Arcutis Biotherapeutics, Inc.
Arcutis Biotherapeutics is a pioneering medical dermatology company committed to meaningful innovation in the treatment of immune-mediated skin diseases. With a robust pipeline and a focus on addressing unmet medical needs, Arcutis aims to improve patient outcomes through differentiated therapies and clinical programs targeting conditions such as psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. The company leverages its unique dermatology development platform and expertise to develop and commercialize innovative treatments, including the FDA-approved ZORYVE (roflumilast) cream and foam, which are designed to provide safe and effective alternatives to steroids. Arcutis continues to expand its portfolio with new indications, clinical trials, and strategic collaborations, aiming to lead the future of dermatological therapeutics.
Industries
Nr. of Employees
large (251-1000)
Arcutis Biotherapeutics, Inc.
Patents
Topical roflumilast formulation having improved delivery and plasma half-life
US-12310956-B2
View Details
Topical roflumilast formulation having improved delivery and plasma half-life
US-12310956-B2
View DetailsProducts
Topical PDE4 inhibitor cream (once-daily; multiple concentrations)
Once-daily topical phosphodiesterase-4 (PDE4) inhibitor formulated as a cream for inflammatory skin conditions; developed and commercialized with multiple dosage strengths and pediatric supplement submissions.
Topical PDE4 inhibitor foam (once-daily formulation for hair-bearing areas)
Once-daily topical PDE4 inhibitor in a foam vehicle optimized for delivery in hair-bearing areas (scalp and body).
Topical JAK1 inhibitor formulations (suspension and cream)
Topical formulations of a selective JAK1 inhibitor developed as suspension and cream vehicles, including designs to target deeper follicular delivery for alopecia areata and other inflammatory dermatoses.
Checkpoint-agonist fusion protein biologic (preclinical)
Preclinical fusion protein designed to agonize the CD200 receptor as an immunomodulatory biologic candidate for atopic dermatitis and related autoimmune indications.
Topical PDE4 inhibitor cream (once-daily; multiple concentrations)
Once-daily topical phosphodiesterase-4 (PDE4) inhibitor formulated as a cream for inflammatory skin conditions; developed and commercialized with multiple dosage strengths and pediatric supplement submissions.
Topical PDE4 inhibitor foam (once-daily formulation for hair-bearing areas)
Once-daily topical PDE4 inhibitor in a foam vehicle optimized for delivery in hair-bearing areas (scalp and body).
Topical JAK1 inhibitor formulations (suspension and cream)
Topical formulations of a selective JAK1 inhibitor developed as suspension and cream vehicles, including designs to target deeper follicular delivery for alopecia areata and other inflammatory dermatoses.
Checkpoint-agonist fusion protein biologic (preclinical)
Preclinical fusion protein designed to agonize the CD200 receptor as an immunomodulatory biologic candidate for atopic dermatitis and related autoimmune indications.
Services
Clinical development services covering trial design, enrollment operations, biometrics and execution of pivotal Phase 3 and pediatric studies across dermatology indications.
Support for preparation and management of regulatory filings (IND/NDA/sNDA) including pediatric supplements and interactions with regulatory agencies.
Commercialization support including formulary engagement, payer contracting, gross-to-net management and deployment of specialty sales teams for dermatology products.
Structuring and managing regional licensing and collaboration agreements for development, manufacturing and commercialization with third-party partners.
Execution of acquisitions for preclinical programs and integration of external discovery and development activities into existing pipelines.
Clinical development services covering trial design, enrollment operations, biometrics and execution of pivotal Phase 3 and pediatric studies across dermatology indications.
Support for preparation and management of regulatory filings (IND/NDA/sNDA) including pediatric supplements and interactions with regulatory agencies.
Commercialization support including formulary engagement, payer contracting, gross-to-net management and deployment of specialty sales teams for dermatology products.
Structuring and managing regional licensing and collaboration agreements for development, manufacturing and commercialization with third-party partners.
Execution of acquisitions for preclinical programs and integration of external discovery and development activities into existing pipelines.
Expertise Areas
- Topical dermatology drug development
- Clinical trial management and biometrics for dermatology indications
- Formulation science and CMC for topical creams and foams
- Targeted follicular and deep-skin delivery
Key Technologies
- Topical cream and foam formulation
- Targeted follicular delivery technologies
- Topical JAK1 inhibitor formulations
- PDE4 inhibitor topical pharmacology
News & Updates
FDA approved ZORYVE foam for seborrheic dermatitis in December 2023.
Reported strong financial results with cash position supporting operations into 2024.
Acquired Ducentis to develop novel therapies for autoimmune diseases.
Company reports financial results and business update for Q1 2022.
Partnership to develop and commercialize topical roflumilast in Japan.
Received FDA approval for ZORYVE cream for plaque psoriasis in adults and children 6 years and older.
FDA approved ZORYVE foam for seborrheic dermatitis in December 2023.
Reported strong financial results with cash position supporting operations into 2024.
Acquired Ducentis to develop novel therapies for autoimmune diseases.
Company reports financial results and business update for Q1 2022.
Partnership to develop and commercialize topical roflumilast in Japan.
Received FDA approval for ZORYVE cream for plaque psoriasis in adults and children 6 years and older.