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Diclofenac Sodium gel, 1%
Diclofenac sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of application.
Diclofenac sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of application. Used for Topical treatment of localized pain and inflammation in musculoskeletal conditions (e.g., osteoarthritis, rheumatoid arthritis, sprains, strains), Post-traumatic inflammation and pain relief.
At a glance
| Generic name | Diclofenac Sodium gel, 1% |
|---|---|
| Sponsor | Glenmark Pharmaceuticals Ltd. India |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) |
| 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 gel, it penetrates the skin to reach underlying tissues and joints, providing localized anti-inflammatory and analgesic effects with reduced systemic exposure compared to oral formulations.
Approved indications
- Topical treatment of localized pain and inflammation in musculoskeletal conditions (e.g., osteoarthritis, rheumatoid arthritis, sprains, strains)
- Post-traumatic inflammation and pain relief
Common side effects
- Local skin irritation or rash at application site
- Photosensitivity reactions
- Pruritus
- Erythema
Key clinical trials
- Counterpain PXM Versus Diclofenac Versus Piroxicam (PHASE3)
- 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)
- Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days. (PHASE1)
- To Check Dermatological Safety of Test Products by 24 Hours Patch Testing (NA)
- Topical Diclofenac for Hand-Foot Syndrome Prevention in Colorectal and Gastric Cancer on Capecitabine (DICLO-HFS)
- A Study of Diclofenac Gel in Women With Primary Dysmenorrhea (PHASE1)
- Exercise vs. Topical Diclofenac vs. PRP (NA)
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, 1% CI brief — competitive landscape report
- Diclofenac Sodium gel, 1% updates RSS · CI watch RSS
- Glenmark Pharmaceuticals Ltd. India portfolio CI