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AMZ001 Diclofenac gel
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Topical treatment of localized pain and inflammation associated with musculoskeletal conditions (e.g., osteoarthritis, sprains, strains).
At a glance
| Generic name | AMZ001 Diclofenac gel |
|---|---|
| Sponsor | Amzell |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | COX-1 and COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Diclofenac blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. By reducing local prostaglandin levels at the site of application, the topical gel formulation provides localized anti-inflammatory and analgesic effects with reduced systemic exposure compared to oral formulations.
Approved indications
- Topical treatment of localized pain and inflammation associated with musculoskeletal conditions (e.g., osteoarthritis, sprains, strains)
Common side effects
- Local skin irritation or rash at application site
- Pruritus
- Erythema
Key clinical trials
- A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (PHASE3)
- 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)
- Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants (PHASE1)
- AMZ001 for the Treatment of Knee Osteoarthritis Symptoms (PHASE2, 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:
- AMZ001 Diclofenac gel CI brief — competitive landscape report
- AMZ001 Diclofenac gel updates RSS · CI watch RSS
- Amzell portfolio CI