Last reviewed · How we verify
Roflumilast 500
Roflumilast 500 is a Small molecule drug developed by Spanish Research Center for Respiratory Diseases. It is currently FDA-approved.
Roflumilast 500 is a small molecule inhibitor of the enzyme phosphodiesterase 4. It is used to treat Chronic Obstructive Pulmonary Disease (COPD) as per a multicenter randomized double-blind clinical study.
At a glance
| Generic name | Roflumilast 500 |
|---|---|
| Sponsor | Spanish Research Center for Respiratory Diseases |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) (PHASE4)
- 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)
- The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients (PHASE1, PHASE2)
- 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:
- Roflumilast 500 CI brief — competitive landscape report
- Roflumilast 500 updates RSS · CI watch RSS
- Spanish Research Center for Respiratory Diseases portfolio CI
Frequently asked questions about Roflumilast 500
What is Roflumilast 500?
Who makes Roflumilast 500?
What development phase is Roflumilast 500 in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing