Gepirone hydrochloride ER is under clinical development by Fabre-Kramer Pharmaceuticals and currently in Pre-Registration for Major Depressive Disorder. According to GlobalData, Pre-Registration drugs for Major Depressive Disorder have an 88% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Gepirone hydrochloride ER’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Gepirone hydrochloride ER overview

Gepirone ER is under development for the treatment of major depressive disorder. The drug candidate is administered orally as an extended-release tablet. Gepirone is an analogue of buspirone and act by targeting 5-HT(1A) receptor.

It was also under development for the treatment of generalized anxiety disorder and female hypoactive sexual desire disorder. 

Fabre-Kramer Pharmaceuticals overview

Fabre-Kramer Pharmaceuticals (FKP) is a drug development company that identifies, develops and commercializes psychotropic drugs. The company’s pipeline products include Travivo, FKB01MD, FKW00GA, FKF02SC and FKK01PD. Its products are used for the treatment of various diseases such as central nervous system disorders, anxiety disorder, depression, hypoactive sexual desire disorder, Parkinson’s disease, erectile dysfunction, schizophrenia, social phobia, sexual dysfunction, bipolar disorder, sleep disorder, and others. The company partners with research institutions, pharmaceutical and biotechnology companies. FKP is headquartered in Houston, Texas, the US.

For a complete picture of Gepirone hydrochloride ER’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.