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 |
|---|---|---|---|---|---|
2024/11/04 | Phase 4 | Recruiting | |||
2024/09/19 | Not Applicable | Active, not recruiting | Arooj Khan | ||
2024/09/13 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2024/08/28 | Not Applicable | Completed | |||
2024/08/20 | Phase 4 | Completed | Ankara Etlik City Hospital | ||
2024/08/06 | N/A | Recruiting | |||
2024/08/01 | Phase 3 | Recruiting | |||
2024/07/17 | Phase 4 | Not yet recruiting | |||
2024/07/11 | Phase 4 | Recruiting | Cape Fear Valley Health System | ||
2024/07/11 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| QPharma Inc | 42708-175 | ORAL | 600 mg in 1 1 | 6/7/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-4908 | ORAL | 400 mg in 1 1 | 2/18/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4305 | ORAL | 600 mg in 1 1 | 2/16/2021 | |
| RedPharm Drug, Inc. | 67296-1217 | ORAL | 400 mg in 1 1 | 1/20/2022 | |
| A-S Medication Solutions | 50090-6886 | ORAL | 800 mg in 1 1 | 5/10/2021 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-130 | ORAL | 400 mg in 1 1 | 1/14/2021 | |
| Dolgencorp Inc | 55910-897 | ORAL | 100 mg in 5 mL | 4/28/2025 | |
| Horizon Therapeutics USA, Inc. | 75987-010 | ORAL | 800 mg in 1 1 | 5/6/2021 | |
| Legacy Pharmaceutical Packaging, LLC | 68645-562 | ORAL | 600 mg in 1 1 | 12/13/2023 | |
| DISCOUNT DRUG MART, INC. | 53943-212 | ORAL | 200 mg in 1 1 | 5/27/2025 |
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 |
|---|---|---|---|---|---|
| B. BRAUN IBUPROFEN SOLUTION FOR INFUSION 4MG/ML | SIN16467P | INFUSION, SOLUTION | 4mg/ml | 4/4/2022 | |
| NUROFEN EXPRESS LIQUID CAPSULE 400mg | SIN14561P | CAPSULE, LIQUID FILLED | 400mg | 6/19/2014 | |
| YSP IBUPROFEN FILM COATED TABLET 400 mg | SIN07892P | TABLET, FILM COATED | 400 mg | 10/24/1994 | |
| PEROFEN 200 TABLET 200 mg | SIN06793P | TABLET, SUGAR COATED | 200 mg | 1/21/1992 | |
| NUROFEN EXPRESS CAPLETS 342MG | SIN14366P | TABLET, FILM COATED | 342mg | 6/14/2013 | |
| Spedifen Film Coated Tablet 400mg | SIN14169P | TABLET, FILM COATED | 400mg | 6/21/2012 | |
| APO-IBUPROFEN-FC TABLET 200 mg | SIN06016P | TABLET, FILM COATED | 200 mg | 6/3/1991 | |
| NUROFEN FOR CHILDREN 100mg/5ml (PROFESSIONAL PACK) | SIN15309P | SYRUP | 100mg/5ml | 7/31/2017 | |
| BRUFEN TABLET 200 mg | SIN05722P | TABLET, SUGAR COATED | 200 mg | 4/8/1991 | |
| BRAVEX PAEDIATRIC SUSPENSION 100MG/5ML | SIN15828P | SUSPENSION | 100mg/5ml | 10/9/2019 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ibuprofen Suspension Drops | 国药准字H20254094 | 化学药品 | 口服混悬剂 | 5/13/2025 | |
| Ibuprofen Suspension Drops | 国药准字H20254258 | 化学药品 | 口服混悬剂 | 5/27/2025 | |
| Ibuprofen Arginine Powder | 国药准字H20080400 | 化学药品 | 散剂 | 1/29/2023 | |
| Ibuprofen Gel | 国药准字H20057035 | 化学药品 | 凝胶剂 | 6/16/2020 | |
| Ibuprofen Gel | 国药准字H10970093 | 化学药品 | 凝胶剂 | 7/29/2020 | |
| Pediatric Ibuprofen Suppositories | 国药准字H20133068 | 化学药品 | 栓剂 | 1/5/2023 | |
| Pediatric Ibuprofen Suppositories | 国药准字H20113516 | 化学药品 | 栓剂 | 11/17/2021 | |
| Pediatric Ibuprofen Suppositories | 国药准字H10930050 | 化学药品 | 栓剂 | 8/6/2020 | |
| Pediatric Ibuprofen Suppositories | 国药准字H10930049 | 化学药品 | 栓剂 | 8/6/2020 | |
| Ibuprofen Arginine Tablets | 国药准字H20110028 | 化学药品 | 片剂 | 1/11/2021 |
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 |
|---|---|---|---|---|---|
| MEDIX IBUPROFEN 200 mg tablet blister pack | 314244 | Medicine | A | 2/14/2019 | |
| CHEMISTS’ OWN IBUPROFEN TABLETS 200mg blister pack (new formulation) | 339258 | Medicine | A | 7/9/2020 | |
| AROFEN 12 HOUR EXTENDED RELEASE TABLET ibuprofen 600 mg blister pack | 406177 | Medicine | A | 3/14/2023 | |
| PHARMACY CHOICE IBUPROFEN DOUBLE STRENGTH ibuprofen 400 mg film-coated tablet blister pack | 397975 | Medicine | A | 10/18/2022 | |
| APOHEALTH IBUPROFEN DOUBLE STRENGTH 400 ibuprofen 400 mg film-coated tablet blister pack | 396910 | Medicine | A | 10/4/2022 | |
| IBUFOUND COLD & FLU film-coated tablet blister pack | 450785 | Medicine | A | 6/4/2024 | |
| BUGESIC ORAL SUSPENSION ibuprofen 20mg/mL oral liquid bottle | 80886 | Medicine | A | 11/15/2001 | |
| ADVIL INFANT 3 MONTHS - 2 YEARS PAIN & FEVER RELIEF ibuprofen 40 mg/mL oral liquid suspension bottle | 178432 | Medicine | A | 12/15/2010 | |
| GOFEX 200 CLEARCAP ibuprofen 200 mg soft capsule blister pack | 185416 | Medicine | A | 6/16/2011 | |
| ZENIFEN ibuprofen 200mg tablet blister pack | 346883 | Medicine | A | 10/30/2020 |