|Systematic (IUPAC) name|
|Trade names||Daxas, Daliresp|
|Licence data||EMA:, US FDA:|
|Pregnancy cat.||B3 (AU) C (US)|
|Legal status||Prescription Only (S4) (AU) ℞-only (CA) POM (UK) ℞-only (US)|
|Metabolism||Hepatic via CYP1A2 & CYP3A4|
|Half-life||17 hours (30 hours [active metabolite])|
|Mol. mass||403.207 g/mol|
|(what is this?)|
Roflumilast (trade names Daxas, Daliresp) is a drug which acts as a selective, long-acting inhibitor of the enzyme PDE-4. It has anti-inflammatory effects and is under development as an orally administered drug for the treatment of inflammatory conditions of the lungs such as asthma, and chronic obstructive pulmonary disease (COPD).
In June 2010, Daxas was approved in the EU for severe COPD associated with chronic bronchitis. In March 2011, Daliresp gained FDA approval in the US for reducing COPD exacerbations.