ITI-1284 is under clinical development by Intra-Cellular Therapies and currently in Phase I for Psychosis. According to GlobalData, Phase I drugs for Psychosis have a 59% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how ITI-1284’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.

ITI-1284 overview

Deuterated lumateperone (ITI- 1284) is under development for the treatment of behavioural disturbances in dementia, dementia-related psychosis, agitation in patients with probable Alzheimer’s disease (AD), generalized anxiety disorders and certain depressive disorders in the elderly. It is a deuterated form of lumateperone, a new molecular entity formulated as an orally disintegrating tablet for sublingual administration. It targets 5-hydroxytryptamine receptor 2A (5 HT2A), D2 receptor and the serotonin transporter. It is being developed based on Zydis ODT (orally disintegrating tablet) fast-dissolving formulation.

Intra-Cellular Therapies overview

Intra-Cellular Therapies (ICTI) carries out the discovery, clinical development and commercialization of innovative, small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system. The company develops drugs for the treatment of heart failure, immune system regulation, neurodegenerative diseases, cancers and other non-CNS disorders. Its pipeline products include lumateperone (ITI-007) which is used for the treatment of schizophrenia, behavioral disturbances associated with dementia and Alzheimer’s disease, bipolar disorder and behavioral disturbances such as dementia and Alzheimer’s disease. ICTI is headquartered in New York City, New York, the US.

For a complete picture of ITI-1284’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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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.