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Comparator: ibuprofen
Ibuprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.
Ibuprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever. Used for Mild to moderate pain, Fever reduction, Inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis).
At a glance
| Generic name | Comparator: ibuprofen |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | COX-1, COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Inflammation, Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that non-selectively blocks COX-1 and COX-2 enzymes, which catalyze prostaglandin production. By reducing prostaglandins, it suppresses inflammatory responses and pain signaling. This mechanism also accounts for its antipyretic effects and potential gastrointestinal and cardiovascular side effects.
Approved indications
- Mild to moderate pain
- Fever reduction
- Inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis)
Common side effects
- Gastrointestinal upset (nausea, dyspepsia, abdominal pain)
- Headache
- Dizziness
- Rash
- Increased cardiovascular risk (with chronic use)
- Renal impairment (with chronic use)
Key clinical trials
- Opioid-Free Pain Protocol After Shoulder Arthroplasty (PHASE4)
- Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients (NA)
- Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus (PHASE1)
- A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED) (PHASE3)
- An Investigational Drug in Patients With Osteoarthritis (0663-073) (PHASE3)
- An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision (PHASE2)
- A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants (PHASE1)
- PAIR (Paracetamol and Ibuprofen Research) Pilot Trial (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comparator: ibuprofen CI brief — competitive landscape report
- Comparator: ibuprofen updates RSS · CI watch RSS
- Organon and Co portfolio CI