Drugs / Gepirone
last change Jan 2026 re-read 3 minutes ago

Gepirone

Small molecule targets HTR1A via activation

Developed for
cocaine dependence
Investigated by
National Institute on Drug Abuse (NIDA) · University of Pennsylvania

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) EXXUA — 2023-09-22 fda.gov ↗

Trials 1

today
US approved 2023
NCT00000189 · Ph 2
198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT00000189 Jan 1990 → Feb 1991 cocaine dependence University of Pennsylvania Completed No outcome recorded

Press releases naming this drug 8 releases

DateIssuerRelease
2026-01-20 Aytu BioPharma, Inc. Aytu BioPharma Highlights Opportunity for EXXUATM (gepirone) as New Way to Treat Major Depressive Disorder That Avoids Common Side Effects of Sexual Dysfunction and Significant Weight Gain following launch of EXXUA aytubio.com ↗
2025-12-15 Aytu BioPharma, Inc. Aytu BioPharma Announces Commercial Availability of EXXUA(TM) (gepirone) Extended-Release Tablets, the First and Only 5HT1a Agonist Indicated for the Treatment of Major Depressive Disorder in Adults aytubio.com ↗
2025-10-28 Aytu BioPharma, Inc. Aytu BioPharma Announces Patent Term Extension for EXXUA(TM) aytubio.com ↗
2025-09-23 Aytu BioPharma, Inc. Aytu BioPharma Reports Fiscal 2025 Full Year and Fourth Quarter Operational and Financial Results and Outlines Commercial Launch Plans for EXXUA(TM) aytubio.com ↗
2025-06-25 Aytu BioPharma, Inc. Aytu BioPharma Appoints Dr. Gerwin Westfield as Senior Vice President of Scientific Affairs to Support Commercialization of EXXUA(TM) aytubio.com ↗
2025-06-23 Aytu BioPharma, Inc. Aytu BioPharma Expands and Extends Lending Agreement with Eclipse Following Agreement to Commercialize First-in-Class Antidepressant EXXUA(TM) aytubio.com ↗
2025-06-09 Aytu BioPharma, Inc. Aytu BioPharma Announces Closing of Upsized At the Market Public Offering of Common Stock with Full Exercise of Overallotment and Conference Call to Discuss First-in-Class Antidepressant EXXUA(TM) Opportunity and Commercialization Plan aytubio.com ↗
2025-06-06 Aytu BioPharma, Inc. Aytu BioPharma Announces Exclusive Agreement with Fabre-Kramer Pharmaceuticals to Commercialize First-in-Class Antidepressant EXXUA(TM) (gepirone) Extended-Release Tablets in the United States aytubio.com ↗

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Gepirone ClinicalTrials.gov intervention name — accepted as the source's own label NCT00000189 ↗
Known as Ariza ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as BMY 13805-1 ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as BMY-13805 ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as Exxua ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as Gepirona ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as Gepirone hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as GEPIRONE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as Mj-13805 ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as ORG 33062 ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as ORG-33062 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as TGFK07AD ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as Travivo ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Known as Variza ChEMBL registry synonym — accepted as the source's own label CHEMBL284092 ↗
Action Activate “Serotonin 1a (5-HT1a) receptor agonist” CHEMBL284092 ↗
Modality Small molecule — CHEMBL284092 ↗
Target HTR1A “Serotonin 1a (5-HT1a) receptor agonist” CHEMBL284092 ↗