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ITI-1284

Phase 2Small molecule

IIntra-Cellular Therapies, Inc.

ITI-1284 is one of 79 small molecule programs targeting Agitation. It is currently in Phase 2.

5

Indications

5

Total Trials

5

Active Trials

78

Competitors

Pipeline

Status by Indication[3][1]

Indication

PsychosisActive, not recruiting

Generalized Anxiety DisorderActive, not recruiting

Psychosis Associated With Alzheimer's DiseaseRecruiting

Alzheimer's DementiaRecruiting

PsychosisPhase 2

Active, not recruiting

Generalized Anxiety DisorderPhase 2

Active, not recruiting

Psychosis Associated With Alzheimer's DiseasePhase 2

Recruiting

Alzheimer's DementiaPhase 2

Recruiting

Competition

Competitive Landscape

98 competitors in Psychosis

#DrugCompanyPhaseTrials

Epidiolex

Jazz Pharmaceuticals

Cysteine Hydrochloride

Provigil

NNuvo Research GmbH

Prozac

VVitae Pharmaceuticals Inc., an Allergan affiliate

Karxt

Bristol-Myers Squibb

Keppra

Rituxan

Karx-EC

Bristol-Myers Squibb

Niaspan

Bifeprunox

SSolvay Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Study completion

NCT06299410

Q2 2027

Phase 2Recruiting

Generalized Anxiety Disorder

NCT06701903

Phase 2Recruiting

Generalized Anxiety Disorder

NCT06480383

Q4 2027

Phase 2Recruiting

Alzheimer's Dementia

NCT06651567

Q4 2028

Phase 2Recruiting

Psychosis Associated With Alzheimer's Disease

NCT06540833

Clinical

Trials by Indication[1]

Generalized Anxiety Disorder2 trials

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

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 2·NCT06701903·570 enrolled

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

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 2·NCT06480383·705 enrolled

Psychosis Associated With Alzheimer's Disease1 trial

A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Psychosis Associated With Alzheimer's Disease

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 2·NCT06540833·370 enrolled

Alzheimer's Dementia1 trial

A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 2·NCT06651567·320 enrolled

Unspecified1 trial

An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 1·NCT06299410·42 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for ITI-1284. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ITI-1284 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ITI-1284. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Intra-Cellular Therapies, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: IIntra-Cellular Therapies, Inc.

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