Brexanolone is under clinical development by Lipocine and currently in Phase III for Post Partum Depression (Maternal Depression / Postnatal Depression). According to GlobalData, Phase III drugs for Post Partum Depression (Maternal Depression / Postnatal Depression) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Brexanolone’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.

Brexanolone overview

Brexanolone is under development for the treatment of postpartum depression (PPD). It is administered through oral route. The drug candidate is a neuro-steroid which acts by targeting gamma-aminobutyric acid type A (GABAA) receptor.

Lipocine overview

Lipocine operates as a pharmaceutical company that develops and commercializes treatments for men’s and women’s health. The company’s pipeline products for men’s health include LPCN 1111, LPCN 1144, LPCN 1021 and for women’s health include LPCN 1107. It’s LPCN 1111 is an oral testosterone product candidate and LPCN 1021 is an oral testosterone replacement therapy with a positive topline. Lipocine offers LPCN 1107, an oral hydroxyprogesterone caproate product for the prevention of preterm birth. LPCN 1144 is a oral prodrug of bioidentical testosterone for the treatment of non alcoholic steatohepatitis. Lipocine is headquartered in Salt Lake City, Utah, US.

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

This content was updated on 10 June 2024

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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.