFerrer Internacional S.A.·Phase 3·NCT01397461·465 enrolled

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Completed·FFerrer Internacional S.A.·Phase 3·NCT02090764·412 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 11, 2017

XEPI

NDA NDA208945

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Ozenoxacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ozenoxacin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ozenoxacin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208945). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xepi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Lnhc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: LLnhc

Patent Landscape[5]

Patent Cliff

Dec 15, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9399014Dec 15, 2029

9180200Jan 29, 2032

Xepi

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Impetigo2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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