NDAORALTABLET
Approved
Feb 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
DALIRESP (roflumilast) by AstraZeneca is phosphodiesterase 4 inhibitors [moa]. Approved for chronic obstructive pulmonary disease. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DALIRESP (roflumilast) is an oral phosphodiesterase-4 (PDE-4) inhibitor tablet approved by the FDA in February 2011 for the treatment of chronic obstructive pulmonary disease (COPD). It works by inhibiting PDE-4 enzyme activity, reducing inflammation in the airways and lungs. As a once-daily oral therapy, DALIRESP offers an alternative to inhaled maintenance treatments, though it is typically used as an add-on therapy in moderate-to-severe COPD patients not adequately controlled on other agents.
$0.0BPart D
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.