Last reviewed 2026-04-20 · How we verify

Daliresp (ROFLUMILAST)

Daliresp works by blocking an enzyme called phosphodiesterase 4, which helps reduce inflammation in the body.

At a glance

Mechanism of action

Roflumilast and its active metabolite (roflumilast N-oxide) are selective inhibitors of phosphodiesterase (PDE4). Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic-3,5-adenosinemonophosphate (cyclic AMP)-metabolizing enzyme in lung tissue) activity leads to accumulation of intracellular cyclic AMP. While the specific mechanism(s) bywhich Roflumilast Tablets exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells.

Approved indications

• COPD Associated with Chronic Bronchitis
• Plaque psoriasis
• Severe chronic obstructive pulmonary disease

Common side effects

• Diarrhea
• Headache
• Insomnia
• Nausea
• Application site pain
• Upper respiratory tract infection
• Urinary tract infection
• Application site urticaria

Drug interactions

• CYP3A4 inhibitors or dual inhibitors of CYP3A4 and CYP1A2 (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine)
• Strong cytochrome P450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin)
• Oral contraceptives containing gestodene and ethinyl estradiol

Key clinical trials

• The Role of Phosphodiesterase Inhibitors in Incretin Secretion (PHASE1)
• Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
• Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) (PHASE4)
• Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05) (PHASE2,PHASE3)
• Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07) (PHASE3)
• The Safety and Efficacy of Roflumilast Foam in HS (PHASE2)
• A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR) (PHASE3)
• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)

Patents

Primary sources

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