1. In Vivo

20 Years After First FDA Filing, Gepirone Finally Approaches Depression Market

 
• By Lucie Ellis-Taitt

Private drug developer Fabre-Kramer is expecting approval for its antidepressant gepirone hydrochloride in September 2023. The drug has been rejected multiple times by the FDA as a treatment for major depressive disorder. 

long road
Exxua nears its destination after a long route to market • Source: Shutterstock

This month,Fabre-Kramer Pharmaceuticals’s antidepressant Exxua (gepirone hydrochloride) should finally receive its first regulatory approval, more than 20 years after it was initially rejected by the US Food and Drug Administration.

More than a dozen clinical trials have been conducted and the drug’s development history goes back to the mid-80s. The...

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