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Intra-Cellular Therapies

Intra-Cellular Therapies logo
🇺🇸United States
Ownership
Public
Established
2002-01-01
Employees
610
Market Cap
$7.8B
Website
http://www.intracellulartherapies.com
Introduction

Intra-Cellular Therapies, Inc. operates as a biopharmaceutical company. It focuses on the discovery and clinical development of small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. The firm’s lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. It also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer's disease and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer's disease. The company was founded by Paul Greengard and Sharon Mates in 2002 and is headquartered in New York, NY.

Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
First Posted Date
2021-08-02
Last Posted Date
2025-05-02
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
485
Registration Number
NCT04985942
Locations
🇨🇿

Clinical site, Plzen, Czechia

🇸🇰

Clinical Site, Zlaté Moravce, Slovakia

Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Phase 3
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2021-07-12
Last Posted Date
2024-11-07
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
228
Registration Number
NCT04959032
Locations
🇷🇸

Clinical Site, Novi Kneževac, Serbia

🇷🇸

Clinical site, Belgrade, Serbia

Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Other: Placebo
First Posted Date
2021-06-22
Last Posted Date
2023-03-14
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
48
Registration Number
NCT04934124
Locations
🇺🇸

Clinical Site, Eatontown, New Jersey, United States

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

Phase 1
Completed
Conditions
Schizophrenia
Pediatric
Interventions
First Posted Date
2021-03-03
Last Posted Date
2024-08-12
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
26
Registration Number
NCT04779177
Locations
🇺🇸

Clinical Site, Decatur, Georgia, United States

Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia

Phase 1
Completed
Conditions
Schizophrenia
Interventions
First Posted Date
2021-01-14
Last Posted Date
2022-12-05
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
37
Registration Number
NCT04709224
Locations
🇺🇸

Clinical Site, Marlton, New Jersey, United States

Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Phase 3
Completed
Conditions
Bipolar Depression
Major Depressive Disorder
Interventions
Drug: Placebos
First Posted Date
2020-02-26
Last Posted Date
2025-03-19
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
488
Registration Number
NCT04285515
Locations
🇺🇦

Clinical Site, Vinnytsia, Ukraine

🇺🇦

Clinical site, Odesa, Ukraine

Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Placebo
First Posted Date
2018-04-05
Last Posted Date
2019-11-06
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
26
Registration Number
NCT03489772
Locations
🇺🇸

Laureate Institute for Brain Research, Inc., Tulsa, Oklahoma, United States

Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

Phase 1
Completed
Conditions
Heart Failure, Systolic
Interventions
Other: Placebo
First Posted Date
2018-01-02
Last Posted Date
2020-12-24
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
36
Registration Number
NCT03387215
Locations
🇺🇸

Duke Clinical Research Institute, Durham, North Carolina, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

Phase 1
Completed
Conditions
Parkinson Disease
Interventions
Other: Placebo
First Posted Date
2017-08-22
Last Posted Date
2018-12-20
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
40
Registration Number
NCT03257046
Locations
🇺🇸

Atlanta Center for Medical Research, Atlanta, Georgia, United States

🇺🇸

Duke Early Phase Research Unit, Durham, North Carolina, United States

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

Phase 3
Completed
Conditions
Bipolar Depression
Interventions
Other: Placebo
First Posted Date
2017-08-15
Last Posted Date
2022-06-03
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
381
Registration Number
NCT03249376
Locations
🇺🇦

Clinical Site, Vinnytsia, Ukraine

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