Dalzanemdor is under clinical development by Sage Therapeutics and currently in Phase III for Huntington Disease. According to GlobalData, Phase III drugs for Huntington Disease does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Dalzanemdor 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.

Dalzanemdor overview

Dalzanemdor (SAGE-718) is under development for the treatment of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD), Parkinson's disease mild cognitive impairment and Huntington disease. It is administered through oral route in the form of softgel capsule and tablet. SAGE-718 is a 24(S)-hydroxycholesterol, that is a oxysterol-based positive allosteric modulator of NMDA receptor.

It was also under development for cognitive impairment, anti-NMDA receptor encephalitis and cerebrosterol (24S-HC) deficit disorders such as Smith-Lemli-Opitz Syndrome (SLOS) and other indications involving NMDA receptor hypofunction.

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 Dalzanemdor’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 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.