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Roflumilast topical - Arcutis Biotherapeutics

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Drug Profile

Roflumilast topical - Arcutis Biotherapeutics

Alternative Names: ARQ-151; ARQ-151 cream 0.3%; ARQ-154; ARQ-154 Foam; Roflumilast Cream 0.15%; Roflumilast cream 0.15% - Arcutis Biotherapeutics; roflumilast cream 0.3%; ZORYVE

Latest Information Update: 20 Mar 2026

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At a glance

  • Originator Arcutis Inc
  • Developer Arcutis Biotherapeutics; Hangzhou Zhongmei Huadong Pharmaceutical
  • Class Aminopyridines; Anti-inflammatories; Antiallergics; Antiasthmatics; Antipsoriatics; Benzamides; Chlorinated hydrocarbons; Cyclopropanes; Fluorinated hydrocarbons; Skin disorder therapies; Small molecules
  • Mechanism of Action Type 4 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Atopic dermatitis; Plaque psoriasis; Seborrhoeic dermatitis
  • Phase II Hidradenitis suppurativa; Vitiligo

Most Recent Events

  • 10 Mar 2026 Efficacy and adverse event data from the phase III INTEGUMENT-OLE trial in Atopic dermatitis released by Arcutis Biotherapeutics
  • 26 Feb 2026 Arcutis Biotherapeutics plans to submit sNDA to the US FDA for roflumilast cream 0.05% for Atopic dermatitis (In infants) in USA in the second half of 2026
  • 02 Feb 2026 Efficacy and adverse event data from a phase II trial in Atopic dermatitis released by Arcutis Biotherapeutics

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