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 |
|---|---|---|---|---|---|
2025/08/15 | Not Applicable | Completed | HITEC-Institute of Medical Sciences | ||
2025/08/11 | Not Applicable | Recruiting | |||
2025/08/05 | Not Applicable | Not yet recruiting | Papa Giovanni XXIII Hospital | ||
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 |
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 | |
| Mollec Inc | 82179-006 | ORAL | 100 mg in 5 mL | 8/12/2025 | |
| 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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CHILDREN'S ADVIL COLD | glaxosmithkline consumer healthcare ulc | 02248435 | Suspension - Oral | 100 MG / 5 ML | 8/9/2004 |
| CHILDREN'S ADVIL | glaxosmithkline consumer healthcare ulc | 02232297 | Suspension - Oral | 100 MG / 5 ML | 11/3/1997 |
| ADVIL COLD & FLU | glaxosmithkline consumer healthcare ulc | N/A | Tablet - Oral | 200 MG | 10/27/2011 |
| ADVIL COLD & SINUS PLUS | haleon canada ulc | N/A | Tablet - Oral | 200 MG | 8/2/2004 |
| ADVIL COLD, SINUS & FLU EXTRA STRENGTH | haleon canada ulc | 02471604 | Tablet - Oral | 400 MG | 8/17/2018 |
| MOTRIN LIQUID GELS 400 MG | mcneil consumer healthcare division of johnson & johnson inc | 02378310 | Capsule - Oral | 400 MG | 7/30/2012 |
| CHILDREN'S MOTRIN CHEWABLE TABLET 50MG | mcneil consumer healthcare division of johnson & johnson inc | 02243178 | Tablet - Oral | 50 MG | 2/12/2001 |
| EXTRA STRENGTH IBUPROFEN | vita health products inc | 02268779 | Tablet - Oral | 400 MG | N/A |
| IBUPROFEN EXTRA STRENGTH CAPLETS | vita health products inc | 02368099 | Tablet - Oral | 400 MG | 8/5/2011 |
| IBUPROFEN CAPLETS 200 MG | vita health products inc | 02272857 | Tablet - Oral | 200 MG | 4/7/2006 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| IBUPROFENO CLOVER 200 MG CAPSULAS BLANDAS | Hc Clover Productos Y Servicios S.L. | 80987 | CÁPSULA BLANDA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| IBUDOL PEDIATRICO 20 MG/ML SUSPENSION ORAL | 86016 | SUSPENSIÓN ORAL | Sin Receta | Commercialized | |
| IBUPROFENO GINELADIUS 600 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Gineladius S.L. | 67069 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| IBUPROFENO ZENTIVA 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Zentiva Spain S.L. | 85936 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUCOD 200 MG/ML + 10 MG/ML SOLUCION ORAL | Farmalider S.A. | 76469 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| IBLASIN 40 MG/ML SUSPENSION ORAL | 66028 | SUSPENSIÓN ORAL | Sin Receta | Not Commercialized | |
| IBUFARMALID 200 mg SUSPENSION ORAL | Farmalider S.A. | 67963 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUKERN 600 MG SUSPENSION ORAL | 67930 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| IBUDOL 400 MG SUSPENSION ORAL | 68194 | SUSPENSIÓN ORAL | Sin Receta | Commercialized | |
| IBUPROFENO FARMALIDER 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Farmalider S.A. | 82897 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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