Data updated: Nov 8, 2026
FLUOXETINE (fluoxetine hydrochloride) · Sun Pharma
CNS
Approved 2002-01-29
FLUOXETINE is FDA-approved to treat 6 conditions (same as PROZAC).
Source: FDA Label
Development Insights
Eli Lilly and Company conducting 8 trials (11%)
64 indications explored (Broad Platform)
→ depression (14 trials)
→ major depressive disorder (12 trials)
→ anxiety disorders (3 trials)
1
Indication
--
Phase 3 Trials
24
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-01-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FLUOXETINE Approval History
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2002 to 2021
Oct 2021 SUPPL
Label · Labeling
Aug 2021 SUPPL
Label · Labeling
Jun 2007 SUPPL
Label · Labeling
Jun 2005 SUPPL
Label
Jan 2002 ORIGINAL
Update
What FLUOXETINE Treats
6 indicationsFLUOXETINE is approved for 6 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Obsessive Compulsive Disorder
- Bulimia Nervosa
- Panic Disorder
- Bipolar I Disorder
- Treatment Resistant Depression
Same approved indications as PROZAC (same active ingredient).
Source: FDA Label
Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
70 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06225011 | 23-001744 NCI-2023-09939 | Ph 1 | recruiting | Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer |
| NCT06860958 | 98421 | Ph 3 | recruiting | Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients |
| NCT04850222 results posted | IRB202100808 OCR40926 | Ph 2 | completed | Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma |
| NCT06046859 | IRB202301506 | Ph 4 | recruiting | Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma? |
| NCT06898606 COGUNILA | COGUNILA CAAE: 77979424.0.0000.0107 | Ph 1, Ph 2 | recruiting | Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression |
| NCT07478796 | 213/25 | Ph 4 | recruiting | TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children |
| NCT05041907 PLATCOV | VIR21001 | Ph 2 | recruiting | Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) |
| NCT05814640 STAR-AD | 1stChongqingMU--ZXY | Ph 1, Ph 2 | recruiting | Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) |
| NCT07007221 | IDIM-2024-31723 | Ph 2 | withdrawn | Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV |
| NCT07239011 | 8759 | Ph 1, Ph 2 | recruiting | Dapagliflozin in Depression |
| NCT02751632 STEP | 2015.173 1U01MH105258-01 | Ph 3 | completed | The Staged Treatment in Early Psychosis Study |
| NCT04899687 | 60569 | Ph 2 | recruiting | Study of Dextromethorphan in OCD and Related Disorders |
| NCT07110831 FLUDOPRESS | UI/EC/22/0242 K43TW011995 | Ph 4 | not yet recruiting | Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria |
| NCT03826875 results posted | STUDY00002718 | Ph 2 | completed | Poststroke Depression in Hemorrhagic Stroke |
| NCT06506136 REFLECT | KY20242190 | Ph 2 | not yet recruiting | Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features |
| NCT04760275 SMART | CHLA-19-00478 16008 | Ph 3 | active not recruiting | Fluoxetine vs CBT in Childhood Anxiety Disorders |
| NCT05458479 results posted | 2022P000858 | Ph 4 | completed | Fluoxetine Treatment of Depression in Down Syndrome |
| NCT02473250 results posted | #7056 | Ph 4 | completed | Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging |
| NCT03390933 results posted | IRB17-00768 | Ph 4 | completed | Identifying and Treating Depression in Hemodialysis Patients |
| NCT04377308 results posted | FRIDA COVID19 | Ph 4 | completed | Fluoxetine to Reduce Intubation and Death After COVID19 Infection |
| NCT02357849 FACT results posted | 11-199 | Ph 4 | terminated | Fluoxetine vs Aripiprazole Comparative Trial (FACT) |
| NCT02767999 RECONISE | RC31/14/7388 | Ph 4 | completed | Serotonin Selective Reuptake Inhibitor (SSRI) Effects on Cerebral Connectivity in Acute Ischemic Stroke |
| NCT03779789 VESPA | 2016-0234923 2018-001444-66 | Ph 4 | completed | Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment |
| NCT01545843 results posted | R01MH077690 | Ph 2 | completed | Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression |
| NCT03448159 FLOW | 18-6002 CTO #1465 | Ph 2 | completed | Fluoxetine Opens Window to Improve Motor Recovery After Stroke |
| NCT02022709 | 124119a8601 YG2013MS65 | Ph 4 | completed | Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients |
| NCT05378711 | 13-718F | Ph 2 | completed | Evaluating the Results of Physician and Parent Decisions to Treat Selective Mutism With Fluoxetine |
| NCT03569475 results posted | LVM-MD-14 | Ph 3 | completed | Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder |
| NCT02737930 FLUORESCE results posted | RSRB00058133 | Ph 2 | terminated | Fluoxetine for Visual Recovery After Ischemic Stroke |
| NCT02208466 results posted | 2014P001046 | Ph 2 | completed | Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients |
| NCT02431806 results posted | LVM-MD-11 | Ph 3 | completed | Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder |
| NCT02683213 EFFECTS | EFFECTS2012 2011-006130-16 | Ph 3 | completed | Efficacy of Fluoxetine - a Trial in Stroke |
| NCT03638908 PAH results posted | NIKK23 STU 082013-045 | Ph 2 | completed | Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial |
| NCT00942708 results posted | STU 052009-009 UL1RR024982 | Ph 2 | completed | Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension |
| NCT02929667 results posted | 201607761 | Ph 2 | completed | Abnormal Ventilatory Response to Carbon Dioxide: a Potential Biomarker for Seizure Induced Respiratory Depression & Modification by SSRI |
| NCT01910259 MS-SMART | 12/0219 | Ph 2 | completed | MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial |
| NCT02017535 PTAD GIA results posted | 1206M15365 | Ph 1, Ph 2 | completed | An Adaptive Treatment Strategy for Adolescent Depression-Continuation |
| NCT04272476 ACUfNIRS | ChengduUTCM | Ph 2 | completed | The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy |
| NCT01687478 results posted | 13702 F1D-CR-HGNB | Ph 3 | terminated | A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression |
| NCT02372799 VLZ-MD-22 results posted | VLZ-MD-22 | Ph 3 | completed | Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22) |
| NCT01802437 PTAD results posted | 1110M05542 | Ph 1, Ph 2 | completed | An Adaptive Treatment Strategy for Adolescent Depression |
| NCT02389712 FLAME results posted | 13-003545-1 UL1TR000135 | Ph 4 | terminated | 16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression |
| NCT01243957 results posted | 12597 H9P-EW-LNCH | Ph 1 | completed | 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. |
| NCT01372150 results posted | B2061014 3151A6-3356, 2008-002063-13 | Ph 3 | completed | A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD |
| NCT00578669 results posted | PHI0710-002 1R01DA023190 | Ph 3 | completed | Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms |
| NCT01360866 Orion results posted | 331-10-238 | Ph 3 | completed | Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) |
| NCT02238977 results posted | 203076 R21DK097470 | Ph 4 | terminated | Bupropion for Depression in ESRD Patients on Hemodialysis |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01714310 results posted | U01MH093582 U01MH093582 | Ph 2 | completed | Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation |
| NCT01824433 | VFPWMDD | Ph 4 | completed | Comparison of Venlafaxine and Fluoxetine in the Treatment of Postmenopausal Women With Major Depression |
Showing 50 of 70 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLUOXETINE FDA Label Details
Indications & Usage
FLUOXETINE is FDA-approved to treat 6 conditions — same approved indications as PROZAC.
Looking for the branded version?
PROZAC WEEKLY
Full clinical data, patents, trials, and competitive landscape for fluoxetine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment