Floatz Rating
CC42/100
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.
32Moderate confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
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.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Bipolar Disorder
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Sep-380135 (this asset) | Otsuka Pharmaceutical Development & Commercialization, Inc. | P1 | CC · 42 |
| Asenapine | Dr. Stavroula Rakitzi | P4 | BBB |
| Quetiapine | First Affiliated Hospital of Zhejiang University | P4 | BBB |
| Lamotrigine | Johns Hopkins University | P4 | BBB |
| Lithium, Elemental | University of Aarhus | P4 | BBB |
| Citalopram | University of Texas Southwestern Medical Center | P4 | BBB |
| Escitalopram | First Affiliated Hospital of Zhejiang University | P4 | BBB |
| Paroxetine | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | P4 | BBB |
| Valproic Acid | University of New Mexico | P4 | BBB |
+42 more in the Bipolar Disorder cohort
Other indications for Sep-380135
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Schizophrenia | — | P1 | CC · 44 |
| Major Depressive Disorder | — | P1 | CC · 44 |
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 Bipolar 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/sep-380135-bipolar-disorder
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