Fluoxetine clinical trials
Fluoxetine is named as an intervention in 11 current clinical trials in our China, Brazil, Egypt, India, Poland, Norway and Turkey registers. 10 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Tanta University (2). The most-studied condition is Depression. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Fluoxetine is approved
All regulators →Of the three regulators tracked here, the first to approve Fluoxetine was the US, on 29 Dec 1987. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Fluoxetine
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Fluoxetine works
All drug targets →- Serotonin transporter inhibitor InhibitorTarget: SLC6A4 solute carrier family 6 member 4✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Anxiety disorderPhase 3
- AutismPhase 3
- Bipolar disorderPhase 3
- EnuresisPhase 3
- Generalized anxiety disorderPhase 3
- Intracerebral hemorrhagePhase 3
- Nicotine dependencePhase 3
- Post-traumatic stress disorderPhase 3
- Premenstrual tensionPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL41, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 203, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Fluoxetine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 11 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Fluoxetine
- ATC code
- N06AB03
- ChEMBL
- CHEMBL41
- DrugBank
- DB00472
- PubChem CID
- 3386
- CAS number
- 54910-89-3
- FDA UNII
- 01K63SUP8D
- Wikidata
- Q422244
- Wikipedia
- Fluoxetine
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Fluoxetine
11 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Fluoxetine in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Fluoxetine. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Randomized double-blinded placebo-controlled study of the efficacy of fluoxetine in add-on treatment of drug-resistant, complex and rare epilepsy in children aged 8 years and older: use of a design evaluating the time to reach a defined number of seizures for each child during the prospective observational phase (FLUOXEPIL)
2024-519897-38-01 · Nervous System Diseases
|
Phase 3 | Authorised | Centre Hospitalier Regional De Marseille | France |
Fluoxetine across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
11 single-substance products containing Fluoxetine on the HPRA medicines list.
- Fluoxetine 20 mg/ 5 ml Oral SolutionSyri Pharma Limited t/a Thame Laboratories · PA22697/010/001 · Marketed
- Fluzac 20mg CapsulesRowex Limited, · PA0711/110/001 · Marketed
- Prozamel 20 mg Capsules, HardClonmel Healthcare Ltd · PA0126/110/001 · Marketed
- ProzacClear Pharmacy · DPR1596/008/001
- Fluoxetine 10 mg hard capsuleActivase Pharmaceuticals Limited · PA1567/007/001 · Not marketed
Supply shortages
No entry for Fluoxetine in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Fluoxetine
17 conditionsAll 17 conditions
| Condition (as registered) | Trials |
|---|---|
| Depression | 3 |
| Depressive Disorder | 2 |
| Fluoxetine | 2 |
| Hepatobiliary Malignancy | 1 |
| Anxiety Disorders | 1 |
| Depression Disorders | 1 |
| Constipation - Functional | 1 |
| Refractory Constipation | 1 |
| fMRI | 1 |
| Sequestra | 1 |
| Depression - Major Depressive Disorder | 1 |
| Depressive Episodes | 1 |
| Obesity, Morbid | 1 |
| Healthy | 1 |
| Major Depressive Disorder (MDD) | 1 |
| COVID-19 | 1 |
| Depressive Disorder, Major | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Tanta University | 2 |
| Harvard Medical School (HMS and HSDM) | 1 |
| First Affiliated Hospital of Wenzhou Medical University | 1 |
| Xijing Hospital of Digestive Diseases | 1 |
| First Affiliated Hospital of Chongqing Medical University | 1 |
| Poznan University of Medical Sciences | 1 |
| Norwegian University of Science and Technology | 1 |
| Mehmet Kemal Arikan | 1 |
| Federal University of Latin American Integration | 1 |
| University of Oxford | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 3 | 3 |
| Clinical trials in Brazil | 2 | 2 |
| Clinical trials in Egypt | 2 | 2 |
| Clinical trials in India | 1 | 0 |
| Clinical trials in Poland | 1 | 1 |
| Clinical trials in Norway | 1 | 1 |
| Clinical trials in Turkey | 1 | 1 |
| EU register (CTIS) | 1 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Fluoxetine trials
How many clinical trials are testing Fluoxetine?
11 current trials in our China, Brazil, Egypt, India, Poland, Norway and Turkey registers name Fluoxetine as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Fluoxetine trials recruiting patients?
Yes. 10 of the 11 trials are recruiting: 3 with sites in China, 2 with sites in Brazil, 2 with sites in Egypt, 1 with sites in Poland, 1 with sites in Norway and 1 with sites in Turkey. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Fluoxetine clinical trials?
Tanta University (2), Harvard Medical School (HMS and HSDM) (1), First Affiliated Hospital of Wenzhou Medical University (1) and Xijing Hospital of Digestive Diseases (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Fluoxetine licensed in Ireland?
Yes. The HPRA medicines list includes 11 single-substance products containing Fluoxetine, for example Fluoxetine 20 mg/ 5 ml Oral Solution (Syri Pharma Limited t/a Thame Laboratories). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Fluoxetine shortage?
Not in the lists we track: Fluoxetine has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Fluoxetine works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Fluoxetine works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Fluoxetine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.