Product Description
Fluoxetine is used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder. It is also used together with olanzapine to treat depression that is part of bipolar disorder and treatment resistant depression in patients who have received at least 2 previous treatments but did not work well. (Sourced from: https://www.mayoclinic.org/drugs-supplements/fluoxetine-oral-route/description/drg-20063952)
Mechanisms of Action: SSR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Obsessive-Compulsive Disorder | Panic Disorder | Bulimia Nervosa | Bipolar Disorder | Depressive Disorder | Depressive Disorder, Major | Depressive Disorder, Treatment-Resistant | Bulimia
Known Adverse Events: Panic Disorder | Bulimia Nervosa | Depressive Disorder | Depressive Disorder, Major | Tremor | Insomnia | Pharyngitis | Sinusitis | Anorexia | Asthenia | Bulimia | Diarrhea | Dyspepsia
Company: Eli Lilly
Company Location: INDIANAPOLIS IN 46285
Company CEO: David A. Ricks
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, Bulgaria, Canada, China, Colombia, Estonia, France, Germany, Hungary, Israel, Italy, Korea, Latvia, Mexico, Poland, Russia, Serbia, South Africa, Spain, Ukraine, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: COVID-19|Depressive Disorder, Major|Depressive Disorder, Treatment-Resistant|Severe Acute Respiratory Syndrome
Phase 2: Brain Infarction|Cerebrovascular Disorders|Ischemic Stroke|Stress Disorders, Post-Traumatic
Phase 1: Cholangitis, Sclerosing|Inflammatory Bowel Diseases
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| S-21-02 (Fluoxetine) | P2 |
Recruiting |
Stress Disorders, Post-Traumatic |
2026-03-01 |
|
| FMT-PSC | P1 |
Not yet recruiting |
Inflammatory Bowel Diseases|Cholangitis, Sclerosing |
2025-03-31 |
|
| TOGETHER_2 | P3 |
Recruiting |
Severe Acute Respiratory Syndrome|COVID-19 |
2024-06-01 |
|
| FLOW | P2 |
Completed |
Brain Infarction|Ischemic Stroke|Cerebrovascular Disorders |
2022-09-30 |