NDATOPICALCREAM
Approved
Jul 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
ZORYVE (roflumilast) by Arcutis Biotherapeutics is phosphodiesterase 4 inhibitors [moa]. Approved for chronic obstructive pulmonary disease. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 1w 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 chronic obstructive pulmonary disease (COPD). It works by inhibiting PDE-4 enzyme activity to reduce airway inflammation and improve lung function. This represents the first topical formulation of roflumilast, differentiating it from the oral predecessor DALIRESP.
Peak11.3 years to LOE
Product is at peak commercial maturity with established market presence; sales and marketing teams are focused on maximizing adoption and market share among pulmonologists and respiratory specialists.
Mechanism of Action
Phosphodiesterase 4 Inhibitors
Pharmacologic Class:
Phosphodiesterase 4 Inhibitor
Indications (1)
Clinical Trials (20)
Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.
Started Apr 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)
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)
Started Sep 2023
40 enrolled
Chronic Hand 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.