Brexanolone is under clinical development by Puretech Health and currently in Phase II for Sleep Disorders. According to GlobalData, Phase II drugs for Sleep Disorders have a 49% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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.

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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 neurological and neuropsychological conditions, including major depression disorder (MDD) with anxiety, sleep disorders, fragile X tremor-associated syndrome, essential tremor, epileptic disorders, postpartum depression, among others. It is administered by oral route. It acts by targeting GABAA receptor. The drug candidate is developed based on Glyph technology.

Puretech Health overview

Puretech Health (Puretech), a subsidiary of Royalty Pharma Plc, is a biotherapeutics company that discovers, develops, and commercializes drugs to treat lung dysfunction, immuno-oncology, lymphatic, neurological and neuropsychological disorders. The company is pipeline products include LYT-100 (deupirfenidone), targeting inflammation and fibrosis, lymphedema, and SARS-CoV-2 respiratory problems; LYT-200, a human monoclonal antibody for the treatment of pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC) and cholangiocarcinoma (CCA); and LYT-210, a gamma delta-1 T cell receptor against solid tumors. It is also evaluating LYT-300, oral allopregnanolone for neurological indications. Puretech works in collaboration with pharmaceutical and biotechnology companies to develop its products. Puretech is headquartered in Boston, Massachusetts, the US.

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

This content was updated on 18 March 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.