Exxua

(Gepirone)

Phase 2Small molecule

PPierre Fabre Medicament

Exxua is one of 52 small molecule programs targeting Cocaine Dependence. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cocaine DependenceActive, not recruiting

Cocaine DependencePhase 2

Active, not recruiting

Competition

Competitive Landscape

101 competitors in Cocaine Dependence

#DrugCompanyPhaseTrials

Permax

VValeant Pharmaceuticals

Phase 3

1 2

Bupropion XL

GSK

Phase 3

1 3

Celexa

AbbVie

Phase 2

3 4

Ritalin

Novartis

Phase 2

2 5

Buspar

Bristol-Myers Squibb

Phase 2

2 6

Tegretol

Novartis

Phase 2

2 7

Dostinex

Pfizer

Phase 2

2 8

Sabril

Lundbeck

Phase 2

2 9

Lioresal

Novartis

Phase 2

1 10

Aricept

Eisai

Phase 2

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

Clinical

Trials by Indication[1]

Cocaine Dependence1 trial

Gepirone vs Placebo in Treatment of Cocaine Dependence - 3

Completed·UUniversity of Pennsylvania·Phase 2·NCT00000189·41 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 22, 2023

EXXUA

NDA NDA021164

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Gepirone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gepirone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gepirone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021164). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Exxua. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pierre Fabre Medicament company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: PPierre Fabre Medicament

Patent Landscape[5]

Patent Cliff

Sep 2, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7538116Sep 2, 2030

Exxua

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Cocaine Dependence1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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