Data updated: Jun 28, 2026
LUMATEPERONE
Trial Activity: Expansion 6 active trials
CNS
Development Insights
Intra-Cellular Therapies, Inc. conducting 10 trials (83%)
8 indications explored (Moderate)
→ major depressive disorder (5 trials)
→ bipolar depression (3 trials)
→ schizophrenia (2 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- N/A
- Dosage Forms
- CAPSULE
LUMATEPERONE Approval History
No approval records found
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Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05061719 results posted | ITI-007-503 | Ph 3 | completed | An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder |
| NCT06372964 | ITI-007-421 | Ph 3 | recruiting | Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients |
| NCT06229210 | ITI-007-321 | Ph 3 | recruiting | Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder |
| NCT06462612 | ITI-007-452 | Ph 3 | recruiting | Study of Lumateperone in the Treatment of Patients With Bipolar Mania |
| NCT06462586 | ITI-007-451 | Ph 3 | recruiting | Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania |
| NCT05850689 | ITI-007-505 | Ph 3 | recruiting | Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder |
| NCT06174116 | STUDY00001339 | Ph 4 | recruiting | Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia |
| NCT05061706 results posted | ITI-007-502 | Ph 3 | completed | Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder |
| NCT04985942 results posted | ITI-007-501 | Ph 3 | completed | Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder |
| NCT04285515 results posted | ITI-007-403 | Ph 3 | completed | Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder |
| NCT05890768 Lumafep | 22-396 | Ph 4 | withdrawn | Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine |
| NCT03249376 results posted | ITI-007-404 | Ph 3 | completed | Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally |
| NCT07623135 IRL Grey-C | 202604086 | Ph 3 | not yet recruiting | Lumateperone for Late-Life Depression |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUMATEPERONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment