NDAORALTABLET
Approved
Feb 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
DALIRESP (roflumilast) by AstraZeneca is phosphodiesterase 4 inhibitors [moa]. First approved in 2011.
Drug data last refreshed 18h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DALIRESP (roflumilast) is an oral phosphodiesterase 4 (PDE-4) inhibitor approved in 2011 for chronic obstructive pulmonary disease (COPD). It reduces airway inflammation by inhibiting PDE-4 enzyme activity, thereby increasing intracellular cAMP levels in immune and structural lung cells. The drug is indicated as maintenance therapy to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
$0.029BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending ($29M, 52.9K claims in 2023), indicating a niche market with limited team expansion opportunities.
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.