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Diclofenac hydroxyethylpyrrolidine
Diclofenac hydroxyethylpyrrolidine is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and inflammation.
Diclofenac hydroxyethylpyrrolidine is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and inflammation. Used for Acute pain and inflammation, Rheumatoid arthritis, Osteoarthritis.
At a glance
| Generic name | Diclofenac hydroxyethylpyrrolidine |
|---|---|
| Also known as | Flector Patch, Voltaren, Abitren |
| Sponsor | IBSA Institut Biochimique SA |
| Drug class | Non-steroidal anti-inflammatory drug (NSAID) |
| Target | Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) |
| Modality | Small molecule |
| Therapeutic area | Pain management, Rheumatology, Inflammation |
| Phase | FDA-approved |
Mechanism of action
This drug blocks COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. By reducing prostaglandin levels, it provides analgesic, anti-inflammatory, and antipyretic effects. The hydroxyethylpyrrolidine salt formulation is designed to improve solubility and bioavailability compared to standard diclofenac.
Approved indications
- Acute pain and inflammation
- Rheumatoid arthritis
- Osteoarthritis
- Musculoskeletal disorders
Common side effects
- Gastrointestinal upset (nausea, dyspepsia)
- Abdominal pain
- Headache
- Dizziness
- Increased risk of cardiovascular events
- Increased risk of gastrointestinal bleeding
Key clinical trials
- Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants with Minor Soft Tissue Injury (PHASE3)
- Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs (PHASE3)
- Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning (NA)
- Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day (PHASE1)
- Evaluation of Bioavailability of Diclofenac Dermal Products (EARLY_PHASE1)
- Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain (PHASE3)
- Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients (NA)
- Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine (EARLY_PHASE1)
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:
- Diclofenac hydroxyethylpyrrolidine CI brief — competitive landscape report
- Diclofenac hydroxyethylpyrrolidine updates RSS · CI watch RSS
- IBSA Institut Biochimique SA portfolio CI