Intra-Cellular Therapies

54 total trials 45 currently recruiting 9 completed

Trial Pipeline

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

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

NCT05732194

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

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

NCT04985942

COMPLETED Phase 1

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

NCT04934124

COMPLETED Phase 1

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

NCT03489772

COMPLETED Phase 3

Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

NCT03249376

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 1

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

NCT02078310

What the Pipeline for Intra-Cellular Therapies Shows

According to the ClinicalTrials.gov registry, Intra-Cellular Therapies is linked to 54 US clinical trials across every stage of research activity. Of those, 45 studies are currently recruiting — about 83% of the sponsor's indexed portfolio — and 9 are already marked complete, representing roughly 17% of the total. 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.

The phase mix for Intra-Cellular Therapies reports 43 late-stage studies (Phase 3 and Phase 4 combined) and 11 earlier-phase studies (Phase 1 and Phase 2). 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.

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. 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.

Related

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