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Diclofenac sodium gel 3%
Diclofenac sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of topical application.
Diclofenac sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of topical application. Used for Topical treatment of pain and inflammation associated with osteoarthritis and other musculoskeletal conditions, Acute pain and inflammation from minor injuries and sprains.
At a glance
| Generic name | Diclofenac sodium gel 3% |
|---|---|
| Also known as | Solaraze®, Diclofenac Sodium |
| Sponsor | LEO Pharma |
| Drug class | NSAID (nonsteroidal anti-inflammatory drug) |
| Target | COX-1 and COX-2 (cyclooxygenase enzymes) |
| Modality | Small molecule |
| Therapeutic area | Pain management / Rheumatology |
| Phase | FDA-approved |
Mechanism of action
As a nonsteroidal anti-inflammatory drug (NSAID), diclofenac blocks COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. When applied topically as a 3% gel, the drug penetrates local tissues to provide anti-inflammatory and analgesic effects with reduced systemic exposure compared to oral formulations.
Approved indications
- Topical treatment of pain and inflammation associated with osteoarthritis and other musculoskeletal conditions
- Acute pain and inflammation from minor injuries and sprains
Common side effects
- Local skin irritation or dermatitis at application site
- Photosensitivity reactions
- Rash or allergic contact dermatitis
Key clinical trials
- Counterpain PXM Versus Diclofenac Versus Piroxicam (PHASE3)
- Home-Based Strategies for Knee Osteoarthritis (NA)
- Effects of Photobiomodulation and Topical Diclofenac on Inflammation and Pain in Knee Osteoarthritis (EPIC-KO) (PHASE2)
- A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain (PHASE4)
- To Check Dermatological Safety of Test Products by 24 Hours Patch Testing (NA)
- A Study of Diclofenac Gel in Women With Primary Dysmenorrhea (PHASE1)
- Exercise vs. Topical Diclofenac vs. PRP (NA)
- Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children (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:
- Diclofenac sodium gel 3% CI brief — competitive landscape report
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