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.

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Data Insights Likelihood of Approval and Phase Transition Success Rate Model - Lumateperone Tosylate in Schizoaffective Disorder

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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.

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, 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, Schizoaffective Disorder, insomnia and autism spectrum disorders (pervasive developmental disorder (PDD)).

Intra-Cellular Therapies overview

Intra-Cellular Therapies (ICTI) is a biopharmaceutical company that discovers, develops, and commercializes small molecule drugs that address underserved medical needs primarily in neuropsychiatric and neurological disorders. The company pipeline includes lumateperone for major depressive disorder and bipolar depression; TI-1284-ODT-SL for the treatment of agitation and psychosis in patients with Alzheimer’s; ITI-1500 series ITI-1549. 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 12 April 2024

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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.