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Oral roflumilast
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammation by increasing intracellular cAMP levels in immune and structural cells.
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammation by increasing intracellular cAMP levels in immune and structural cells. Used for Chronic obstructive pulmonary disease (COPD) with chronic bronchitis, Asthma (investigational).
At a glance
| Generic name | Oral roflumilast |
|---|---|
| Also known as | Daxas, EU: Daxas, US: Daliresp, PDE4 inhibitor, ARQ-151 |
| Sponsor | The University of Hong Kong |
| Drug class | Phosphodiesterase-4 (PDE-4) inhibitor |
| Target | PDE-4 |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Immunology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting PDE-4, roflumilast prevents the breakdown of cyclic adenosine monophosphate (cAMP), leading to elevated cAMP concentrations in inflammatory cells such as macrophages, neutrophils, and T cells. This elevation suppresses the production of pro-inflammatory cytokines and chemokines, thereby reducing airway inflammation and mucus production. The drug is used to modulate chronic inflammatory airway diseases by dampening the underlying inflammatory cascade.
Approved indications
- Chronic obstructive pulmonary disease (COPD) with chronic bronchitis
- Asthma (investigational)
Common side effects
- Nausea
- Diarrhea
- Headache
- Weight loss
- Vomiting
- Tremor
Key clinical trials
- Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD
- A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD (PHASE2)
- Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study (PHASE2)
- A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults (PHASE2)
- Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata (PHASE4)
- Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) (PHASE1)
- Role of Roflumilast in Ulcerative Colitis (PHASE4)
- Roflumilast in Non-CF Bronchiectasis Study (2019) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oral roflumilast CI brief — competitive landscape report
- Oral roflumilast updates RSS · CI watch RSS
- The University of Hong Kong portfolio CI