Pipeline

Topical Roflumilast Cream

(ARQ-151)

Clinical development

Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase-4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases the production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases, including psoriasis, atopic dermatitis, and chronic obstructive pulmonary disease (COPD).

PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the systemic treatment of plaque psoriasis. Topical roflumilast cream is a highly potent, selective PDE4 inhibitor in a convenient, once-daily formulation that Arcutis is studying in atopic dermatitis.

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Atopic Dermatitis

Arcutis is developing roflumilast cream 0.05% for the treatment of atopic dermatitis in children 2 to 5 years old.

We have completed a 652-patient Phase 3 study of roflumilast cream 0.05% in children with atopic dermatitis ages 2 to 5, which met its primary endpoint and all secondary endpoints. In this study, roflumilast cream demonstrated symptomatic improvement across endpoints and a favorable tolerability profile in this patient population. Based off of this positive data, the Company intends to submit a supplementary new drug application to the U.S. Food and Drug Administration.

Arcutis’ pipeline will change as molecules move through the drug development process. The safety and efficacy of the investigational agents or investigational uses of marketed products have not been established. These uses have not been approved by the US Food and Drug Administration or other regulatory authorities.

There is no guarantee that these therapies or uses will be commercialized. Some of the content on this page is not intended for users outside the US.