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Intra-Cellular Therapies clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — current trials in our USA and India registers with Intra-Cellular Therapies as lead sponsor. Synced 26 Sep 2026
10Current trials
10Recruiting now
2Drugs in these trials
2Trial registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

Intra-Cellular Therapies is the lead sponsor of 10 current clinical trials in our USA and India registers. 10 are recruiting patients now. The most common phase is Phase 3. The drugs named most often in its trials are Lumateperone and ITI-1284. The most-studied condition is Generalized Anxiety Disorder.

ClinicalTrials.gov trials by status

  • Recruiting10100%

Trials by phase

  • Phase 3660%
  • Phase 2440%
01

Clinical trials sponsored by Intra-Cellular Therapies

10 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
NCT06372964 · Bipolar Depression
Phase 3 Recruiting 2024-05 USA, India
Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
NCT05850689 · ClinicalTrials.gov ↗ · Major Depressive Disorder
Phase 3 Recruiting 2023-05 USA, India
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
NCT06701903 · Generalized Anxiety Disorder
Drug: ITI-1284
Phase 2 Recruiting 2024-11 USA
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
NCT06480383 · ClinicalTrials.gov ↗ · Generalized Anxiety Disorder
Drug: ITI-1284
Phase 2 Recruiting 2024-08 USA
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
NCT06540833 · ClinicalTrials.gov ↗ · Psychotic Disorders, Alzheimer Disease
Drug: ITI-1284
Phase 2 Recruiting 2024-08 USA
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
NCT06706674 · ClinicalTrials.gov ↗ · Irritability Associated With Autism Spectrum Disorder
Phase 3 Recruiting 2024-12 USA
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
NCT06690398 · ClinicalTrials.gov ↗ · Irritability Associated With Autism Spectrum Disorder
Phase 3 Recruiting 2024-11 USA
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
NCT07807865 · ClinicalTrials.gov ↗ · Generalized Anxiety Disorder
Drug: ITI-1284
Phase 3 Recruiting 2026-09 USA
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
NCT06229210 · ClinicalTrials.gov ↗ · Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
Phase 3 Recruiting 2024-01 USA
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
NCT06651567 · ClinicalTrials.gov ↗ · Agitation Associated With Alzheimer's Dementia
Phase 2 Recruiting 2024-10 USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

02

Drugs in Intra-Cellular Therapies trials

2 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

03

Conditions in Intra-Cellular Therapies trials

10 conditions
Generalized Anxiety Disorder3Irritability Associated With Autism Spectrum Disorder2Bipolar Depression1Major Depressive Disorder1Psychotic Disorders1Alzheimer Disease1Schizophrenia1Bipolar Disorder1Autism Spectrum Disorder1Agitation Associated With Alzheimer's Dementia1
04

By trial register

RegisterTrialsRecruiting
Clinical trials in USA1010
Clinical trials in India22

A trial with sites in more than one country appears in each of those registers.

05

Other sponsors in Generalized Anxiety Disorder

SponsorTrials
Beijing Union Pharmaceutical Factory3
Otsuka Pharmaceutical Development & Commercialization2
Definium Therapeutics US2
Yi Yang1

Sponsors with the most current trials registered for this condition.

06

Questions about Intra-Cellular Therapies trials

How many clinical trials does Intra-Cellular Therapies sponsor?

Intra-Cellular Therapies is the lead sponsor of 10 current trials on ClinicalTrials.gov in our USA and India registers, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Intra-Cellular Therapies trials recruiting?

Yes. 10 of its 10 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is Intra-Cellular Therapies testing?

Its current trials name 2 drugs and biologicals as interventions. The most frequent are Lumateperone (5) and ITI-1284 (4). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.