Intra-Cellular Therapies Inc.

ITCI

Held by 7 specialist biotech funds

High Convergence

7 funds opened new positions. Next phase2 readout (ITI-007): Jul 2015.

Drug Manufacturers - Specialty & GenericCEO: Sharon MatesIPO: 2014Website ↗

Intra-Cellular Therapies, Inc., a biopharmaceutical company, develops novel drugs for the treatment of neuropsychiatric and neurologic diseases by targeting intracellular signaling mechanisms within the central nervous system in the United States. The company offers CAPLYTA for the treatment of schizophrenia in adults. It is also involved in developing lumateperone, which is in Phase III clinical trial for the treatment of bipolar depression, as well as to treat autism spectrum disorder; and in additional neuropsychiatric indications, such as sleep disorders associated with neuropsychiatric and neurological disorders. In addition, the company is developing Lenrispodun (ITI-214) for the treatment of Parkinson's disease and heart failure; ITI-1284-ODT-SL for the treatment of neuropsychiatric disorders and behavioral disturbances in dementia; and ITI-333 for substance use disorders, pain, and psychiatric comorbidities, including depression and anxiety. Intra-Cellular Therapies, Inc. was founded in 2002 and is headquartered in New York, New York.

Catalysts

Phase 2Q3 2014ITI-007Alzheimer's DiseaseNCT02078310

Primary: Number of participants with adverse events (up to 7 days)Enrollment:35/35Sites: 1RANDOMIZED, QUADRUPLE, BASIC_SCIENCE

Phase 2PositiveQ3 2015ITI-007SchizophreniaNCT02288845

Primary: Brain Receptor Occupancy as Measured by Positron Emission Tomography (Up to 14 days)Enrollment:14/14Sites: 1NA, BASIC_SCIENCE

Phase 3PositiveQ3 2015ITI-007SchizophreniaNCT02282761

Primary: Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score (28 days)Enrollment:450/450Sites: 11RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2016ITI-007SchizophreniaNCT02469155

Primary: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (6 weeks)Enrollment:696/696Sites: 11RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2019ITI-007 (Lumateperone)Bipolar DepressionNCT02600494

Primary: Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (6 weeks)Enrollment:554/554Sites: 55RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ1 2019ITI-007Agitation in Dementia, Including Alzheimer's DiseaseNCT02817906

Primary: Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) (4 weeks (28 Days))Enrollment:177/177Sites: 26RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2019LumateperoneBipolar DepressionNCT03249376

Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline to Day 43)Enrollment:381/381Sites: 47RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2020ITI-214Heart Failure, SystolicNCT03387215

Primary: Echocardiogram with Doppler imaging and hemodynamic monitoring (2 hours)Enrollment:36/36Sites: 2RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2020Lumateperone (ITI-007)Bipolar DepressionNCT02600507

Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (Baseline to Day 43)Enrollment:529/529Sites: 71RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2022LumateperoneBipolar Depression, Major Depressive DisorderNCT04285515

Phase 3PositiveQ1 2024LumateperoneMajor Depressive DisorderNCT04985942

Phase 3PositiveQ2 2024LumateperoneMajor Depressive DisorderNCT05061706

Phase 3Q3 2024Lumateperone 42 mgSchizophreniaNCT04959032

Phase 3PositiveQ4 2024LumateperoneMajor Depressive DisorderNCT05061719

Phase 2Q3 2025LenrispodunParkinson DiseaseNCT05766813

Phase 3Q1 2026LumateperoneBipolar Disorder, ManicNCT06462586

Phase 3Q2 2026LumateperoneBipolar Disorder, ManicNCT06462612

Phase 3Q3 2026LumateperoneMajor Depressive DisorderNCT05850689

Phase 3Q1 2027Lumateperone high doseIrritability Associated With Autism Spectrum DisorderNCT06706674

Phase 3Q1 2027Lumateperone high doseIrritability Associated With Autism Spectrum DisorderNCT06690398

Phase 3Q2 2027LumateperoneBipolar DepressionNCT06372964

Phase 2Q2 2027ITI-1284 10 mgGeneralized Anxiety DisorderNCT06701903

Phase 2Q2 2027ITI-1284 10 mgGeneralized Anxiety DisorderNCT06480383

Phase 2Q3 2027ITI-1284Psychosis Associated With Alzheimer's DiseaseNCT06540833

Phase 2Q4 2027ITI-1284Agitation Associated With Alzheimer's DementiaNCT06651567

Phase 3Q4 2027LumateperoneSchizophrenia, Bipolar Disorder, Autism Spectrum DisorderNCT06229210

Intra-Cellular Therapies Inc.

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