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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: 19 Dec 2024

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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

Most Recent Events

  • 16 Dec 2024 Arcutis Biotherapeutics submits sNDA to the US FDA for roflumilast cream 0.05% for Atopic dermatitis (In children) in USA
  • 28 Nov 2024 Phase-III clinical trials in Atopic dermatitis (In children, In adolescents, In adults, In the elderly) in China (Topical) (NCT06631170)
  • 14 Nov 2024 Phase-III clinical trials in Plaque psoriasis (In adults, In children, In the elderly) in China (Topical) (NCT06648772)

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