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Arcutis Biotherapeutics, Inc.

Pipeline3 assets

  • Topical Roflumilast CreamARQ-151 / ZORYVE / PDE4 / small molecule topical cream / Dermatology
    Plaque psoriasis 0.3% (2-5 yr)sNDA submittedPDUFA June 29, 2026USAtopic dermatitis 0.05% (3-24 mo)Phase 2planned sNDA submission Q2 2026US
  • Topical Roflumilast FoamARQ-154 / ZORYVE / PDE4 / small molecule topical foam / Dermatology
    Vitiligo 0.3%Phase 2acurrently enrolling; advancement decision Q4 2026Hidradenitis suppurativa 0.3%Phase 2acurrently enrolling; advancement decision Q1 2027
  • ARQ-234ARQ-234 / CD200R / fusion protein biologic / Dermatology
    Atopic dermatitisPhase 1a/1benrolling

Latest news13 items

All news

Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting

Investigational ZORYVE® (roflumilast) cream 0.05% was well tolerated with safety findings consistent with prior pediatric experience in the INTEGUMENT program ZORYVE cream improved signs and symptoms of mild to moderate atopic dermatitis in infants aged 3 months to less than 24 months over four

Presentation / Abstract • Phase 2

Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data with ZORYVE® (roflumilast) Cream 0.05% for Treatment of Mild-to-Moderate Atopic Dermatitis in Children Ages 2–5 in Pediatric Dermatology

ZORYVE cream 0.05% was safe and well-tolerated, with efficacy that was maintained and improved over time up to 56 weeks of treatment Children ages 2-5 who achieved disease clearance and who switched to proactive twice-weekly application sustained disease control for a median duration of ~8 months

Arcutis Biotherapeutics, Inc. • Endpoint Arena