Lumateperone tosylate is under clinical development by Intra-Cellular Therapies and currently in Phase III for Bipolar I Disorder. According to GlobalData, Phase III drugs for Bipolar I Disorder 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 Lumateperone tosylate LoA Report. 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, and unspecified psychiatric disorders. The drug candidate is administered orally as a capsule or powder for solution 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 and autism spectrum disorders (pervasive developmental disorder (PDD)).

Intra-Cellular Therapies overview

Intra-Cellular Therapies (ICTI) is a biopharmaceutical company that discovers and develops and commercialization of small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders. The company pipeline includes lumateperone for the treatment of major depressive disorder and bipolar depression and TI-1284-ODT-SL for the treatment of agitation and psychosis in patients with Alzheimer’s. ICTI’s other pipeline includes PDE inhibitor for Parkinson’s and cancer immunotherapy and ITI-333 for opioid use disorder, pain and mood disorders. It also utilizes CNSProfile, a technology platform that monitors the phosphoprotein changes elicited by major psychotropic drug classes and subclasses and generates a unique molecular signature for drug compounds. ICTI is headquartered in New York, the US.

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

This content was updated on 20 May 2024

Premium Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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.