ITI-1284

Phase 3Small molecule

IIntra-Cellular Therapies, Inc.

ITI-1284 is one of 23 small molecule programs targeting Generalized Anxiety Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Generalized Anxiety DisorderRecruiting

Generalized Anxiety DisorderPhase 3

Recruiting

Competition

Competitive Landscape

23 competitors in Generalized Anxiety Disorder

#DrugCompanyPhaseTrials

Lexapro

AbbVie

Approved

9 2

Cymbalta

Jazz Pharmaceuticals

Approved

7 3

Buspar

Bristol-Myers Squibb

Approved

1 4

Geodon

Pfizer

Approved

1 5

Paxil

SSebela Pharmaceuticals Development LLC

Approved

9 6

Ativan

BBausch Health Americas, Inc.

Approved

4 7

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

4 8

Lunesta

Akero Therapeutics

Approved

2 9

Xanax

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 10

Zoloft

VViatris Specialty LLC

Approved

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

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Generalized Anxiety Disorder

NCT06480383

Phase 2Recruiting

Alzheimer's Dementia

NCT06651567

Q3 2028

Phase 2Recruiting

Generalized Anxiety Disorder

NCT06701903

Q4 2028

Phase 2Recruiting

Psychotic Disorders

NCT06540833

Q1 2030

Phase 3Recruiting

Generalized Anxiety Disorder

NCT07807865

Clinical

Trials by Indication[1]

Generalized Anxiety Disorder3 trials

An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment

Recruiting·IIntra-Cellular Therapies, Inc.·Phase 3·NCT07807865·900 enrolled

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder Who Have Had Inadequate Response to Generalized Anxiety Disorder Treatment

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment

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

Psychotic Disorders1 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

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

Completed·IIntra-Cellular Therapies, Inc.·Phase 1·NCT06299410·58 enrolled

Sources

References

[1]
ClinicalTrials.gov — 6 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 3[1]
Company: IIntra-Cellular Therapies, Inc.

ITI-1284

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q3 2028

Q4 2028

Q1 2030

Trials by Indication[1]

Generalized Anxiety Disorder3 trials

Alzheimer's Dementia1 trial

Psychotic Disorders1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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