Last reviewed · How we verify
Diclofenac Sodium Topical Gel, 1%
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 relief of pain and inflammation associated with osteoarthritis and other musculoskeletal conditions.
At a glance
| Generic name | Diclofenac Sodium Topical Gel, 1% |
|---|---|
| Sponsor | Amneal Pharmaceuticals, LLC |
| 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, the drug penetrates local tissues to provide anti-inflammatory and analgesic effects with reduced systemic exposure compared to oral formulations.
Approved indications
- Topical relief of pain and inflammation associated with osteoarthritis and other musculoskeletal conditions
Common side effects
- Application site reactions (erythema, pruritus, irritation)
- Headache
- Gastrointestinal effects (if systemically absorbed)
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)
- 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)
- Exercise vs. Topical Diclofenac vs. PRP (NA)
- Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (PHASE2)
- Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain (PHASE1, PHASE2)
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 Topical Gel, 1% CI brief — competitive landscape report
- Diclofenac Sodium Topical Gel, 1% updates RSS · CI watch RSS
- Amneal Pharmaceuticals, LLC portfolio CI