Mufemilast - Hemay Pharmaceutical

Mufemilast Tablet

Mechanism of Action Introduction:

PDE4 specifically hydrolyzes cAMP and is the primary PDE in immune cells. Since many inflammatory and immune responses in the body are regulated by PDE4, selective PDE4 inhibitors can increase intracellular cAMP levels and exert broad anti-inflammatory effects. Mufemilast reduces the hydrolysis of cAMP by blocking the overexpression of the PDE4B protein and inhibiting PDE4 activity, thereby increasing intracellular cAMP levels. This effectively suppresses the proliferation of key cells (such as Th1, Th2, Th17) involved in the pathogenesis of autoimmune diseases and the production of inflammatory factors, resulting in fewer side effects and high safety.

1Trial Title:A multicenter, randomized, double-blind, placebo-controlled Phase III clinical study on the efficacy and safety of Mufemilast tablets in patients with Behçet's disease (BD).

: Target Population：
Patients with Behcet's Disease (BD)

: Clinical Project Description：
A multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of Mufemilast tablets in treating patients with Behçet's disease (BD).

* For main inclusion and exclusion criteria, please visit the China Drug Clinical Trial Registration and Information Disclosure Platform

2Trial Title:A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study on the efficacy and safety of Mufemilast tablets in the treatment of moderate-to-severe atopic dermatitis (AD).

: Target Population：
Patients with moderate-to-severe atopic dermatitis (AD)

: Clinical Project Description：
A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of Mufemilast tablets in treating moderate-to-severe atopic dermatitis (AD), and to observe the in vivo exposure of Mufemilast tablets in AD patients.

* For main inclusion and exclusion criteria, please visit the China Drug Clinical Trial Registration and Information Disclosure Platform

3Trial Title:A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study on the efficacy and safety of Mufemilast tablets in the treatment of active ankylosing spondylitis (AS).

: Target Population：
Patients with moderate-to-severe active ankylosing spondylitis (AS)

: Clinical Project Description：
A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of Mufemilast tablets in treating active ankylosing spondylitis, as well as its population pharmacokinetic characteristics.

* For main inclusion and exclusion criteria, please visit the China Drug Clinical Trial Registration and Information Disclosure Platform

4Trial Title:A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial on the efficacy and safety of Mufemilast in patients with moderate-to-severe ulcerative colitis (UC).

: Target Population：
Patients with moderate-to-severe ulcerative colitis (UC)

: Clinical Project Description：
A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of Mufemilast tablets in treating moderate-to-severe ulcerative colitis, as well as its population pharmacokinetic characteristics.

* For main inclusion and exclusion criteria, please visit the China Drug Clinical Trial Registration and Information Disclosure Platform

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