Floatz Rating
B63/100
Confidence
Indicative
Sponsor
Axsome Therapeutics, Inc.
Modality
unclassified
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
61High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06223880CT.gov A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms | — | Recruiting | — | — | — |
NCT04971291CT.gov An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients | — | Unknown | — | — | — |
NCT04634669CT.gov Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) | — | Terminated | — | — | — |
NCT04608396CT.gov Mechanistic Evaluation of Response in TRD (MERIT) | — | Completed | — | — | — |
NCT04019704CT.gov A Trial of AXS-05 in Patients With Major Depressive Disorder | — | Completed | — | — | — |
NCT03595579CT.gov Assessing Symptomatic Clinical Episodes in Depression | — | Completed | — | — | — |
NCT02741791CT.gov A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant 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 |
|---|---|---|---|
| Axs-05 (this asset) | Axsome Therapeutics, Inc. | Approved | B · 63 |
| Risperidone | Johns Hopkins University | P4 | BBB |
| Selegiline | Corium Innovations, Inc. | P4 | BBB |
| Edivoxetine | Eli Lilly and Company | P3 | BBB |
| Brexpiprazole | Nova Scotia Health Authority | P4 | BBB |
| Vortioxetine | Mayo Clinic | P4 | BBB |
| (1S,2R)-MILNACIPRAN | Allergan | P4 | BBB |
| Amitriptyline | e-Therapeutics PLC | P4 | BBB |
| 17.BETA.-(1-KETOETHYL)-.DELTA. SUP(5)-ANDROSTEN-3.BETA.-OL | Massachusetts General Hospital | P4 | BBB |
+42 more in the Major Depressive Disorder cohort
Other indications for Axs-05
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Alzheimer Disease | — | P3 | BB · 70 |
| Depressive Disorder | — | P3 | B · 56 |
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. Axs-05 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/axs-05-major-depressive-disorder
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