Product Description
Lumateperone is a medication used in the management and treatment of schizophrenia and other neuropsychiatric disorders. It is a second-generation atypical antipsychotic medication that exhibits a novel mechanism of action. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK560844/)
Mechanisms of Action: 5-HT2A Agonist,D2 Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: United States
Approved Indications: Bipolar Disorder | Depressive Disorder | Schizophrenia
Known Adverse Events: Depressive Disorder | Dizziness | Schizophrenia
Company: Intra-Cellular Therapies
Company Location: NEW YORK NY 10016
Company CEO: Sharon Mates
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Bulgaria, Croatia, Czech Republic, Finland, France, Germany, Hungary, India, Lithuania, Poland, Russia, Serbia, Slovakia, Spain, Sweden, Ukraine, United States
Active Clinical Trial Count: 29
Highest Development Phases
Phase 3: Autism Spectrum Disorder|Bipolar Disorder|Depressive Disorder, Major|Schizophrenia
Phase 2: Alzheimer Disease|Borderline Personality Disorder|Conduct Disorder|Generalized anxiety disorder|Psychomotor Agitation|Psychotic Disorders|Vision Disorders|Vision, Low
Phase 1: Affective Disorders, Psychotic|Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ITI-007-321 | P3 |
Recruiting |
Schizophrenia|Bipolar Disorder |
2027-12-01 |
95% |
| ITI-1284-101 | P2 |
Recruiting |
Psychomotor Agitation|Alzheimer Disease |
2027-10-01 |
|
| ITI-1284-201 | P2 |
Recruiting |
Alzheimer Disease|Schizophrenia|Psychotic Disorders |
2027-09-01 |
|
| ITI-1284-301 | P2 |
Recruiting |
Vision Disorders|Vision, Low|Conduct Disorder |
2027-06-01 |