lumateperone
lumateperone: sourced relationships with 1 company · 15 clinical trials tracked · 1 FDA decision.
lumateperone evidence translation
What we can confirm
1 FDA record · 15 tracked trials
What it means
What to watch
Prepared research question
How could lumateperone → ITCI affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence7 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (3)
| Company | Dated record stage |
|---|---|
| Intra-Cellular Therapies, Inc. (ITCI) Schizophrenia or Schizoaffective | Phase 3 |
| Intra-Cellular Therapies, Inc. (ITCI) Schizophrenia (adults); Bipolar depression (adults) | Approved |
| Intra-Cellular Therapies, Inc. (ITCI) Schizophrenia; Schizophrenia or Schizoaffective; Bipolar Dis… | Phase 3 |
Clinical Trial Registry Records (15)showing 10 most recent
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone
Primary endpoint: Change from DB Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Week 6
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression
Primary endpoint: MADRS
Lumateperone for Late-Life Depression
Primary endpoint: Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score
A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder
Primary endpoint: Pharmacokinetics: Cmax,oral
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
Primary endpoint: Young Mania Rating Scale (YMRS)
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
Primary endpoint: Young Mania Rating Scale (YMRS)
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
Primary endpoint: Children's Depression Rating Scale-Revised (CDRS-R)
An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder
Primary endpoint: Pharmacokinetics: Cmax
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Primary endpoint: Body Mass Index (BMI)
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder
Primary endpoint: Incidence of Common Adverse Events
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with lumateperone?
lumateperone has dated SEC/FDA relationship records for Intra-Cellular Therapies, Inc..
How many clinical trials involve lumateperone?
BioSniper tracks 15 clinical trials involving lumateperone.
What is lumateperone's latest FDA decision?
The most recent tracked FDA decision for lumateperone is Approval for 1 INDICATIONS AND USAGE CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2) ] . Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ]. CAPLYTA is an atypical antipsychotic , dated December 20, 2019.