Intra-Cellular Therapies
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
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
NCT06706674
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
NCT06690398
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
NCT06701903
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
NCT06651567
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
NCT06540833
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
NCT06480383
Study of Lumateperone in the Treatment of Patients With Bipolar Mania
NCT06462612
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
NCT06462586
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
NCT06372964
Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder
NCT06557902
PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
NCT06299410
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
NCT06229210
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT05850689
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
NCT05766813
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
NCT06627413
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
NCT05732194
A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
NCT05470101
An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT05061719
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT05061706
Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT04985942
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
NCT04959032
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
NCT04779177
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
NCT04709224
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers
NCT04934124
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
NCT04285515
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
NCT03489772
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
NCT03387215
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
NCT03249376
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
NCT03257046
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
NCT02817906
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
NCT02600507
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
NCT02600494
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
NCT02469155
A Trial to Assess the Antipsychotic Efficacy of ITI-007
NCT02282761
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia
NCT02288845
Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
NCT02078310
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
NCT01499563
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 12 |
| Phase 2 | 7 |
| Phase 3 | 18 |
Therapeutic Areas
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.
Read our methodology - how this data is sourced, computed, and verified.
Related
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.