Floatz Rating
BB70/100
Confidence
Indicative
Sponsor
University of Oxford
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.
74High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06384209CT.gov The Friendship Bench Plus Trial | — | Recruiting | — | — | — |
NCT07478796CT.gov TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children | — | Recruiting | — | — | — |
NCT06860958CT.gov Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients | — | Recruiting | — | — | — |
NCT04446039CT.gov Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea | — | Completed | — | — | — |
NCT03779789CT.gov Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment | — | Completed | — | — | — |
NCT03569475CT.gov Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder | — | Completed | — | — | — |
NCT02709655CT.gov Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD) | — | Completed | — | — | — |
NCT02709746CT.gov Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD) | — | Completed | — | — | — |
NCT02431806CT.gov Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder | — | Completed | — | — | — |
NCT02372799CT.gov Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22) | — | Completed | — | — | — |
Show 16 more trialsShow fewer
NCT01896349CT.gov Interpersonal Psychotherapy for Treatment Resistant Depression | — | Unknown | — | — | — |
NCT01687478CT.gov A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression | — | Terminated | — | — | — |
NCT01699490CT.gov Role of Inflammation Factors and Insulin Resistance in Major Depressive Disorder | — | Unknown | — | — | — |
NCT01764867CT.gov Algorithm Guided Treatment Strategies for Major Depressive Disorder | — | Unknown | — | — | — |
NCT01635218CT.gov Homeopathic Treatment for Depression in Peri- and Postmenopausal Women | — | Completed | — | — | — |
NCT01372150CT.gov A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD | — | Completed | — | — | — |
NCT01360866CT.gov Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) | — | Completed | — | — | — |
NCT01254305CT.gov Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder | — | Completed | — | — | — |
NCT01243957CT.gov A Study to Measure if There is Any Difference in How the Body Breaks Down or Inactivates Either Fluoxetine or LY2216684 When Both of These Medicines Are Given Together. | — | Completed | — | — | — |
NCT00958568CT.gov A Study in Relapse Prevention of Treatment-Resistant Depression | — | Completed | — | — | — |
NCT00351910CT.gov Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder | — | Completed | — | — | — |
NCT00188942CT.gov A Neuroimaging Investigation of Brain Activity in Major Depressive Disorder and Bipolar Disorder | — | Completed | — | — | — |
NCT00909155CT.gov Brain Imaging Techniques That Predict Antidepressant Responsiveness | — | Completed | — | — | — |
NCT00035321CT.gov The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression | — | Completed | — | — | — |
NCT00265291CT.gov Antidepressant Treatment of Mexican-Americans: UCLA Pharmacogenetics and Pharmacogenomics Research Group | — | Completed | — | — | — |
NCT00296725CT.gov Dichotic Listening as a Predictor of Medication Response in Depression | — | 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 |
|---|---|---|---|
| Fluoxetine (this asset) | University of Oxford | Approved | BB · 70 |
| Selegiline | Corium Innovations, Inc. | P4 | BBB |
| Risperidone | Johns Hopkins University | 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 Fluoxetine
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Depressive Disorder | — | P4 | BBB · 74 |
| Anxiety Disorder | — | P4 | BBB · 74 |
| Mood Disorder | — | P4 | BBB · 73 |
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. Fluoxetine 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/fluoxetine-major-depressive-disorder-15634
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