Floatz Rating
B56/100
Confidence
Indicative
Sponsor
Alkermes, 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.
52High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05303064CT.gov Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder | — | Recruiting | — | — | — |
NCT04987229CT.gov Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects | — | Enrolling By Invitation | — | — | — |
NCT02161718CT.gov A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder | — | Completed | — | — | — |
NCT01903837CT.gov A Study of ALKS 3831 in Adults With Schizophrenia | — | 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 |
|---|---|---|---|
| Samidorphan (this asset) | Alkermes, Inc. | P3 | B · 56 |
| 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 Samidorphan
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Bipolar I Disorder | — | P3 | B · 62 |
| Alcohol Abuse | — | P2 | B · 57 |
| Bipolar Disorder | — | N/A | D · 30 |
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. Samidorphan 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/samidorphan-schizophrenia
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