Drug intelligence / Profile preview

diclofenac (AMZ001 formulation)

Development stage
Phase 3
Lead developer
Amzell
Modality
Small Molecules
Administration
Topical
01

Overview

AMZ001 is a novel topical gel formulation containing 3.06% diclofenac sodium, developed specifically for the treatment of knee osteoarthritis pain. It is designed to provide effective localized pain relief with a single daily application, reducing systemic exposure and minimizing adverse effects commonly associated with oral NSAIDs. Clinical trials have demonstrated that AMZ001 offers statistically significant reductions in knee osteoarthritis pain compared to placebo, with a favorable safety and tolerability profile. The most common side effects are mild application site reactions such as dryness or erythema, and no serious adverse events have been reported. Developed by Amzell BV, this high-strength topical NSAID aims to improve onset and duration of pain relief while enhancing patient convenience through reduced frequency of application[2][3][5].

Other names
AMZ001AMZ-001AMZ 001
02

Targets

PGHS-1 (Prostaglandin G/H Synthase 1)

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