Lumateperone
Schizophrenia
Floatz Rating
BBB72/100
Confidence
Indicative
Sponsor
Louisiana State University Health Sciences Center Shreveport
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
77High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06482554CT.gov Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms. | — | Recruiting | — | — | — |
NCT06174116CT.gov Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia | — | Recruiting | — | — | — |
NCT06229210CT.gov Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder | — | Recruiting | — | — | — |
NCT04959032CT.gov Lumateperone for the Prevention of Relapse in Patients With Schizophrenia | — | Completed | — | — | — |
NCT04779177CT.gov Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder | — | Completed | — | — | — |
NCT04709224CT.gov Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia | — | Completed | — | — | — |
NCT03817528CT.gov ITI-007 (Lumateperone Tosylate) for Schizophrenia | — | Terminated | — | — | — |
NCT02469155CT.gov A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment | — | Completed | — | — | — |
NCT02282761CT.gov A Trial to Assess the Antipsychotic Efficacy of ITI-007 | — | Completed | — | — | — |
NCT02288845CT.gov Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia | — | Completed | — | — | — |
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NCT01499563CT.gov Study of a Novel Antipsychotic ITI-007 in Schizophrenia | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Schizophrenia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Lumateperone (this asset) | Louisiana State University Health Sciences Center Shreveport | Approved | BBB · 72 |
| Xanomeline | European Group for Research In Schizophrenia | P4 | BBB |
| Trospium | European Group for Research In Schizophrenia | P4 | BBB |
| Asenapine | Noven Pharmaceuticals, Inc. | P4 | BBB |
| Lurasidone | Aziende Chimiche Riunite Angelini Francesco S.p.A | P4 | BBB |
| Brexpiprazole | Humanis Saglık Anonim Sirketi | P4 | BBB |
| Bitopertin | Hoffmann-La Roche | P3 | BBB |
| Pyridoxol | Nucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara | P4 | BBB |
| Ulotaront | Otsuka Pharmaceutical Co., Ltd. | P3 | BBB |
+42 more in the Schizophrenia cohort
Other indications for Lumateperone
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Major Depressive Disorder | — | P4 | BB · 68 |
| Bipolar Depression | — | P3 | BB · 66 |
| Alzheimer Disease | — | P3 | BB · 66 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Citation
Floatz Terminal. Lumateperone in Schizophrenia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 13, 2026. https://terminal.floatz.ai/assets/lumateperone-schizophrenia
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