NDATOPICALCREAM
Approved
Jul 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
ZORYVE (roflumilast) by Arcutis Biotherapeutics is phosphodiesterase 4 inhibitors [moa]. First approved in 2022.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZORYVE (roflumilast) is a topical phosphodiesterase 4 (PDE-4) inhibitor cream approved in July 2022 for inflammatory skin conditions. It works by inhibiting PDE-4, reducing production of pro-inflammatory mediators in dermal and epidermal cells. The drug represents Arcutis Biotherapeutics' first FDA-approved product and addresses unmet needs in localized dermatologic inflammation.
Peak10.8 years to LOE
Product is in peak commercial phase with minimal direct competition, creating opportunity for market expansion and team building.
Mechanism of Action
Phosphodiesterase 4 Inhibitors
Pharmacologic Class:
Phosphodiesterase 4 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis
Started Aug 2026
309 enrolled
Seborrheic Dermatitis
Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.
Started Jul 2026
40 enrolled
ITCHAtopic Dermatitis
A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa
Started Sep 2025
10 enrolled
Hidradenitis Suppurativa
An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)
Started Aug 2025
20 enrolled
Non-segmental Vitiligo
Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis
Started Jun 2025
101 enrolled
Atopic Dermatitis (Eczema)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.