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Arcutis Biotherapeutics (ARQT) Drug Pipeline

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Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Vehicle Cream, Roflumilast Cream 0.3%Atopic Dermatitis, Atopic Dermatitis (Ad), Atopic Dermatitis (Eczema)Phase IIIRecruitingRoflumilast Cream 0.3% for Moderate to Severe Atopic DermatitisOct 30, 2026―
Vehicle Foam, Roflumilast Foam 0.3%Seborrheic DermatitisPhase IIINot Yet RecruitingEfficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic DermatitisJun 22, 2026
Roflumilast Cream 0.15%Itch, Atopic DermatitisPhase IVRecruitingObtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.Apr 23, 2026
Arq-234Atopic Dermatitis (Ad), EczemaPhase IRecruitingPh 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234Mar 02, 2026
Arq-154 Foam 0.3%PsoriasisPhase ICompletedMaximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body PsoriasisDec 19, 2025―
Arq-151 Cream 0.05%Atopic Dermatitis (Eczema)Phase IIRecruitingSafety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic DermatitisMay 05, 2025―
Vehicle Foam, Roflumilast Foam 0.3%Scalp PsoriasisPhase IIICompletedTopical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)Aug 25, 2021―
Vehicle Foam, Roflumilast FoamSeborrheic DermatitisPhase IIICompletedTrial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)Jul 13, 2021―
Arq-151 Active, Arq-151 VehicleAtopic Dermatitis EczemaPhase IIICompletedTrial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)Apr 11, 2021―
Arq-252 Cream 0.3%, Arq-252 Vehicle Cream, Nb-Uvb Phototherapy Active Treatment, Nb-Uvb Phototherapy Sham TreatmentVitiligoPhase IITerminatedSafety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial VitiligoMar 18, 2021―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Arcutis Biotherapeutics Inc (ARQT) have in its pipeline
Arcutis Biotherapeutics ARQT is currently developing the following drugs: Vehicle Cream, Roflumilast Cream 0.3%, Vehicle Foam, Roflumilast Foam 0.3%, Roflumilast Cream 0.15%, Arq-234, Arq-154 Foam 0.3%, Arq-151 Cream 0.05%, Vehicle Foam, Roflumilast Foam, Arq-151 Active, Arq-151 Vehicle, Arq-252 Cream 0.3%, Arq-252 Vehicle Cream, Nb-Uvb Phototherapy Active Treatment, Nb-Uvb Phototherapy Sham Treatment, Arq-151 Cream 0.15% Or Arq-151 Cream 0.05%, Vehicle Cream, Roflumilast Cream 0.15%, Roflumilast Cream, Vehicle Cream, Arq-151 Cream 0.3%, Arq-154, Arq-252 Cream 0.3%, Arq-252 Cream 0.1%, Arq-252 Vehicle Cream, Topical Roflumilast, Arq-151- Cream 0.3%, Arq-151 Vehicle Cream, Arq-151 0.3% Cream, Vehicle Cream, Roflumilast 0.3% Cream, Arq-151 Cream 0.15%, Arq-151 Cream 0.05%, Vehicle Cream, Roflumilast Cream 0.15%, Roflumilast Cream 0.05%, Roflumilast, Vehicle Cream, Roflumilast Cream 0.3%, Roflumilast Cream 0.15%, Arq-151 Cream 0.5%, Arq-151 Cream 0.15%, Arq-151 Vehicle Cream. These drug candidates are in various stages of clinical development as the company works toward FDA approval.