Floatz Rating
BB67/100
Confidence
Indicative
Sponsor
Biogen
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.
68High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05655507CT.gov Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD) | — | Completed | — | — | — |
NCT04476030CT.gov A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder | — | Completed | — | — | — |
NCT04442490CT.gov A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD) | — | Completed | — | — | — |
NCT04007367CT.gov A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder | — | Terminated | — | — | — |
NCT03864614CT.gov A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD) | — | Completed | — | — | — |
NCT03771664CT.gov A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia | — | Terminated | — | — | — |
NCT03672175CT.gov A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder | — | Completed | — | — | — |
NCT03692910CT.gov A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode | — | Completed | — | — | — |
NCT03000530CT.gov A Study to Evaluate SAGE-217 in Participants With Moderate to Severe 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 |
|---|---|---|---|
| Zuranolone (this asset) | Biogen | P3 | BB · 67 |
| Risperidone | Johns Hopkins University | P4 | BBB |
| Selegiline | Corium Innovations, Inc. | P4 | BBB |
| Edivoxetine | Eli Lilly and Company | P3 | BBB |
| Vortioxetine | Mayo Clinic | P4 | BBB |
| Brexpiprazole | Nova Scotia Health Authority | P4 | BBB |
| (1S,2R)-MILNACIPRAN | Allergan | P4 | BBB |
| Amitriptyline | e-Therapeutics PLC | P4 | BBB |
| Desvenlafaxine | Pfizer | P4 | BBB |
+42 more in the Major Depressive Disorder cohort
Other indications for Zuranolone
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Postpartum Depression | — | P3 | BB · 68 |
| Insomnia | — | P3 | B · 60 |
| Bipolar I Disorder | — | P2 | B · 57 |
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. Zuranolone in Major Depressive 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/zuranolone-major-depressive-disorder
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