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 |
|---|---|---|---|---|---|
2019/10/01 | Phase 4 | Recruiting | |||
2019/09/25 | Phase 4 | Recruiting | |||
2019/09/12 | Not Applicable | Completed | |||
2019/08/28 | Not Applicable | Completed | Yeşim KAYA | ||
2019/08/16 | Early Phase 1 | Recruiting | |||
2019/07/30 | Phase 3 | UNKNOWN | Máximo Vento Torres | ||
2019/07/19 | Phase 2 | Withdrawn | |||
2019/07/18 | Phase 4 | Completed | Francisco Unda Solano | ||
2019/06/14 | Phase 4 | Completed | |||
2019/06/07 | Phase 2 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| United Natural Foods, Inc. dba UNFI | 41163-685 | ORAL | 100 mg in 5 mL | 4/18/2025 | |
| NuCare Pharmaceuticals, Inc. | 68071-3849 | ORAL | 600 mg in 1 1 | 5/14/2025 | |
| RedPharm Drug, Inc. | 67296-1584 | ORAL | 600 mg in 1 1 | 1/21/2022 | |
| Bryant Ranch Prepack | 63629-8891 | ORAL | 800 mg in 1 1 | 11/24/2021 | |
| Proficient Rx LP | 63187-962 | ORAL | 800 mg in 1 1 | 6/1/2023 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-273 | ORAL | 800 mg in 1 1 | 1/27/2017 | |
| NuCare Pharmaceuticals,Inc. | 68071-2946 | ORAL | 600 mg in 1 1 | 2/28/2023 | |
| Biomes Pharmaceuticals LLC | 69150-800 | ORAL | 800 mg in 1 1 | 11/1/2014 | |
| Target Corporation | 11673-685 | ORAL | 100 mg in 5 mL | 5/7/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-4306 | ORAL | 400 mg in 1 1 | 2/16/2021 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ibuprofen Granules | 国药准字H20083901 | 化学药品 | 颗粒剂 | 8/19/2023 | |
| Ibuprofen Suspension | 国药准字H20253472 | 化学药品 | 口服混悬剂 | 2/25/2025 | |
| Ibuprofen Suspension | 国药准字H20233807 | 化学药品 | 口服混悬剂 | 8/1/2023 | |
| Ibuprofen Suspension | 国药准字H20249373 | 化学药品 | 口服混悬剂 | 11/15/2024 | |
| Ibuprofen Suspension | 国药准字H20243047 | 化学药品 | 口服混悬剂 | 1/9/2024 | |
| Ibuprofen Suspension | 国药准字H20020036 | 化学药品 | 口服混悬剂 | 11/12/2020 | |
| Ibuprofen Suspension | 国药准字H10970354 | 化学药品 | 口服混悬剂 | 7/28/2020 | |
| Ibuprofen Suspension | 国药准字H20223755 | 化学药品 | 口服混悬剂 | 10/11/2022 | |
| Ibuprofen Suspension | 国药准字H20244207 | 化学药品 | 口服混悬剂 | 6/28/2024 | |
| Ibuprofen Suspension | 国药准字H20234456 | 化学药品 | 口服混悬剂 | 10/30/2023 |
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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