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 |
|---|---|---|---|---|---|
2022/08/02 | Phase 3 | Completed | |||
2022/07/29 | Not Applicable | UNKNOWN | Yuzuncu Yıl University | ||
2022/06/23 | Phase 1 | Completed | |||
2022/06/02 | Not Applicable | Completed | |||
2022/05/13 | Phase 4 | Recruiting | University Hospital, Akershus | ||
2022/05/02 | N/A | Completed | Nuria Llorach-Perucho | ||
2022/04/22 | Phase 1 | UNKNOWN | |||
2022/04/22 | Phase 2 | Recruiting | |||
2022/04/15 | Phase 1 | Completed | |||
2022/04/13 | Phase 4 | Recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Northwind Pharmaceuticals, LLC | 51655-851 | ORAL | 800 mg in 1 1 | 1/16/2024 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-387 | ORAL | 800 mg in 1 1 | 1/22/2020 | |
| Lake Erie Medical DBA Quality Care Products LLC | 49999-042 | ORAL | 800 mg in 1 1 | 3/20/2019 | |
| RPK Pharmaceuticals, Inc. | 53002-3010 | ORAL | 600 mg in 1 1 | 4/18/2019 | |
| REMEDYREPACK INC. | 70518-0761 | ORAL | 600 mg in 1 1 | 4/28/2025 | |
| Bryant Ranch Prepack | 71335-0690 | ORAL | 400 mg in 1 1 | 3/16/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-2815 | ORAL | 800 mg in 1 1 | 8/19/2022 | |
| Prasco Laboratories | 66993-490 | INTRAVENOUS | 10 mg in 1 mL | 10/31/2023 | |
| AvKARE | 42291-442 | ORAL | 800 mg in 1 1 | 6/1/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-3125 | ORAL | 600 mg in 1 1 | 1/14/2022 |
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 Capsules | 国药准字H14023609 | 化学药品 | 胶囊剂 | 7/28/2020 | |
| Ibuprofen Capsules | 国药准字H21023817 | 化学药品 | 胶囊剂 | 6/4/2020 | |
| Ibuprofen Capsules | 国药准字H36022298 | 化学药品 | 胶囊剂 | 9/23/2021 | |
| Ibuprofen Capsules | 国药准字H14023608 | 化学药品 | 胶囊剂 | 4/10/2020 | |
| Ibuprofen Capsules | 国药准字H21023855 | 化学药品 | 胶囊剂 | 6/19/2020 | |
| Ibuprofen Capsules | 国药准字H23023510 | 化学药品 | 胶囊剂 | 6/29/2020 | |
| Ibuprofen Capsules | 国药准字H21023815 | 化学药品 | 胶囊剂 | 5/12/2020 | |
| Ibuprofen Capsules | 国药准字H21023925 | 化学药品 | 胶囊剂 | 6/1/2020 | |
| Ibuprofen Capsules | 国药准字H44025114 | 化学药品 | 胶囊剂 | 9/28/2020 | |
| Ibuprofen Capsules | 国药准字H65020412 | 化学药品 | 胶囊剂 | 10/16/2020 |
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 |
|---|---|---|---|---|---|
| CHEMISTS’ OWN IBUPROFEN LIQUID CAPSULES 200 mg blister pack | 282022 | Medicine | A | 11/2/2016 | |
| MEDIHEALTH MIGRAINE RELIEF ibuprofen lysine 342 mg tablet blister pack | 192599 | Medicine | A | 12/5/2011 | |
| MEDREICH IBUPROFEN 200mg tablets blister pack | 160247 | Medicine | A | 3/18/2009 | |
| SANDOZ IBUPROFEN PLUS CODEINE film coated tablet blister pack | 211512 | Medicine | A | 6/27/2013 | |
| BLACK & GOLD IBUPROFEN 200 mg sugar coated tablet blister pack | 165316 | Medicine | A | 9/16/2009 | |
| BUTAFEN ibuprofen 200 mg film-coated tablets blister pack | 155484 | Medicine | A | 9/30/2008 | |
| NUROFEN ZAVANCE LIQUID CAPSULES ibuprofen 200mg soft capsule blister pack | 163477 | Medicine | A | 7/17/2009 | |
| COMBIGESIC tablet blister pack | 268812 | Medicine | A | 2/3/2016 | |
| SPIRO LIFECARE IBUPROFEN ibuprofen 200mg softgel capsule | 315483 | Medicine | A | 3/18/2019 | |
| ADMED IBUPROFEN 200 mg film coated tablet blister pack | 407499 | Medicine | A | 4/11/2023 |