Zuranolone is under clinical development by Sage Therapeutics and currently in Pre-Registration for Major Depressive Disorder. According to GlobalData, Pre-Registration drugs for Major Depressive Disorder have an 89% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. 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 (SAGE-217, SAGE-NCE) is under development for the treatment of postpartum depression, bipolar disorder, major depressive disorder and generalized anxiety disorder. It is administered by the oral route. 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, 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.


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.