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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/03 | Early Phase 1 | Completed | United States Naval Medical Center, San Diego | ||
2024/06/27 | Phase 4 | Completed | |||
2024/05/30 | Phase 4 | Recruiting | |||
2024/05/10 | Not Applicable | Recruiting | Bruno Minotti | ||
2024/05/03 | Phase 4 | Not yet recruiting | |||
2024/03/19 | Phase 3 | Completed | Lahore Medical Research Center, LLP | ||
2024/02/08 | Phase 1 | Completed | |||
2024/01/31 | Phase 4 | Completed | Second Hospital of Jilin University | ||
2024/01/30 | Phase 2 | Completed | |||
2024/01/19 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| L. Perrigo Company | 0113-0897 | ORAL | 100 mg in 5 mL | 4/30/2025 | |
| PharmPak, Inc. | 54348-830 | ORAL | 600 mg in 1 1 | 10/9/2022 | |
| REMEDYREPACK INC. | 70518-3313 | ORAL | 600 mg in 1 1 | 3/15/2024 | |
| Redpharm Drug, Inc. | 67296-1518 | ORAL | 400 mg in 1 1 | 2/7/2023 | |
| Polygen Pharmaceuticals LLC | 52605-123 | ORAL | 800 mg in 1 1 | 10/20/2011 | |
| Preferred Pharmaceuticals, Inc. | 68788-9110 | ORAL | 400 mg in 1 1 | 7/12/2023 | |
| Haleon US Holdings LLC | 0573-0196 | ORAL | 200 mg in 1 1 | 4/9/2025 | |
| Walgreen Company | 0363-1521 | ORAL | 100 mg in 1 1 | 5/7/2025 | |
| Golden State Medical Supply, Inc. | 51407-370 | ORAL | 600 mg in 1 1 | 2/28/2024 | |
| A-S Medication Solutions | 50090-5437 | ORAL | 600 mg in 1 1 | 5/10/2021 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BIFEN SUSPENSION 100 mg/5 ml | SIN08932P | SUSPENSION | 100 mg/5 ml | 9/20/1996 | |
| YSP IBUPROFEN SUSPENSION 20MG/ML | SIN14161P | SUSPENSION | 20.0mg | 6/18/2012 | |
| SPEDIFEN 400 SACHET 400 mg /sachet | SIN10707P | GRANULE, FOR SOLUTION | 400 mg/sachet | 1/25/1999 | |
| IBUFEN TABLETS 200 mg | SIN05464P | TABLET, FILM COATED | 200 mg | 2/19/1991 | |
| MAXIGESIC PE FILM-COATED TABLET | SIN16703P | TABLET, FILM COATED | 150.0mg | 2/21/2023 | |
| NUROMOL FILM COATED TABLET 200mg/500mg | SIN15200P | TABLET, FILM COATED | 200mg | 3/28/2017 | |
| MAXIGESIC TABLET 500MG/150MG | SIN14648P | TABLET, FILM COATED | 150 MG | 10/23/2014 | |
| NUROFEN EXPRESS CAPLETS 684MG | SIN14367P | TABLET, FILM COATED | 684MG | 6/14/2013 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ibuprofen Effervesent Tablets | 国药准字H19990138 | 化学药品 | 片剂(泡腾) | 3/5/2020 | |
| Ibuprofen Orally Disintegrating Tablets | 国药准字H20052659 | 化学药品 | 片剂 | 3/16/2020 | |
| Ibuprofen Orally Disintegrating Tablets | 国药准字H20090303 | 化学药品 | 片剂 | 7/11/2024 | |
| Ibuprofen Orally Disintegrating Tablets | 国药准字H20052660 | 化学药品 | 片剂 | 3/16/2020 | |
| Ibuprofen for Suspension | 国药准字H10970359 | 化学药品 | 干混悬剂 | 6/19/2020 | |
| Ibuprofen Arginine Granules | 国药准字H20253922 | 化学药品 | 颗粒剂 | 4/15/2025 | |
| Ibuprofen Arginine Granules | 国药准字H20253894 | 化学药品 | 颗粒剂 | 4/15/2025 | |
| Ibuprofen Arginine Granules | 国药准字H20253904 | 化学药品 | 颗粒剂 | 4/15/2025 | |
| Ibuprofen Arginine Granules | 国药准字H20234441 | 化学药品 | 颗粒剂 | 1/10/2024 | |
| Ibuprofen Arginine Granules | 国药准字H20244028 | 化学药品 | 颗粒剂 | 6/18/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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