Overview
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid and it is considered the first of the propionics. The formula of ibuprofen is 2-(4-isobutylphenyl) propionic acid and its initial development was in 1960 while researching for a safer alternative for aspirin. Ibuprofen was finally patented in 1961 and this drug was first launched against rheumatoid arthritis in the UK in 1969 and USA in 1974. It was the first available over-the-counter NSAID. On the available products, ibuprofen is administered as a racemic mixture. Once administered, the R-enantiomer undergoes extensive interconversion to the S-enantiomer in vivo by the activity of the alpha-methylacyl-CoA racemase. In particular, it is generally proposed that the S-enantiomer is capable of eliciting stronger pharmacological activity than the R-enantiomer.
Background
Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid and it is considered the first of the propionics. The formula of ibuprofen is 2-(4-isobutylphenyl) propionic acid and its initial development was in 1960 while researching for a safer alternative for aspirin. Ibuprofen was finally patented in 1961 and this drug was first launched against rheumatoid arthritis in the UK in 1969 and USA in 1974. It was the first available over-the-counter NSAID. On the available products, ibuprofen is administered as a racemic mixture. Once administered, the R-enantiomer undergoes extensive interconversion to the S-enantiomer in vivo by the activity of the alpha-methylacyl-CoA racemase. In particular, it is generally proposed that the S-enantiomer is capable of eliciting stronger pharmacological activity than the R-enantiomer.
Indication
Ibuprofen is the most commonly used and prescribed NSAID. It is a very common over-the-counter medication widely used as an analgesic, anti-inflammatory and antipyretic. The use of ibuprofen and its enantiomer Dexibuprofen in a racemic mix is common for the management of mild to moderate pain related to dysmenorrhea, headache, migraine, postoperative dental pain, spondylitis, osteoarthritis, rheumatoid arthritis, and soft tissue disorder. Due to its activity against prostaglandin and thromboxane synthesis, ibuprofen has been attributed to alteration of platelet function and prolongation of gestation and labour. As ibuprofen is a widely used medication, the main therapeutic indications are:
Associated Conditions
- Acute Pain
- Ankylosing Spondylitis (AS)
- Common Cold
- Cystic Fibrosis (CF)
- Fever
- Gastric Ulcer
- Gout
- Headache
- Insomnia
- Juvenile Idiopathic Arthritis (JIA)
- Menstrual Distress (Dysmenorrhea)
- Migraine
- Mild pain
- Nasal Congestion
- Osteoarthritis (OA)
- Pain
- Pain, Inflammatory
- Patent Ductus Arteriosus (PDA)
- Pericarditis
- Primary Dysmenorrhoea
- Rheumatoid Arthritis
- Severe Pain
- Sinus pressure
- Mild to moderate pain
- Minor aches and pains
- Moderate Pain
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/25 | Phase 3 | UNKNOWN | |||
2020/01/13 | Not Applicable | Completed | University Hospital Ostrava | ||
2019/12/18 | Not Applicable | Completed | |||
2019/12/17 | Not Applicable | Completed | |||
2019/11/08 | Phase 3 | Terminated | |||
2019/10/21 | Phase 3 | Completed | IRCCS Burlo Garofolo | ||
2019/10/16 | Phase 4 | Recruiting | |||
2019/10/11 | Early Phase 1 | Completed | |||
2019/10/11 | Phase 4 | Completed | |||
2019/10/08 | Phase 4 | Completed | Francisco Unda Solano |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Wal-Mart Stores Inc | 49035-897 | ORAL | 100 mg in 5 mL | 3/3/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-2948 | ORAL | 800 mg in 1 1 | 2/28/2023 | |
| Walgreens | 0363-0749 | ORAL | 200 mg in 1 1 | 5/7/2025 | |
| Wal-Mart Stores Inc | 49035-660 | ORAL | 100 mg in 5 mL | 5/23/2025 | |
| DISCOUNT DRUG MART | 53943-111 | ORAL | 200 mg in 1 1 | 5/15/2025 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-198 | ORAL | 800 mg in 1 1 | 8/4/2023 | |
| Preferred Pharmaceuticals Inc. | 68788-8354 | ORAL | 600 mg in 1 1 | 2/10/2023 | |
| CVS | 51316-131 | ORAL | 125 mg in 1 1 | 5/2/2025 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0243 | ORAL | 800 mg in 1 1 | 1/12/2023 | |
| EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-716 | ORAL | 100 mg in 5 mL | 3/3/2025 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ibuprofen Granules | 国药准字H20055226 | 化学药品 | 颗粒剂 | 8/17/2020 | |
| Ibuprofen Granules | 国药准字H20247140 | 化学药品 | 颗粒剂 | 6/26/2024 | |
| Ibuprofen Granules | 国药准字H20094230 | 化学药品 | 颗粒剂 | 11/12/2019 | |
| Ibuprofen Granules | 国药准字H20066208 | 化学药品 | 颗粒剂 | 12/7/2020 | |
| Ibuprofen Granules | 国药准字H20094113 | 化学药品 | 颗粒剂 | 7/17/2024 | |
| Ibuprofen Granules | 国药准字H20133069 | 化学药品 | 颗粒剂 | 11/24/2022 | |
| Ibuprofen Granules | 国药准字H20204031 | 化学药品 | 颗粒剂 | 5/25/2020 | |
| Ibuprofen Granules | 国药准字H20066209 | 化学药品 | 颗粒剂 | 12/7/2020 | |
| Ibuprofen Granules | 国药准字H10950286 | 化学药品 | 颗粒剂 | 8/11/2020 | |
| Ibuprofen Granules | 国药准字H20205037 | 化学药品 | 颗粒剂 | 10/16/2024 |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.