Key Highlights

Risk & Performance

Pipeline Risk Assessment

Pipeline Risk Assessment

Based on historical performance

Low Risk

Score: 15/100

Failure Rate

6.5%

3 terminated/withdrawn out of 46 trials

Success Rate

90.6%

+4.0% vs industry average

Late-Stage Pipeline

50%

23 trials in Phase 3/4

Results Transparency

52%

15 of 29 completed trials have results

Key Signals

12 recruiting15 with results

Enrollment Performance

Analytics

Phase 3
22(47.8%)
Phase 1
14(30.4%)
Phase 2
9(19.6%)
Phase 4
1(2.2%)
46Total
Phase 3(22)
Phase 1(14)
Phase 2(9)
Phase 4(1)

Activity Timeline

Global Presence

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Clinical Trials (46)

Showing 20 of 46 trials
NCT07856420Phase 3Not Yet Recruiting

A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment

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

NCT07807865Phase 3Recruiting

A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)

Role: lead

NCT06299410Phase 1Completed

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 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

NCT06701903Phase 2Recruiting

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

Role: lead

NCT06480383Phase 2Recruiting

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

Role: lead

NCT06690398Phase 3Recruiting

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

Role: lead

NCT05850689Phase 3Recruiting

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

Role: lead

NCT06706674Phase 3Recruiting

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

Role: lead

NCT07623135Phase 3Recruiting

Lumateperone for Late-Life Depression

Role: collaborator

NCT07747389Phase 3Not Yet Recruiting

A Study of Lumateperone Versus Placebo in Participants With Major Depressive Disorder

Role: lead

NCT06627413Phase 1Completed

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

Role: lead

NCT05356013Phase 2Completed

Caplyta in Borderline Personality Disorder

Role: collaborator

NCT06557902Phase 1Completed

Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Role: lead

NCT06462586Phase 3Completed

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

Role: lead

NCT05766813Phase 2Completed

Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

Role: lead

NCT06462612Phase 3Completed

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

Role: lead