Lumateperone tosylate is under clinical development by Intra-Cellular Therapies and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lumateperone tosylate’s likelihood of approval (LoA) and phase transition for Bipolar I Disorder took place on 20 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lumateperone tosylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Lumateperone tosylate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Lumateperone tosylate
Administration Pathway
  • Oral
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
Key Developers
Highest Development Stage
  • Marketed

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.