Lumateperone tosylate is under clinical development by Intra-Cellular Therapies and currently in Phase I for Schizoaffective Disorder. According to GlobalData, Phase I drugs for Schizoaffective Disorder have a 75% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Lumateperone tosylate’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.

Lumateperone tosylate overview

Lumateperone tosylate (Caplyta) is a butyrophenone antipsychotic agent. Caplyta is formulated as hard gelatin capsules for oral route of administration. Caplyta is indicated for the treatment of schizophrenia in adults. Lumateperone tosylate (ITI-007) is under development for the treatment of schizophrenia, schizoaffective disorders, mental illness, sleep disturbances associated with neuro-psychiatric disorders and other neuro-psychiatric conditions including major depressive disorders associated with bipolar I or bipolar II disorders, autism spectrum disorders (pervasive developmental disorder (PDD)) and unspecified psychiatric disorders. The drug candidate is administered orally as a capsule or powder for solution and subcutaneous route. It acts by targeting 5HT2A receptor. It was also under development for the treatment of agitation in patients with dementia, including Alzheimer's disease.

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 Lumateperone tosylate’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.