Zuranolone is under clinical development by Sage Therapeutics and currently in Phase II for Bipolar Disorder (Manic Depression). According to GlobalData, Phase II drugs for Bipolar Disorder (Manic Depression) have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Zuranolone’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.

Zuranolone overview

Zuranolone (Zurzuvae) is a neuroactive steroid gamma-aminobutyric acid (GABA) positive modulator receptor. It is formulated as capsules for the oral route of administration. Zurzuvae is indicated for the treatment of postpartum depression (PPD) in adults.

Zuranolone (SAGE-217, SAGE-NCE) is under development for the treatment of postpartum depression, bipolar disorder, major depressive disorder, treatment resistant depression and generalized anxiety disorder. It is administered through oral route in the form of capsule or solution. It is a new chemical entity (NCE) that targets GABAA receptor. SAGE-NCE is developed based on positive and negative allosteric modulator (PANAM) chemistry platform.

It was also under development as an intravenous therapy for refractory status epilepticus (RSE) and as an oral therapy for orphan genetic epilepsy disorders, such as Dravet syndrome, Rett syndrome and Fragile X syndromes. The drug candidate was also under development for essential tremors, dyskinesias, insomnia and Parkinson’s disease.

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 Zuranolone’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.