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Arcutis Biotherapeutics (ARQT) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
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%Atopic Dermatitis, ItchPhase IVRecruitingObtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.Apr 23, 2026
Arq-234Eczema, Atopic Dermatitis (Ad)Phase 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―
Arq-151 Cream 0.15% Or Arq-151 Cream 0.05%Atopic Dermatitis EczemaPhase IIICompletedOpen Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic DermatitisMar 16, 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 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.