Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
Xinyu Zhou
Modality
Small molecule
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.
66High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07011693CT.gov Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I) | — | Not Yet Recruiting | — | — | — |
NCT04589143CT.gov A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine | — | Completed | — | — | — |
NCT04181567CT.gov Comparison of the Efficacy, Safety, and Relapse of ECT to ECT Plus Agomelatine for Depressed Patients | — | Completed | — | — | — |
NCT01483053CT.gov Cardiovascular Effects of Agomelatine and Escitalopram in Patients With Major Depressive Disorder (MDD) | — | Unknown | — | — | — |
NCT01488071CT.gov A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication | — | Completed | — | — | — |
NCT01731899CT.gov Agomelatine in Depressed Patients With Fibromyalgia | — | Completed | — | — | — |
NCT01110902CT.gov Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD) | — | Completed | — | — | — |
NCT01110889CT.gov Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder | — | Completed | — | — | — |
NCT00467402CT.gov Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder | — | Completed | — | — | — |
NCT00463242CT.gov A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD) | — | Completed | — | — | — |
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NCT00411099CT.gov Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder | — | Completed | — | — | — |
NCT00411242CT.gov Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder | — | Completed | — | — | — |
NCT00451490CT.gov The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder | — | Withdrawn | — | — | — |
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 |
|---|---|---|---|
| Agomelatine (this asset) | Xinyu Zhou | Approved | BB · 66 |
| Selegiline | Corium Innovations, Inc. | P4 | BBB |
| Risperidone | Johns Hopkins University | P4 | BBB |
| Edivoxetine | Eli Lilly and Company | P3 | BBB |
| (1S,2R)-MILNACIPRAN | Allergan | P4 | BBB |
| Vortioxetine | Mayo Clinic | P4 | BBB |
| Brexpiprazole | Nova Scotia Health Authority | P4 | BBB |
| Amitriptyline | e-Therapeutics PLC | P4 | BBB |
| Desvenlafaxine | Pfizer | P4 | BBB |
+42 more in the Major Depressive Disorder cohort
Other indications for Agomelatine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Delusional Disorder | — | P4 | BB · 67 |
| Sleep Disorder | — | P4 | BB · 65 |
| Schizoaffective Disorder | — | P4 | BB · 64 |
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. Agomelatine 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/agomelatine-major-depressive-disorder
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