Last reviewed · How we verify
Diclofenac diethylamine
Diclofenac diethylamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.
Diclofenac diethylamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Acute pain and inflammation, Musculoskeletal pain and inflammation, Postoperative pain.
At a glance
| Generic name | Diclofenac diethylamine |
|---|---|
| Sponsor | Taisho Pharmaceutical Co., Ltd. |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | Cyclooxygenase-1 (COX-1), Cyclooxygenase-2 (COX-2) |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Rheumatology, Inflammation |
| Phase | Phase 3 |
Mechanism of action
Diclofenac diethylamine is a salt formulation of diclofenac designed for topical or systemic delivery. It works by inhibiting both COX-1 and COX-2 enzymes, which catalyze prostaglandin production. By reducing prostaglandins, the drug decreases inflammatory mediators and provides analgesic and anti-inflammatory effects. The diethylamine salt form may enhance absorption and bioavailability compared to the base diclofenac.
Approved indications
- Acute pain and inflammation
- Musculoskeletal pain and inflammation
- Postoperative pain
Common side effects
- Gastrointestinal upset (nausea, dyspepsia)
- Headache
- Dizziness
- Rash or skin irritation (topical formulations)
- Increased cardiovascular risk (with chronic use)
Key clinical trials
- 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 vs.Oral Ibuprofen for MSK Pain in Children (PHASE3)
- Clinical Study on the Combination of Xiaoyu Zhitong Formula and Lymphatic Drainage Technique to Improve the Symptoms of Knee Pain and Swelling in Cold Dampness Obstruction Type
- A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs. (PHASE2)
- Topical Treatments for Ankle Sprains
- Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study (PHASE3)
- Safety and Efficacy of SFPP in Knee Osteoarthritis (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 diethylamine CI brief — competitive landscape report
- Diclofenac diethylamine updates RSS · CI watch RSS
- Taisho Pharmaceutical Co., Ltd. portfolio CI