Brexanolone is under clinical development by Sage Therapeutics and currently in Phase II for Tinnitus. According to GlobalData, Phase II drugs for Tinnitus does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Brexanolone LoA Report. 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 (Zulresso) is a  mixture of allopregnanolone and sulfobutylether-beta-cyclodextrin, acts as an anti-depressant. It is formulated as injectable solution for intravenous route of administration. Zulresso is indicated for the treatment of postpartum depression (PPD) in adults. Zulresso is indicated for the treatment of postpartum depression in patients 15 years of age and older.

SAGE-547 (SGE-120) is under development for the treatment of post-traumatic stress disorder (PTSD), psychosis, tinnitus and alcohol use disorder. The drug candidate is administered through intravenous injection. The drug candidate is a formulation of allopregnanolone, a metabolite of progesterone formed in the CNS. It is a positive GABAA receptor allosteric modulator. The drug candidate is based on positive and negative allosteric modulator (PANAM) chemistry platform. The PANAM technology comprises of non-benzodiazepine approach that regulates allosteric modulation of GABAA receptor in the positive (PAM) direction.

It was also under development for the treatment of postpartum depression (PPD), super-refractory status epilepticus (SE), traumatic brain injury, major depressive disorder, Alzheimer's disease, mild cognitive impairment, COVID-19 related acute respiratory distress syndrome (ARDS) and essential tremor.

Sage Therapeutics overview

Sage Therapeutics (Sage) is a clinical-stage biopharmaceutical company that discovers, develops and markets drugs for the treatment of central nervous system (CNS) disorders. It develops drugs based on selective allosteric modulation of CNS synaptic and extrasynaptic receptors of NMDA and GABA. Its flagship product Zulresso (brexanolone) is a proprietary intravenous (IV) formulation administered for the treatment of postpartum depression (PPD). The company also has various pipeline products for the treatment of indications such as major depressive disorders, bipolar depression, Parkinson’s disease, insomnia, epileptiform disorders, and NMDA hypofunction. The company operates in the US, Bermuda, Germany, Switzerland, Scotland, England and Wales through its subsidiaries. Sage is headquartered in Cambridge, 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 7 February 2024

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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.