Floatz Rating
CC44/100
Confidence
Indicative
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Modality
UNKNOWN
Development Phase
Phase 1
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
37Moderate confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07455084CT.gov A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults | — | Not Yet Recruiting | — | — | — |
NCT07305779CT.gov A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women | — | Completed | — | — | — |
NCT07549581CT.gov A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode | — | 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 |
|---|---|---|---|
| Sep-380135 (this asset) | Otsuka Pharmaceutical Development & Commercialization, Inc. | P1 | CC · 44 |
| Trospium | European Group for Research In Schizophrenia | P4 | BBB |
| Xanomeline | 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 |
| Iloperidone | Vanda Pharmaceuticals | P4 | BBB |
| Raloxifene | Shanghai Mental Health Center | P4 | BBB |
+42 more in the Schizophrenia cohort
Other indications for Sep-380135
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Major Depressive Disorder | — | P1 | CC · 44 |
| Bipolar Disorder | — | P1 | CC · 42 |
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. Sep-380135 in Schizophrenia. 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/sep-380135-schizophrenia
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