Lumateperone
Major Depressive Disorder
Floatz Rating
BB68/100
Confidence
Indicative
Sponsor
Eric Lenze
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.
70High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07623135CT.gov Lumateperone for Late-Life Depression | — | Not Yet Recruiting | — | — | — |
NCT07369115CT.gov Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse | — | Not Yet Recruiting | — | — | — |
NCT05850689CT.gov Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | — | Recruiting | — | — | — |
NCT05061719CT.gov An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | — | Completed | — | — | — |
NCT05061706CT.gov Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | — | Completed | — | — | — |
NCT04985942CT.gov Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | — | Completed | — | — | — |
NCT04285515CT.gov Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder | — | 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 · Major Depressive Disorder
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Lumateperone (this asset) | Eric Lenze | Approved | BB · 68 |
| Selegiline | Corium Innovations, Inc. | P4 | BBB |
| Risperidone | Johns Hopkins University | P4 | BBB |
| Edivoxetine | Eli Lilly and Company | P3 | BBB |
| Brexpiprazole | Nova Scotia Health Authority | P4 | BBB |
| Vortioxetine | Mayo Clinic | P4 | BBB |
| (1S,2R)-MILNACIPRAN | Allergan | P4 | BBB |
| Amitriptyline | e-Therapeutics PLC | P4 | BBB |
| Jnj-54135419 | Shanghai Mental Health Center | P4 | BBB |
+42 more in the Major Depressive Disorder cohort
Other indications for Lumateperone
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Schizophrenia | — | P4 | BBB · 72 |
| 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 Major Depressive Disorder. 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-major-depressive-disorder
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