Floatz Rating
B62/100
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.
52Moderate 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 | — | — | — |
NCT04987658CT.gov Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder | — | 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 I Disorder
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Samidorphan (this asset) | Alkermes, Inc. | P3 | B · 62 |
| Lurasidone | Massachusetts General Hospital | P4 | BBB |
| Lithium, Elemental | Alzamend Neuro, Inc. | P4 | BBB |
| Escitalopram | Massachusetts General Hospital | P4 | BBB |
| Olanzapine | Alkermes, Inc. | P4 | BBB |
| Asenapine | Organon and Co | P3 | BBB |
| Iloperidone | Vanda Pharmaceuticals | P4 | BBB |
| Lamotrigine | Bristol-Myers Squibb | P4 | BBB |
| Cariprazine | Pakistan Institute of Medical Sciences | P4 | BBB |
+42 more in the Bipolar I Disorder cohort
Other indications for Samidorphan
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Alcohol Abuse | — | P2 | B · 57 |
| Schizophrenia | — | P3 | B · 56 |
| 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 Bipolar I 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/samidorphan-bipolar-i-disorder
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