Floatz Rating
B60/100
Confidence
Indicative
Sponsor
Intra-Cellular Therapies, Inc.
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
45Indicative
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06462612CT.gov Study of Lumateperone in the Treatment of Patients With Bipolar Mania | — | Recruiting | — | — | — |
NCT06462586CT.gov Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania | — | Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
95High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Manic Bipolar Affective Disorder
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Lumateperone (this asset) | Intra-Cellular Therapies, Inc. | P3 | B · 60 |
| Risperidone | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | P4 | BBB |
| Lithium, Elemental | University of Cincinnati | P4 | BBB |
| Brexpiprazole | Otsuka Pharmaceutical Development & Commercialization, Inc. | P3 | BB |
| Lamotrigine | Medical University of South Carolina | P4 | BB |
| Allopurinol | Sheba Medical Center | P4 | BB |
| Quetiapine | University of Cincinnati | P4 | BB |
| Olanzapine | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | P4 | BB |
| Cariprazine | AbbVie | P3 | BB |
+19 more in the Manic Bipolar Affective Disorder cohort
Other indications for Lumateperone
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Schizophrenia | — | P4 | BBB · 72 |
| Major Depressive Disorder | — | P4 | BB · 68 |
| Bipolar Depression | — | 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.
Related assets
Citation
Floatz Terminal. Lumateperone in Manic Bipolar Affective Disorder. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/lumateperone-manic-bipolar-affective-disorder
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