ITI-1284 is under clinical development by Intra-Cellular Therapies and currently in Phase II for Generalized Anxiety Disorder (GAD). According to GlobalData, Phase II drugs for Generalized Anxiety Disorder (GAD) have a 52% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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) 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 ITI-1284’s drug-specific PTSR and LoA scores, buy the report here.
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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.
