Product Description
Ibuprofen is a medication used to manage and treat inflammatory diseases, rheumatoid disorders, mild to moderate pain, fever, dysmenorrhea, and osteoarthritis. It is in the non-steroidal anti-inflammatory drug (NSAID) class of medications. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK542299/)
Mechanisms of Action: COX2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | 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 | Japan | 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: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Brazil, China, Denmark, Ireland, Jordan, Mexico, Pakistan, Qatar, Spain, United States
Active Clinical Trial Count: 36
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Pfizer presented Unknown Cross Infection|COVID-19 results on 2025-04-29 for Ibuprofen
Highest Development Phases
Phase 3: Acute Pain|Chronic Pain|Common Cold|Conduct Disorder|Depressive Disorder|Influenza, Human|Labor Pain|Malnutrition|Neuropathic Pain|Osteoarthritis|Pain Unspecified|Pain, Postoperative|Pelvic Pain|Tooth, Impacted
Phase 2: Arthritis|Cellulite|Ductus Arteriosus, Patent|Low Back Pain|Mastoiditis|Osteoarthritis, Knee|Otitis
Phase 1: Bursitis|Headache|Healthy Volunteers|Migraine Disorders|Myalgia|Other|Prostate Cancer|Shoulder Pain|Tenosynovitis|Toothache
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04123717 |
IRB 16206/16 | P1 |
Completed |
Other |
2024-03-07 |
23% |
2024-08-15 |
Primary Endpoints |
CTR20231663 |
CTR20231663 | P1 |
Completed |
Shoulder Pain|Tenosynovitis|Bursitis|Myalgia|Headache|Toothache|Osteoarthritis|Common Cold|Influenza, Human |
2023-12-12 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT06180070 |
NCT06180070 | P1 |
Completed |
Headache|Migraine Disorders |
2023-09-14 |
2023-12-23 |
Primary Endpoints|Treatments |
|
2022-000843-57 |
Study of ibuprofen plus hyoscine butylbromide in patients with primary dysmenorrhoea | P3 |
Active, not recruiting |
Pelvic Pain |
2023-07-02 |
|||
NCT07225140 |
AFT-MX-16p | P3 |
Not yet recruiting |
Acute Pain|Pain, Postoperative |
2026-10-01 |
2025-11-06 |
Primary Endpoints |
|
2023-505687-11-00 |
FMLD-FEBETRADI-53_FI | P3 |
Recruiting |
Acute Pain |
2025-06-30 |
2025-05-02 |
Treatments |
|
NCT06531707 |
SIL-30700-III-23(1) | P3 |
Recruiting |
Common Cold |
2025-01-20 |
12% |
2024-08-02 |
Primary Endpoints|Treatments |
2022-003559-32 |
2022-003559-32 | P3 |
Completed |
Influenza, Human |
2024-12-04 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT06317064 |
LMRC-Aprepitant-Pain-01 | P3 |
Completed |
Chronic Pain|Depressive Disorder|Malnutrition|Neuropathic Pain|Conduct Disorder |
2024-10-31 |
2025-02-22 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
NCT05081102 |
OXIFEN | P3 |
Completed |
Pain, Postoperative|Labor Pain |
2024-05-28 |
14% |
2025-02-15 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05484401 |
NCT05484401 | P3 |
Completed |
Tooth, Impacted |
2023-06-15 |
20% |
2023-06-24 |
|
NCT05742763 |
PRPNSAIDsKOA | P2 |
Recruiting |
Osteoarthritis, Knee|Chronic Pain |
2026-12-31 |
50% |
2024-04-04 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
2023-503209-13-00 |
2023-503209-13-00 | P2 |
Recruiting |
Ductus Arteriosus, Patent |
2026-03-30 |
2025-05-02 |
Treatments |
|
NCT04637529 |
APS003/2020 | P2 |
Completed |
Osteoarthritis |
2023-06-30 |
50% |
2023-07-18 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04772781 |
APS002/2020 | P2 |
Completed |
Low Back Pain|Acute Pain |
2023-05-25 |
69% |
2023-07-18 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2019-000647-27 |
Efficacy and bioavailability of ibuprofen lysinate | P2 |
Active, not recruiting |
Mastoiditis|Arthritis|Otitis|Cellulite |
2021-12-18 |
2022-03-13 |
Treatments |
|
2024-510792-38-00 |
2024-510792-38-00 | P3 |
Withdrawn |
Pain Unspecified |
2029-03-01 |
2025-05-02 |
Treatments |
|
NCT06802185 |
NCT06802185 | P1 |
Completed |
Healthy Volunteers|Pain Unspecified |
2025-04-12 |
88% |
2025-04-24 |
Primary Endpoints|Trial Status |
CTR20244349 |
CTR20244349 | P1 |
Completed |
Healthy Volunteers|Pain Unspecified |
2025-01-05 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
ACTRN12624000087550 |
ACTRN12624000087550 | P1 |
Completed |
Healthy Volunteers|Pain Unspecified |
2024-05-06 |
2024-10-29 |
Primary Completion Date|Start Date|Treatments|Trial Status |
|
NCT05737069 |
NCT05737069 | P1 |
Completed |
Pain Unspecified|Healthy Volunteers |
2023-05-15 |
23% |
2023-06-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2024-517807-35-00 |
FMLD-IOTRA2-47_FIII | P3 |
Completed |
Pain Unspecified |
2025-01-22 |
2025-05-02 |
Treatments |
|
ACTRN12621000694819 |
ACTRN12621000694819 | P3 |
Completed |
Osteoarthritis |
2024-09-06 |
2025-11-20 |
Treatments |
|
2024-510792-38-01 |
2024-510792-38-01 | P3 |
Withdrawn |
Pain Unspecified |
2029-03-01 |
2025-05-02 |
Treatments |
|
NCT07225634 |
AFT-MXIV-08p | P3 |
Not yet recruiting |
Acute Pain |
2026-10-01 |
2025-11-07 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/16/2025 |
News Article |
Glasgow Caledonian University to Lead £2.6m UK Doctoral Training Programme to Tackle Global Oral Health Challenges |
|
12/12/2025 |
News Article |
Haleon Recognized by Fast Company as a 2025 Brands That Matter Honoree |
|
12/08/2025 |
News Article |
CALDOLOR® (IBUPROFEN) INJECTION CMS ISSUED J-CODE NOW ASSOCIATED WITH REIMBURSEMENT PRICE SUPPORTING NON-OPIOID PAIN MANAGEMENT |
|
11/24/2025 |
News Article |
Altibbi Enables Haleon's "Healthy Saudi Smile" Campaign, Turning Oral Health Awareness Into Action |