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 |
|---|---|---|---|---|---|
2017/01/11 | Phase 1 | Completed | SocraTec R&D GmbH | ||
2017/01/10 | Phase 4 | UNKNOWN | Muharrem Ucar | ||
2017/01/05 | Not Applicable | Completed | |||
2017/01/04 | Not Applicable | Completed | |||
2016/12/26 | Phase 3 | Completed | |||
2016/11/28 | Phase 1 | Completed | |||
2016/11/28 | Phase 1 | Completed | |||
2016/11/28 | Not Applicable | Completed | Instituto Brasileiro de Osteopatia | ||
2016/11/15 | Phase 1 | Completed | |||
2016/10/18 | Not Applicable | Completed | USDA, Western Human Nutrition Research Center |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-2432 | ORAL | 400 mg in 1 1 | 2/29/2024 | |
| Meijer Distribution Inc | 41250-897 | ORAL | 100 mg in 5 mL | 4/27/2025 | |
| Major Pharmaceuticals | 0904-5854 | ORAL | 600 mg in 1 1 | 12/21/2022 | |
| Walgreen Company | 0363-0050 | ORAL | 200 mg in 1 1 | 6/23/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-2942 | ORAL | 100 mg in 5 mL | 2/20/2023 | |
| DIRECT RX | 61919-296 | ORAL | 200 mg in 1 1 | 10/27/2016 | |
| Altura Pharmaceuticals, Inc. | 63874-324 | ORAL | 600 mg in 1 1 | 4/28/2010 | |
| CVS Pharmacy | 59779-897 | ORAL | 100 mg in 5 mL | 4/29/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-5059 | ORAL | 400 mg in 1 1 | 2/19/2021 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-629 | ORAL | 600 mg in 1 1 | 1/27/2022 |
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H14021983 | 化学药品 | 片剂(薄膜衣) | 9/9/2020 | |
| Ibuprofen Tablets | 国药准字H36021085 | 化学药品 | 片剂 | 7/8/2021 | |
| Ibuprofen Tablets | 国药准字H50021351 | 化学药品 | 片剂 | 8/3/2020 | |
| Ibuprofen Tablets | 国药准字H22022534 | 化学药品 | 片剂 | 3/11/2020 | |
| Ibuprofen Tablets | 国药准字H61020216 | 化学药品 | 片剂 | 11/24/2022 | |
| Ibuprofen Tablets | 国药准字H43020920 | 化学药品 | 片剂 | 12/12/2019 | |
| Ibuprofen Tablets | 国药准字H32022958 | 化学药品 | 片剂 | 7/14/2020 | |
| Ibuprofen Tablets | 国药准字H45020313 | 化学药品 | 片剂 | 9/1/2020 | |
| Ibuprofen Tablets | 国药准字H46020065 | 化学药品 | 片剂 | 9/16/2020 | |
| Ibuprofen Tablets | 国药准字H44023997 | 化学药品 | 片剂 | 9/28/2020 |
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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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DEEP RELIEF ibuprofen 50mg/g gel tube | 47447 | Medicine | A | 12/8/1993 | |
| PRICELINE PHARMACY PARACETAMOL AND IBUPROFEN tablet blister pack (new formulation) | 354012 | Medicine | A | 2/1/2021 | |
| NUROFEN FOR CHILDREN 5-12 YEARS ORANGE FLAVOUR ibuprofen 40 mg/mL oral suspension | 167734 | Medicine | A | 12/22/2009 | |
| WOOLWORTHS SELECT IBUPROFEN 200 mg tablet blister pack | 132887 | Medicine | A | 11/9/2006 | |
| A-IBUPROFEN 200mg film coated tablets blister pack | 161314 | Medicine | A | 4/24/2009 | |
| HERRON BLUE ibuprofen 200mg film coated tablet bottle | 129739 | Medicine | A | 7/27/2006 | |
| COLES IBUPROFEN 200 mg capsule-shaped, sugar-coated tablet blister pack | 281343 | Medicine | A | 10/13/2016 | |
| RAFEN GEL CAPSULES ibuprofen 200 mg capsules blister pack | 230365 | Medicine | A | 11/11/2014 | |
| APOHEALTH IBUPROFEN PLUS PARACETAMOL film coated tablet blister pack | 277635 | Medicine | A | 7/11/2016 | |
| MEDIX IBUPROFEN 200 mg mini capsules bottle | 209600 | Medicine | A | 5/16/2013 |