Roflumilast
Medication
From Wikipedia, the free encyclopedia
Roflumilast, sold under the brand name Daxas among others, is a medication used for the treatment of chronic obstructive pulmonary disease,[4] plaque psoriasis,[5] seborrheic dermatitis,[6] and atopic dermatitis.[5] It acts as a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE-4).[10] It has anti-inflammatory effects.[10][11][12]
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| Trade names | Daxas, Daliresp, Zoryve, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a611034 |
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| Routes of administration | By mouth, topical |
| Drug class | PDE4 inhibitor |
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| Bioavailability | 79%[4][3][8][9] |
| Protein binding | 99%[4][3][8][9] |
| Metabolism | Hepatic via CYP1A2 & CYP3A4[4][3][8][9] |
| Elimination half-life | 17 hours (30 hours [active metabolite])[4][3][8][9] |
| Excretion | Urine (70%)[4][3][8][9] |
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| ECHA InfoCard | 100.210.960 |
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| Formula | C17H14Cl2F2N2O3 |
| Molar mass | 403.21 g·mol−1 |
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It was approved for medical use in the European Union in 2010,[7] in the United States in 2011,[4] and in Canada in 2017.[1] It is available as a generic medication.[13]
Medical uses
Roflumilast is indicated for the treatment of severe chronic obstructive pulmonary disease (COPD),[4] plaque psoriasis,[5][14] seborrheic dermatitis,[6] and atopic dermatitis,[5][15]
It is used in the prevention of exacerbations (lung attacks) in severe chronic obstructive pulmonary disease (COPD).[3][4][7][8][9]
Adverse effects
Society and culture
Legal status
In June 2010, an oral formulation of roflumilast was approved in the European Union for severe COPD associated with chronic bronchitis.[7][17] In February 2011, it gained FDA approval in the United States for reducing COPD exacerbations.[18][19]
In July 2022, the FDA approved roflumilast cream 0.3% (Zoryve) for the treatment of plaque psoriasis in patients 12 years of age and older.[20] In December 2023, the agency approved a 0.3% topical foam formulation for seborrheic dermatitis in patients aged nine and older, marking the first new mechanism of action for the condition in over two decades.[21] In July 2024, the FDA approved a 0.15% cream formulation as a once-daily treatment for mild to moderate atopic dermatitis in adults and children aged six and older.[22] In May 2025, the 0.3% foam formulation received further approval for plaque psoriasis in adults and adolescents aged 12 and older.[22][23][24] Subsequently, in October 2025, the FDA extended approval of a 0.05% cream formulation to include pediatric patients aged two to five with atopic dermatitis.[25]
