Ibuprofen

Generic Name: Ibuprofen

Brand Names: Addaprin, Advil, Advil Cold and Sinus, Advil Congestion Relief, Advil PM, Advil Sinus Congestion and Pain, Alivio, Caldolor, Cedaprin, Children's Ibuprofen, Diphen, Duexis, Ibu, Ibutab, Junior Strength Motrin, Motrin, Motrin PM, Neoprofen, Nuprin, Pedea, Proprinal, Reprexain, Sudafed PE Head Congestion Plus Pain, Vicoprofen, Wal-profen Congestion Relief and Pain, Ibuprofen Gen.Orph

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₈O_₂

CAS Number: 15687-27-1

Unique Ingredient Identifier: WK2XYI10QM

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

Associated Therapies: -

Clinical Trials

Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection

Phase 3

Terminated

Conditions: Infection

Interventions: Drug: Ibuprofen
Drug: Placebo

First Posted Date: 2009-12-18

Last Posted Date: 2012-08-21

Lead Sponsor: Pfizer

Target Recruit Count: 16

Registration Number: NCT01035346

Locations: 🇺🇸
Pfizer Investigational Site, Salt Lake City, Utah, United States

Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain

Phase 3

Completed

Conditions: Low Back Pain

Interventions: Drug: Ibuprofen
Drug: Placebo
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

First Posted Date: 2009-12-09

Last Posted Date: 2009-12-09

Lead Sponsor: Bayer

Target Recruit Count: 338

Registration Number: NCT01028079

Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Phase 3

Completed

Conditions: Fever

Interventions: Drug: ibuprofen
Drug: acetaminophen

First Posted Date: 2009-10-27

Last Posted Date: 2016-11-06

Lead Sponsor: Cumberland Pharmaceuticals

Target Recruit Count: 118

Registration Number: NCT01002573

Locations: 🇺🇸
Staten Island University Hospital, Staten Island, New York, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇺🇸
Children's Memorial Hermann Hospital, Houston, Texas, United States

and more 14 locations

Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion

Phase 3

Completed

Conditions: Pain
Pregnancy

Interventions: Drug: ibuprofen

First Posted Date: 2009-10-16

Last Posted Date: 2012-02-17

Lead Sponsor: Sheba Medical Center

Target Recruit Count: 61

Registration Number: NCT00997074

Locations: 🇮🇱
Sheba Medical Center, Tel Aviv, Israel

To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients

Phase 2

Completed

Conditions: Postoperative Pain

Interventions: Drug: SAF312A
Drug: Placebo
Drug: Ibuprofen

First Posted Date: 2009-09-30

Last Posted Date: 2020-12-19

Lead Sponsor: Novartis

Target Recruit Count: 183

Registration Number: NCT00986882

Locations: 🇺🇸
Jean Brown Research, Salt Lake City, Utah, United States

Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: ICA-105665
Drug: Placebo
Drug: Ibuprofen

First Posted Date: 2009-08-20

Last Posted Date: 2012-09-28

Lead Sponsor: Pfizer

Target Recruit Count: 25

Registration Number: NCT00962663

Locations: Pfizer Investigational Site

Ibuprofen as a Possible Preventer of Post Bronchoscopy Fever

Phase 2

Completed

Conditions: Post Bronchoscopy Fever

Interventions: Drug: ibuprofen

First Posted Date: 2009-08-07

Last Posted Date: 2020-10-26

Lead Sponsor: Shaare Zedek Medical Center

Target Recruit Count: 64

Registration Number: NCT00954200

Locations: 🇮🇱
Shaare Zedek Medical Center POB 3235, Jerusalem, Israel
🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel

A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen

Not Applicable

Completed

Conditions: Dysmenorrhea

Interventions: Device: Vipon
Drug: Ibuprofen

First Posted Date: 2009-08-04

Last Posted Date: 2011-06-16

Lead Sponsor: Another Way Products

Target Recruit Count: 115

Registration Number: NCT00951561

Locations: 🇺🇸
University of Kansas Medical Center, Department of Obstetrics and Gynecology, Kansas City, Missouri, United States
🇺🇸
Truman Medical Center, Kansas City, Missouri, United States