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 |
|---|---|---|---|---|---|
2018/01/19 | Phase 3 | Completed | |||
2018/01/19 | Phase 4 | Completed | |||
2018/01/16 | Phase 2 | Completed | |||
2017/12/28 | Phase 1 | Withdrawn | |||
2017/12/18 | Phase 4 | UNKNOWN | |||
2017/12/13 | Phase 4 | Completed | |||
2017/11/24 | Not Applicable | Completed | |||
2017/08/29 | Phase 4 | UNKNOWN | |||
2017/08/08 | Early Phase 1 | Withdrawn | Satheesh Elangovan | ||
2017/08/07 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Granules India Limited | 62207-354 | ORAL | 400 mg in 1 1 | 4/24/2023 | |
| Keltman Pharmaceuticals Inc. | 68387-210 | ORAL | 800 mg in 1 1 | 1/3/2011 | |
| Major Pharmaceuticals | 0904-5309 | ORAL | 100 mg in 5 mL | 3/3/2025 | |
| Aidarex Pharmaceuticals LLC | 53217-364 | ORAL | 600 mg in 1 1 | 8/23/2018 | |
| Bi-Coastal Pharma International LLC | 42582-112 | ORAL | 600 mg in 1 1 | 4/18/2016 | |
| Aidarex Pharmaceuticals LLC | 53217-366 | ORAL | 400 mg in 1 1 | 8/21/2018 | |
| Cardinal Health 110, LLC. dba Leader | 70000-0263 | ORAL | 100 mg in 5 mL | 3/3/2025 | |
| MARKSANS PHARMA LIMITED | 25000-121 | ORAL | 400 mg in 1 1 | 2/18/2022 | |
| A-S Medication Solutions | 50090-2626 | ORAL | 600 mg in 1 1 | 3/16/2021 | |
| TIME CAP LABORATORIES, INC | 49483-604 | ORAL | 800 mg in 1 1 | 12/30/2019 |
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 Tablets | 国药准字H53020992 | 化学药品 | 片剂 | 6/24/2020 | |
| Ibuprofen Tablets | 国药准字H23020172 | 化学药品 | 片剂 | 5/18/2020 | |
| Ibuprofen Tablets | 国药准字H44025187 | 化学药品 | 片剂 | 4/1/2020 | |
| Ibuprofen Tablets | 国药准字H61020706 | 化学药品 | 片剂 | 11/20/2020 | |
| Ibuprofen Tablets | 国药准字H15020227 | 化学药品 | 片剂(糖衣) | 7/20/2020 | |
| Ibuprofen Tablets | 国药准字H35020924 | 化学药品 | 片剂（薄膜衣片） | 3/26/2020 | |
| Ibuprofen Tablets | 国药准字H42021408 | 化学药品 | 片剂 | 6/17/2020 | |
| Ibuprofen Tablets | 国药准字H44020057 | 化学药品 | 片剂 | 5/6/2020 | |
| Ibuprofen Tablets | 国药准字H50020032 | 化学药品 | 片剂 | 8/27/2020 | |
| Ibuprofen Tablets | 国药准字H34021671 | 化学药品 | 片剂 | 2/28/2020 |
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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