Gepirone

Gepirone

Gepirone
Systematic (IUPAC) name
4,4-dimethyl-1-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]piperidine-2,6-dione
Clinical data
Legal status
  • Uncontrolled
Routes Oral
Pharmacokinetic data
Half-life 2-3 hours
Identifiers
CAS number
ATC code N06
PubChem
ChemSpider  YesY
UNII  YesY
ChEMBL  YesY
Chemical data
Formula C19H29N5O2 
Mol. mass 359.46586 g/mol
 YesY   

Gepirone (Ariza, Variza; BMY-13,805, ORG-13,011) is an antidepressant and anxiolytic of the azapirone class. Like other azapirones, it acts as a selective partial agonist of the 5-HT1A receptor. Gepirone was under development in the U.S. in an extended release form, but despite completing phase III clinical trials, it failed to pass the drug approval process. As a result, gepirone, despite already having brand names picked out, did not manage to reach the pharmaceutical market.

Gepirone was originally developed by Bristol-Myers Squibb, but was out-licensed to Fabre-Kramer in 1993. The U.S. Food and Drug Administration (FDA) rejected approval for gepirone in 2004. It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2004. However, in 2007 it once again failed to convince the FDA of its qualities for