Gepirone

Gepirone (INN) (developmental code names BMY-13805, MJ-13805, ORG-13011, TGFK07AD; proposed brand names Ariza, Variza) or gepirone hydrochloride (USAN) is an antidepressant and anxiolytic drug of the azapirone group that has never been marketed. Like other azapirones, it acts as a selective partial agonist of the 5-HT_1A 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 chosen, 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 treating anxiety and depression. In December 2015, the FDA once again gave gepirone a negative review for depression due to concerns of efficacy.