Intra-Cellular Therapies

37 total trials 14 currently recruiting 22 completed

Intra-Cellular Therapies sponsors 37 registered US clinical trials on ClinicalTrials.gov, 14 of them currently recruiting, and 22 completed. 18 of these trials are in Phase 3-4 (later-stage) and 19 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Healthy Volunteers, with 4 trials.

Trial Pipeline

37 total, page 1 of 1

RECRUITING Phase 3

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

NCT06706674

RECRUITING Phase 3

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

NCT06690398

RECRUITING Phase 2

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder

NCT06701903

RECRUITING Phase 2

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

NCT06651567

RECRUITING Phase 2

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

NCT06540833

RECRUITING Phase 2

Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder

NCT06480383

RECRUITING Phase 3

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

NCT06462612

RECRUITING Phase 3

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

NCT06462586

RECRUITING Phase 3

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

NCT06372964

RECRUITING Phase 1

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

NCT06557902

RECRUITING Phase 1

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

NCT06299410

RECRUITING Phase 3

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

NCT06229210

RECRUITING Phase 3

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

NCT05850689

RECRUITING Phase 2

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

NCT05766813

COMPLETED Phase 1

Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

NCT06627413

COMPLETED Phase 1

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

NCT05732194

COMPLETED Phase 1

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

NCT05470101

COMPLETED Phase 3

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

NCT05061719

COMPLETED Phase 3

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

NCT05061706

COMPLETED Phase 3

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

NCT04985942

COMPLETED Phase 3

Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

NCT04959032

COMPLETED Phase 1

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

NCT04779177

COMPLETED Phase 1

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

NCT04709224

COMPLETED Phase 1

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

NCT04934124

COMPLETED Phase 3

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

NCT04285515

COMPLETED Phase 1

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

NCT03489772

COMPLETED Phase 1

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

NCT03387215

COMPLETED Phase 3

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

NCT03249376

COMPLETED Phase 1

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

NCT03257046

TERMINATED Phase 3

ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

NCT02817906

COMPLETED Phase 3

Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

NCT02600507

COMPLETED Phase 3

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

NCT02600494

COMPLETED Phase 3

A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

NCT02469155

COMPLETED Phase 3

A Trial to Assess the Antipsychotic Efficacy of ITI-007

NCT02282761

COMPLETED Phase 2

Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia

NCT02288845

COMPLETED Phase 1

Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

NCT02078310

COMPLETED Phase 2

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

NCT01499563

What the Pipeline for Intra-Cellular Therapies Shows

According to the ClinicalTrials.gov registry, Intra-Cellular Therapies is linked to 37 US clinical trials across every stage of research activity. Of those, 14 studies are currently recruiting, about 38% of the sponsor's indexed portfolio, and 22 are already marked complete, representing roughly 59% of the total.

The phase mix for Intra-Cellular Therapies reports 18 late-stage studies (Phase 3 and Phase 4 combined) and 19 earlier-phase studies (Phase 1 and Phase 2).

The top therapeutic focus area indexed for Intra-Cellular Therapies is Healthy Volunteers with 4 linked trials, and 9 other condition areas appear in the top list above.

How to read these pipeline numbers

Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.

A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.

That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.