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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.

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Phase 3
Recruiting
Conditions
Bipolar Depression
Interventions
Drug: Lumateperone
Drug: Placebo
First Posted Date
2024-04-18
Last Posted Date
2024-07-29
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
384
Registration Number
NCT06372964
Locations
🇺🇸

Clinical Site, Bellevue, Washington, United States

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

Phase 1
Recruiting
Conditions
Healthy Volunteers
Interventions
Drug: ITI-1284 10 mg
Drug: ITI-1284 20 mg
First Posted Date
2024-03-07
Last Posted Date
2024-05-03
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
12
Registration Number
NCT06299410
Locations
🇺🇸

Clinical Site 1, New Haven, Connecticut, United States

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder

Phase 3
Recruiting
Conditions
Schizophrenia
Bipolar Disorder
Interventions
First Posted Date
2024-01-29
Last Posted Date
2024-01-30
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
500
Registration Number
NCT06229210
Locations
🇺🇸

Clinical Site, Oklahoma City, Oklahoma, United States

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

Phase 3
Recruiting
Conditions
Major Depressive Disorder
Interventions
Drug: Lumateperone
Drug: Placebo
First Posted Date
2023-05-09
Last Posted Date
2024-11-01
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
470
Registration Number
NCT05850689
Locations
🇧🇬

Clincal Site, Stara Zagora, Bulgaria

🇪🇸

Clinical Site, Zamora, Spain

Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

Phase 2
Recruiting
Conditions
Parkinson Disease
Interventions
Drug: Lenrispodun
Drug: Placebo
First Posted Date
2023-03-13
Last Posted Date
2024-10-23
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
132
Registration Number
NCT05766813
Locations
🇺🇸

Clinical Site, Milwaukee, Wisconsin, United States

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

Phase 1
Recruiting
Conditions
Healthy Volunteers
Interventions
Drug: ITI-333
Other: Placebo
First Posted Date
2023-02-16
Last Posted Date
2023-03-03
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
32
Registration Number
NCT05732194
Locations
🇺🇸

Clinical Site 1, Miami, Florida, United States

A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

Phase 1
Recruiting
Conditions
Healthy Volunteers
Interventions
Drug: ITI-333
First Posted Date
2022-07-22
Last Posted Date
2023-01-11
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
24
Registration Number
NCT05470101
Locations
🇺🇸

Clinical Site 1, Saint Louis, Missouri, United States

🇺🇸

Clinical Site 2, Creve Coeur, Missouri, United States

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2021-09-29
Last Posted Date
2024-12-19
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
812
Registration Number
NCT05061719
Locations
🇵🇱

Clinical SIte, Toruń, Poland

🇨🇿

Clinical site, Brno, Czechia

🇸🇪

Clinical Site, Stockholm, Sweden

Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Phase 3
Completed
Conditions
Major Depressive Disorder
Interventions
Drug: Placebo
Drug: Lumateperone
First Posted Date
2021-09-29
Last Posted Date
2024-06-27
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
480
Registration Number
NCT05061706
Locations
🇩🇪

Clinical site, Freiburg im Breisgau, Germany

🇸🇪

Clinical Site, Stockholm, Sweden

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: Lumateperone
Drug: Placebo
First Posted Date
2021-08-02
Last Posted Date
2024-04-24
Lead Sponsor
Intra-Cellular Therapies, Inc.
Target Recruit Count
485
Registration Number
NCT04985942
Locations
🇨🇿

Clinical site, Plzen, Czechia

🇸🇰

Clinical Site, Zlaté Moravce, Slovakia

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