MedPath

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
C13H18O2
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
Clinical Trials
Related News

Haleon Partners with Brightseed to Leverage AI for Natural Bioactive Discovery in Consumer Health

• Haleon and Brightseed have formed a strategic collaboration to utilize Brightseed's Forager® AI platform for discovering plant-based small molecules with potential health benefits. • The partnership will give Haleon's scientists direct access to the Forager platform, integrating AI-powered discovery into their research and product development pipelines. • Brightseed's technology has already identified plant compounds with applications in metabolic health, gut health, and immunity, aligning with Haleon's commitment to science-backed consumer health innovation.

Cumberland Pharmaceuticals Reports Breakthrough in DMD Treatment and 11.6% Q4 Revenue Growth

• Cumberland Pharmaceuticals achieved positive Phase II results for ifetroban in treating cardiac complications of Duchenne muscular dystrophy, marking the first successful study of its kind. • The company's Q4 2024 revenue reached $10.4 million, representing an 11.6% year-over-year increase, while securing FDA Orphan Drug and Rare Pediatric Disease designations for ifetroban. • Cumberland's antibiotic Vibativ received approval in China, expanding its international presence, while the FDA approved a simplified dosing regimen for Acetadote.

Qureight's AI Imaging Platform to Support Avalyn's Inhaled Pirfenidone Trial in Pulmonary Fibrosis

• Qureight and Avalyn Pharma have formed a strategic partnership to integrate deep-learning imaging technology in the Phase 2b MIST trial evaluating inhaled pirfenidone (AP01) for progressive pulmonary fibrosis. • The collaboration marks the first-ever use of deep-learning imaging technologies in a progressive pulmonary fibrosis clinical study, aiming to enhance treatment response measurement. • Avalyn's inhaled pirfenidone formulation targets improved efficacy and reduced side effects compared to current oral antifibrotic therapies by delivering medication directly to affected lung tissue.

OKYO Pharma Advances Phase 2a Trial for First-Ever Neuropathic Corneal Pain Treatment

• OKYO Pharma expects to complete enrollment of 48 patients in its Phase 2a trial of OK-101, the first FDA-cleared investigational drug specifically for neuropathic corneal pain, by Q2 2025. • The company recently reported positive Phase 2b results for OK-101 in dry eye disease, showing significant improvements in conjunctival staining and symptom reduction with a favorable safety profile. • The Phase 2a NCP trial, led by renowned expert Dr. Pedram Hamrah at Tufts Medical Center, is designed as a double-masked, randomized, 12-week placebo-controlled study.

Aspirin Reduces Colorectal Cancer Recurrence in PI3K-Mutated Tumors

• A daily 160mg dose of aspirin significantly reduces the risk of colorectal cancer recurrence in patients with PI3K mutations. • The ALASCCA trial demonstrated a 51% to 58% reduction in recurrence risk in patients with specific PI3K pathway alterations. • The study highlights the potential for repurposing aspirin as a cost-effective adjuvant therapy and emphasizes the importance of genomic testing. • While aspirin was generally safe, the study reported a slightly higher incidence of adverse events compared to placebo.

FDA Approves Journavx, a Novel Non-Opioid Painkiller, Offering New Hope for Acute Pain Management

• The FDA has approved Journavx (suzetrigine), a first-in-class non-opioid analgesic, for treating moderate to severe acute pain in adults, offering a safer alternative to opioids. • Journavx works by selectively blocking pain signals in the peripheral nervous system, reducing pain without the addictive potential and severe side effects associated with opioids. • Clinical trials demonstrated Journavx's effectiveness in reducing pain after surgeries, with a safety profile comparable to placebo, though it didn't outperform opioid-acetaminophen combinations. • Priced at $15.50 per pill, Journavx faces challenges in accessibility due to its higher cost compared to generic opioids, but it represents a significant step in combating the opioid crisis.

FDA Approves Simplified Dosing Regimen for Acetadote in Acetaminophen Overdose

• The FDA has approved a supplemental New Drug Application (sNDA) for Acetadote, used to prevent liver damage following acetaminophen overdose. • The new dosing regimen simplifies Acetadote administration by combining the first two doses into a single, slower infusion, reducing medication errors. • This streamlined approach, already implemented internationally, improves efficiency and patient outcomes without compromising effectiveness. • Acetaminophen overdose is a leading cause of acute liver failure in the U.S., making this approval a significant advancement.

Leqembi's EU Approval Faces Further Delay as EMA Re-evaluates Safety Data

• The European Commission has requested the EMA to re-examine Leqembi's safety data, potentially delaying its EU approval beyond the expected timeframe. • The CHMP will assess recent safety data to determine if an update to its positive opinion is needed, particularly regarding risk minimization measures. • Eisai and Biogen believe existing data support Leqembi's safety profile, reinforced by clinical use in the US and other approved regions. • Leqembi is already approved in the US, Japan, China and other countries, with a new once-monthly intravenous maintenance dose approved in the US.

Cumberland Pharma Reports Key Clinical and Business Developments in November 2024

Cumberland Pharma has announced significant milestones in November 2024, including new research findings, expanded Medicaid coverage, and product access improvements. Highlights include favorable outcomes for Caldolor® compared to ketorolac, FDA designations for Ifetroban targeting Duchenne Muscular Dystrophy, advancements in delirium treatment, and efforts to combat antimicrobial resistance with Vibativ®.

FDA Proposes Ban on Oral Phenylephrine in OTC Decongestants

• The FDA has proposed removing oral phenylephrine from over-the-counter decongestants after determining it is no more effective than a placebo. • This decision follows unanimous agreement from an FDA advisory body and years of scientific debate regarding phenylephrine's efficacy. • The ban, if finalized, will impact numerous popular products like Sudafed PE, Tylenol Cold & Flu Severe, and Vicks DayQuil, reshaping the OTC decongestant market. • The proposed order does not affect nasal sprays or eye drops containing phenylephrine, which are considered more effective delivery methods.

Ifetroban Shows Promise in Improving Heart Function for DMD Patients in Phase 2 Trial

• Ifetroban, an oral thromboxane receptor antagonist, significantly improved left ventricular ejection fraction (LVEF) in Duchenne muscular dystrophy (DMD) patients. • The FIGHT DMD trial demonstrated a 3.3% improvement in LVEF with high-dose ifetroban, contrasting with a decline in the placebo group. • Compared to natural history controls, high-dose ifetroban showed a 5.4% overall LVEF improvement, suggesting a potential disease-modifying effect. • Ifetroban has received Orphan Drug and Rare Pediatric Disease designations, potentially becoming the first targeted therapy for DMD-related heart disease.
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy