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.
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
Research Report
A Comprehensive Monograph on Ibuprofen (DB01050): From Molecular Mechanisms to Clinical Application and Synthesis
I. Introduction and Historical Context: The Genesis of a Modern Analgesic
Ibuprofen stands as one of the most widely used pharmaceutical agents in modern medicine, a cornerstone of pain and inflammation management available in both prescription and over-the-counter formulations worldwide. Its journey from a laboratory compound to a household name is a compelling narrative of targeted drug discovery, evolving pharmacological understanding, and the perpetual quest for a balance between efficacy and safety. Classified as a non-steroidal anti-inflammatory drug (NSAID), Ibuprofen functions as a non-narcotic analgesic, an anti-inflammatory agent, and an antipyretic.[1] Chemically, it is the prototypical member of the propionic acid class of NSAIDs, a group of compounds that share a common structural and mechanistic heritage.[1]
A. The Quest for a Safer Aspirin
The development of Ibuprofen was not a product of serendipity but of a deliberate and focused research program initiated in 1953 at the Boots Pure Drug Company Ltd. in Nottingham, UK.[4] The project was led by pharmacologist Dr. Stewart Adams, who was tasked with a clear and challenging objective: to discover a novel therapeutic agent for rheumatoid arthritis (RA) that possessed potent anti-inflammatory properties but was devoid of the significant adverse effects associated with the two main therapies of the era—corticosteroids and aspirin.[4]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/29 | Phase 3 | Completed | Zitelli & Brodland Skin Cancer Center | ||
2025/04/22 | Not Applicable | Recruiting | |||
2025/04/02 | Phase 4 | Completed | |||
2025/02/05 | Early Phase 1 | Completed | |||
2025/01/22 | Phase 4 | Active, not recruiting | Haydarpasa Numune Training and Research Hospital | ||
2025/01/17 | Phase 4 | Recruiting | Universidad Europea de Madrid | ||
2025/01/16 | Phase 4 | Recruiting | Universidad Europea de Madrid | ||
2025/01/03 | Phase 4 | Recruiting | |||
2024/12/12 | Phase 3 | Completed | |||
2024/11/13 | Phase 3 | Active, not recruiting | Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Quality Care Products LLC | 55700-445 | ORAL | 600 mg in 1 1 | 10/28/2019 | |
| Preferred Pharmaceuticals, Inc. | 68788-7745 | ORAL | 400 mg in 1 1 | 7/13/2023 | |
| CVS Pharmacy | 69842-706 | ORAL | 100 mg in 1 1 | 5/20/2025 | |
| NuCare Pharmaceuticals,Inc. | 68071-5066 | ORAL | 600 mg in 1 1 | 2/19/2021 | |
| CVS | 51316-914 | ORAL | 100 mg in 5 mL | 5/1/2025 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-186 | ORAL | 800 mg in 1 1 | 2/6/2024 | |
| Asclemed USA, Inc. | 76420-577 | ORAL | 800 mg in 1 1 | 10/6/2023 | |
| Amneal Pharmaceuticals of New York LLC | 53746-132 | ORAL | 600 mg in 1 1 | 12/31/2023 | |
| L. Perrigo Company | 0113-2461 | ORAL | 100 mg in 1 1 | 5/7/2025 | |
| RedPharm Drug, Inc. | 67296-1581 | ORAL | 600 mg in 1 1 | 1/13/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/16/2024 | ||
Authorised | 7/28/2004 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ZOFEN TABLET 200 mg (Orange) | SIN07849P | TABLET, FILM COATED | 200 mg | 9/17/1994 | |
| APO-IBUPROFEN-FC TABLET 400 mg | SIN06017P | TABLET, FILM COATED | 400 mg | 6/3/1991 | |
| NUROFEN EXPRESS LIQUID CAPSULE 200MG | SIN14562P | CAPSULE, LIQUID FILLED | 200mg | 6/23/2014 | |
| NUROFEN TABLET 400MG | SIN14587P | TABLET, SUGAR COATED | 400mg | 8/13/2014 | |
| NUROFEN FOR CHILDREN 200MG/5ML | SIN14958P | SYRUP | 200mg/5mL | 2/19/2016 | |
| BIFEN SUSPENSION 100 mg/5 ml (OTC Pack) | SIN11949P | SUSPENSION | 100 mg/5 ml | 5/23/2002 | |
| NUROFEN TABLET 200MG (OTC) | SIN09488P | TABLET, SUGAR COATED | 200 mg | 9/6/1997 | |
| NUROFEN FOR CHILDREN 100 mg/5 ml (OTC Pack) | SIN11880P | SYRUP | 100 mg/5 ml | 4/17/2002 | |
| MAXIGESIC IV SOLUTION FOR INFUSION 1000MG/300MG PER 100ML VIAL | SIN16507P | INFUSION, SOLUTION | 300mg | 6/3/2022 | |
| BRUFEN Suspension 100 mg/5 ml | SIN05443P | SYRUP | 100 mg/5 ml | 2/19/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ibuprofen Orally Disintegrating Tablets | 国药准字H20060240 | 化学药品 | 片剂 | 6/5/2020 | |
| Ibuprofen Suspension Drops | 国药准字H20253734 | 化学药品 | 口服混悬剂 | 3/25/2025 | |
| Ibuprofen Suspension Drops | 国药准字H20244532 | 化学药品 | 口服混悬剂 | 7/30/2024 | |
| Ibuprofen Suspension Drops | 国药准字H20249319 | 化学药品 | 口服混悬剂 | 11/15/2024 | |
| Ibuprofen Suspension Drops | 国药准字H20249667 | 化学药品 | 口服混悬剂 | 12/1/2024 | |
| Ibuprofen Suspension Drops | 国药准字H20223972 | 化学药品 | 口服混悬剂 | 12/30/2022 | |
| Ibuprofen Suspension Drops | 国药准字H20249217 | 化学药品 | 滴剂 | 10/29/2024 | |
| Ibuprofen Suspension Drops | 国药准字H10980250 | 化学药品 | 滴剂 | 1/13/2020 | |
| Ibuprofen Suspension Drops | 国药准字H19991012 | 化学药品 | 滴剂 | 5/30/2024 | |
| Ibuprofen Suspension Drops | 国药准字H20254095 | 化学药品 | 口服混悬剂 | 5/13/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ADVIL LIQUID CAPSULES 200MG | N/A | N/A | N/A | 11/29/2012 | |
| NUROFEN FOR CHILDREN SYRUP 100MG/5ML | N/A | N/A | N/A | 8/21/2009 | |
| ELOKWEI IBUPROFEN ORAL SUSPENSION 100MG/5ML | N/A | N/A | N/A | 3/11/2025 | |
| IBUPROFEN SHOU CHAN TABLETS 400MG | N/A | N/A | N/A | 5/9/2025 | |
| IPUTON ORAL SUSPENSION 100MG/5ML | N/A | N/A | N/A | 3/11/2025 | |
| MAXIGESIC TABLETS | N/A | N/A | N/A | 3/14/2018 | |
| U-IBUPROFEN TAB 200MG | N/A | N/A | N/A | 4/13/1987 | |
| P-FEN 400 TABLETS 400MG | N/A | N/A | N/A | 9/5/2016 | |
| KORUS IBUPROFEN TABLET 400MG | N/A | N/A | N/A | 12/19/2011 |
TGA Drug Approvals
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