Intra-Cellular Therapies

Open enrollment across a mixed-phase pipeline

According to ClinicalTrials.gov-derived indexes, Intra-Cellular Therapies sits in the top decile of US sponsors by registered trial count (#456 of 15,742 sponsors by registered trial count).

37 total trials 14 currently recruiting 22 completed top decile by trial count

Intra-Cellular Therapies: 37 sponsored US clinical trials, 14 recruiting.

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.

Top-decile sponsor footprint

Intra-Cellular Therapies ranks in the top decile of sponsors by registered trial count (#456 of 15,742 sponsors by registered trial count). Volume at this scale usually reflects a long institutional pipeline, read phase tilt and therapeutic areas below before treating it as current-year activity.

Trial completion reliability score

C 79/100

22 of 23 decided trials (Completed vs. Terminated on ClinicalTrials.gov) reached their planned completion (95.7%), vs. national p10 68.4% / p90 100% among 1,234 sponsors with at least 10 decided trials. Still-open trials (Recruiting, Active-not-recruiting, Not-yet-recruiting) are excluded since they have not reached an outcome yet.

Open and recent trials

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 is open in the Intra-Cellular Therapies pipeline

14 recruiting of 37 indexed (38% open); 22 completed (59%).

Phase mix: 18 late (III/IV) vs 19 early (I/II) (balanced across stages).

Top condition: Healthy Volunteers (4 trials), 9 others listed.

How open-pipeline share is computed

Recruiting share is recruiting_count divided by trial_count for this sponsor in the public registry export. Status can change between pulls; treat the figure as a research-attention snapshot, not product availability.

Intra-Cellular Therapies: open-pipeline peers nationwide

Peers matched on 37 registered trials and 38% open enrollment, not the therapeutic-area sidebar.

Intra-Cellular Therapies sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot). 2×2 strategic matrix plotting 9 entities by Total trials (X) and Recruiting share (Y), with a crosshair dividing the plot into four quadrants. Higher volume & more openFocused & more openHigher volume, mostly closedSmaller & mostly closed 020406080100 0%10%20%30%40% Total trials Recruiting share Intra-Cellular TherapiesAppalachian State UniversityBracco DiagnosticsCarnegie Mellon UniversityCuteraChildren's National Research InstituteAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)American Thrombosis and Hemostasis NetworkAskBio
Intra-Cellular Therapies sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together. Source: ClinicalTrials.gov (2026-08-08 snapshot).

Intra-Cellular Therapies sits at or above the median trial volume and at or above the median recruiting share among these 9 nationwide peers -- the two do not always move together.

Sponsors near 37 trials (± recruiting share)

Sponsors near 38% open enrollment (± trial volume)

What to do with this Intra-Cellular Therapies page

37 registered trials is a research-attention snapshot, not an endorsement of Intra-Cellular Therapies or any single study.

  • 14 of Intra-Cellular Therapies's trials are currently recruiting, check each one's own eligibility criteria before contacting a site. Browse recruiting trials
  • Healthy Volunteers is the condition Intra-Cellular Therapies studies most, compare against other sponsors active in the same condition before evaluating a specific study. See Healthy Volunteers trials
  • Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide

Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.

Intra-Cellular Therapies pipeline card: 37 registered trials from official public datasets.Report a data error.