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Diclofenac diethylamine 1.16% gel
Diclofenac diethylamine 1.16% gel is a NSAID (nonsteroidal anti-inflammatory drug) Small molecule drug developed by Novartis. It is currently FDA-approved for Topical treatment of pain and inflammation associated with osteoarthritis and other joint conditions, Localized musculoskeletal pain and inflammation.
Diclofenac inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of application.
Diclofenac inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of application. Used for Topical treatment of pain and inflammation associated with osteoarthritis and other joint conditions, Localized musculoskeletal pain and inflammation.
At a glance
| Generic name | Diclofenac diethylamine 1.16% gel |
|---|---|
| Sponsor | Novartis |
| Drug class | NSAID (nonsteroidal anti-inflammatory drug) |
| Target | COX-1, COX-2 |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Rheumatology |
| Phase | FDA-approved |
Mechanism of action
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by blocking 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 pain and inflammation associated with osteoarthritis and other joint conditions
- Localized musculoskeletal pain and inflammation
Common side effects
- Local skin irritation or rash at application site
- Pruritus
- Erythema
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)
- Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study (PHASE3)
- Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain (PHASE4)
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 1.16% gel CI brief — competitive landscape report
- Diclofenac diethylamine 1.16% gel updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Diclofenac diethylamine 1.16% gel
What is Diclofenac diethylamine 1.16% gel?
How does Diclofenac diethylamine 1.16% gel work?
What is Diclofenac diethylamine 1.16% gel used for?
Who makes Diclofenac diethylamine 1.16% gel?
What drug class is Diclofenac diethylamine 1.16% gel in?
What development phase is Diclofenac diethylamine 1.16% gel in?
What are the side effects of Diclofenac diethylamine 1.16% gel?
What does Diclofenac diethylamine 1.16% gel target?
Related
- Drug class: All NSAID (nonsteroidal anti-inflammatory drug) drugs
- Target: All drugs targeting COX-1, COX-2
- Manufacturer: Novartis — full pipeline
- Therapeutic area: All drugs in Pain Management, Rheumatology
- Indication: Drugs for Topical treatment of pain and inflammation associated with osteoarthritis and other joint conditions
- Indication: Drugs for Localized musculoskeletal pain and inflammation
- Compare: Diclofenac diethylamine 1.16% gel vs similar drugs
- Pricing: Diclofenac diethylamine 1.16% gel cost, discount & access