Ibuprofen clinical trials
Ibuprofen is named as an intervention in 23 current clinical trials in our Egypt, Turkey, Canada, USA, China, Ireland, Australia, Taiwan, France, Spain, Italy, Poland, Switzerland, Norway and Brazil registers. 12 are recruiting patients now. The most common phase is Not applicable. The sponsor with the most trials is Cairo University (2). The most-studied condition is Low Back Pain. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Ibuprofen is approved
All regulators →Of the three regulators tracked here, the first to approve Ibuprofen was the US, on 19 Sep 1974. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age (6 Mar 2001, withdrawn)
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.
Ibuprofen patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ibuprofen, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 16 Mar 2032 (US 9072661).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Ibuprofen
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 Ibuprofen works
All drug targets →- Cyclooxygenase inhibitor InhibitorTarget: Cyclooxygenase✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- Inguinal herniaPhase 3
- Low back painPhase 3
- Neck painPhase 3
- SepsisPhase 3
- ShockPhase 3
- ThrombocytopeniaPhase 3
- Acute kidney injuryPhase 3
- Adult acute respiratory distress syndromePhase 3
- AsthmaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL521, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2713, 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 Ibuprofen
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 76 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Pedea, Vlustozik (previously Ibuprofen Gen.Orph) (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- 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 Ibuprofen
- ChEMBL
- CHEMBL521
- DrugBank
- DB01050
- PubChem CID
- 3672
- CAS number
- 15687-27-1
- FDA UNII
- WK2XYI10QM
- Wikidata
- Q186969
- Wikipedia
- Ibuprofen
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 Ibuprofen
23 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.
Ibuprofen in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ibuprofen. 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 |
|---|---|---|---|---|
|
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis
2026-526538-15-00 · CTIS ↗ · Musculoskeletal Diseases
|
Phase 3 | Authorised | Celltrion Inc | Poland |
|
The headache- and migraine-inducing effects of pitolisant in women with migraine without aura
2026-525521-20-00 · CTIS ↗ · Nervous System Diseases
|
Phase 1 | Authorised | Syddansk Universitet (University of Southern Denmark) | Denmark |
Ibuprofen 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)
76 single-substance products containing Ibuprofen on the HPRA medicines list.
- Actiprofen 200 mg tabletsHaleon Ireland Limited · PA0678/061/002 · Marketed
- Advil Liquid 200mg Soft capsulesHaleon Ireland Limited · PA0678/146/001 · Marketed
- Brufen 400mg film-coated tabletsViatris Healthcare Limited · PA23355/012/001 · Marketed
- Brufen 600mg film-coated tabletsViatris Healthcare Limited · PA23355/012/002 · Marketed
- Brufen Paediatric 100 mg/5 ml Oral SuspensionViatris Healthcare Limited · PA23355/012/003 · Marketed
Supply shortages
No entry for Ibuprofen in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Ibuprofen
43 conditionsAll 43 conditions
| Condition (as registered) | Trials |
|---|---|
| Low Back Pain | 2 |
| Patent Ductus Arteriosus After Premature Birth | 1 |
| Analgesia | 1 |
| Degenerative Arthritis | 1 |
| Electronic Moxibustion | 1 |
| Muscle Hardness | 1 |
| Lumbar Radiculopathy | 1 |
| Lumbar Disc Herniation | 1 |
| Lumbar Disc Disease | 1 |
| Myocarditis Acute | 1 |
| Chronic Granulomatous Disease X-linked (X-CGD) | 1 |
| Pancreatitis, Acute | 1 |
| Pain, Acute | 1 |
| Pancreatic Disease | 1 |
| Pancreatic Diseases | 1 |
| Cancer Pain | 1 |
| Cancer Palliative Care | 1 |
| Obesity, Morbid | 1 |
| Urolithiasis | 1 |
| Kidney Stones | 1 |
| Ureteral Stones | 1 |
| Postoperative Pain | 1 |
| Frozen Shoulder | 1 |
| Adhesive Capsulitis | 1 |
| Shoulder Pain | 1 |
| NSAID (Non-Steroidal Anti-Inflammatory Drug) | 1 |
| Migraine | 1 |
| Analgesic Affect | 1 |
| Emergency Medicine | 1 |
| Tibial Fractures | 1 |
| Pain | 1 |
| Musculoskeletal Injury | 1 |
| Pediatrics | 1 |
| Sprain and Strain of Ankle | 1 |
| Sprain Knee | 1 |
| Osteoarthritis, Knee | 1 |
| Pain and Anxiety in Children With MIH | 1 |
| Primary Dysmenorrhea | 1 |
| Pulp Necrosis, Apical Periodontitis | 1 |
| Neonatal Prematurity | 1 |
| Patent Ductus Arteriosus in Preterm Infants | 1 |
| Prostaglandins | 1 |
| Post Operative Analgesia | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Cairo University | 2 |
| Mount Sinai Hospital, Canada | 1 |
| Heron Therapeutics | 1 |
| Overseas Pharmaceuticals, Ltd | 1 |
| Nanfang Hospital, Southern Medical University | 1 |
| St Joseph University, Beirut, Lebanon | 1 |
| Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III | 1 |
| IRCCS San Raffaele | 1 |
| Medical University of Warsaw | 1 |
| University Hospital, Basel, Switzerland | 1 |
| Norwegian University of Science and Technology | 1 |
| University of Gaziantep | 1 |
| Ataturk University | 1 |
| Konya Beyhekim Training and Research Hospital | 1 |
| Haydarpasa Numune Training and Research Hospital | 1 |
+ 7 more sponsors in the trial list above.
By country register
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 Ibuprofen trials
How many clinical trials are testing Ibuprofen?
23 current trials in our Egypt, Turkey, Canada, USA, China, Ireland, Australia, Taiwan, France, Spain, Italy, Poland, Switzerland, Norway and Brazil registers name Ibuprofen as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Ibuprofen trials recruiting patients?
Yes. 12 of the 23 trials are recruiting: 3 with sites in Egypt, 2 with sites in Turkey, 3 with sites in Canada, 1 with sites in Ireland, 1 with sites in Australia, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Poland and 1 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ibuprofen clinical trials?
Cairo University (2), Mount Sinai Hospital, Canada (1), Heron Therapeutics (1) and Overseas Pharmaceuticals, Ltd (1), among 22 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Ibuprofen clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Ibuprofen licensed in Ireland?
Yes. The HPRA medicines list includes 76 single-substance products containing Ibuprofen, for example Actiprofen 200 mg tablets (Haleon Ireland Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ibuprofen shortage?
Not in the lists we track: Ibuprofen 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 Ibuprofen 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 Ibuprofen 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 Ibuprofen (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.