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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 0.3%; ZORYVE

Latest Information Update: 14 Mar 2024

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At a glance

  • Originator Arcutis Inc
  • Developer Arcutis Biotherapeutics
  • 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 Plaque psoriasis; Seborrhoeic dermatitis
  • Preregistration Atopic dermatitis

Most Recent Events

  • 10 Mar 2024 Efficacy data from a phase III INTEGUMENT-PED trial in Atopic dermatitis released by Arcutis Biotherapeutics
  • 05 Mar 2024 FDA assigns PDUFA action date of 07/07/2024 for Roflumilast 0.15% cream for Atopic dermatitis (In children (6 years and above), In adults)
  • 01 Mar 2024 Roflumilast topical licensed to Sato in Japan
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