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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/02/19 | Not Applicable | Completed | |||
2018/02/19 | Not Applicable | Terminated | |||
2018/02/06 | Not Applicable | Completed | |||
2018/02/01 | Phase 1 | Terminated | |||
2018/01/19 | Phase 3 | Completed | |||
2018/01/19 | Phase 4 | Completed | |||
2018/01/16 | Phase 2 | Completed | |||
2017/12/28 | Phase 1 | Withdrawn | |||
2017/12/18 | Phase 4 | UNKNOWN | |||
2017/12/13 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Biomes Pharmaceuticals LLC | 69150-600 | ORAL | 600 mg in 1 1 | 11/1/2014 | |
| United Natural Foods, Inc. dba UNFI | 41163-897 | ORAL | 100 mg in 5 mL | 5/6/2025 | |
| Major Pharmaceuticals | 0904-5463 | ORAL | 50 mg in 1.25 mL | 5/3/2025 | |
| QPharma Inc | 42708-097 | ORAL | 600 mg in 1 1 | 12/18/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-914 | ORAL | 800 mg in 1 1 | 9/29/2023 | |
| Precision Dose Inc. | 68094-494 | ORAL | 100 mg in 5 mL | 8/8/2025 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-080 | ORAL | 600 mg in 1 1 | 1/14/2021 | |
| Amneal Pharmaceuticals of New York LLC | 53746-466 | ORAL | 800 mg in 1 1 | 12/31/2023 | |
| Chartwell RX, LLC | 62135-402 | ORAL | 800 mg in 1 1 | 10/11/2023 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-5309 | ORAL | 100 mg in 5 mL | 3/31/2025 |
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| No EMA approvals found for this drug. | |||
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| No NMPA approvals found for this drug. | |||||
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CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| PIREXIN 40 mg/ml SUSPENSION ORAL | Laboratorios Ern S.A. | 65503 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUPROFENO (ARGININA) CUVE 600 mg GRANULADO PARA SOLUCION ORAL EFG | Laboratorios Perez Gimenez S.A. | 70405 | GRANULADO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| IBUPROFENO (ARGININA) FARMALID 600 mg GRANULADO PARA SOLUCION ORAL EFG | Farmalider S.A. | 69678 | GRANULADO PARA SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| IBUPROFENO FARMASIERRA 50 mg/ g GEL | Farmasierra Laboratorios S.L. | 63162 | GEL | Sin Receta | Commercialized |
| IBUPROFENO KERN PHARMA 200 mg GRANULADO EFERVESCENTE EFG | 67916 | GRANULADO EFERVESCENTE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| NEOBRUFEN RETARD 800 mg COMPRIMIDOS DE LIBERACION PROLONGADA | 61618 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| IBUPROFENO KERN PHARMA 400 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 65854 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| IBUPROFENO CINFA 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 82158 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| NUROFEN PEDIATRICO 40 MG/ML SUSPENSION ORAL SABOR FRESA | Reckitt Benckiser Healthcare S.A. | 78466 | SUSPENSIÓN ORAL | Sin Receta | Commercialized |
| NUROFEN RAPID 400 mg CAPSULAS BLANDAS | Reckitt Benckiser Healthcare S.A. | 68517 | CÁPSULA BLANDA | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
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