Lumateperone
Bipolar Depression
Floatz Rating
BB66/100
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.
59High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06372964CT.gov Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients | — | Recruiting | — | — | — |
NCT04285515CT.gov Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder | — | Completed | — | — | — |
NCT03249376CT.gov Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally | — | Completed | — | — | — |
NCT02600507CT.gov Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression | — | Completed | — | — | — |
NCT02600494CT.gov Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Bipolar Depression
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Lumateperone (this asset) | Intra-Cellular Therapies, Inc. | P3 | BB · 66 |
| Lurasidone | NeuroRx, Inc. | P4 | A |
| Lithium, Elemental | Dr. Inge Winter | P4 | BBB |
| Quetiapine | Dr. Inge Winter | P4 | BBB |
| Lamotrigine | Stony Brook University | P4 | BBB |
| (±)-2-(O-Chlorophenyl)-2-(Methylamino)Cyclohexanone | Joshua Rosenblat | P4 | BBB |
| Nrx-101 | NeuroRx, Inc. | P3 | BBB |
| Escitalopram | Dr. Inge Winter | P4 | BBB |
| Valproic Acid | Ewha Womans University | P4 | BB |
+42 more in the Bipolar Depression cohort
Other indications for Lumateperone
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Schizophrenia | — | P4 | BBB · 72 |
| Major Depressive Disorder | — | P4 | BB · 68 |
| 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 Bipolar Depression. 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-bipolar-depression
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