Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Low Risk

Score: 15/100

Failure Rate

7.1%

3 terminated/withdrawn out of 42 trials

Success Rate

88.9%

+2.4% vs industry average

Late-Stage Pipeline

45%

19 trials in Phase 3/4

Results Transparency

63%

15 of 24 completed trials have results

Key Signals

15 recruiting15 with results

Enrollment Performance

Analytics

Phase 3
18(42.9%)
Phase 1
14(33.3%)
Phase 2
9(21.4%)
Phase 4
1(2.4%)
42Total
Phase 3(18)
Phase 1(14)
Phase 2(9)
Phase 4(1)

Activity Timeline

Global Presence

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Clinical Trials (42)

Showing 20 of 42 trials
NCT05356013Phase 2Completed

Caplyta in Borderline Personality Disorder

Role: collaborator

NCT05732194Phase 1Completed

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

Role: lead

NCT06627413Phase 1Completed

Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Role: lead

NCT06540833Phase 2Recruiting

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease

Role: lead

NCT06651567Phase 2Recruiting

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

Role: lead

NCT06480383Phase 2Recruiting

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

Role: lead

NCT06701903Phase 2Recruiting

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

Role: lead

NCT04779177Phase 1Completed

Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder

Role: lead

NCT02600494Phase 3Completed

Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

Role: lead

NCT05061719Phase 3Completed

An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Role: lead

NCT01499563Phase 2Completed

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Role: lead

NCT02469155Phase 3Completed

A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

Role: lead

NCT02282761Phase 3Completed

A Trial to Assess the Antipsychotic Efficacy of ITI-007

Role: lead

NCT05470101Phase 1Completed

A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

Role: lead

NCT06229210Phase 3Recruiting

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Role: lead

NCT06372964Phase 3Recruiting

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Role: lead

NCT06706674Phase 3Recruiting

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

Role: lead

NCT06690398Phase 3Recruiting

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

Role: lead

NCT06462586Phase 3Recruiting

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

Role: lead

NCT05850689Phase 3Recruiting

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

Role: lead