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Roflumilast Cream 0.15%
Roflumilast is a phosphodiesterase 4 inhibitor that reduces inflammation by blocking the action of phosphodiesterase 4.
Roflumilast is a phosphodiesterase 4 inhibitor that reduces inflammation by blocking the action of phosphodiesterase 4. Used for Moderate to severe plaque psoriasis.
At a glance
| Generic name | Roflumilast Cream 0.15% |
|---|---|
| Also known as | ARQ-151 |
| Sponsor | Arcutis Biotherapeutics, Inc. |
| Drug class | Phosphodiesterase 4 inhibitor |
| Target | Phosphodiesterase 4 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Phosphodiesterase 4 is an enzyme involved in the regulation of inflammation. By inhibiting this enzyme, roflumilast reduces the production of pro-inflammatory cytokines and mediators, leading to decreased inflammation. This mechanism is particularly effective in treating skin conditions such as psoriasis and atopic dermatitis.
Approved indications
- Moderate to severe plaque psoriasis
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
Key clinical trials
- Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (PHASE3)
- Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis (PHASE3)
- Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (PHASE3)
- Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II) (PHASE3)
- Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis (PHASE2)
- The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis (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 Cream 0.15% CI brief — competitive landscape report
- Roflumilast Cream 0.15% updates RSS · CI watch RSS
- Arcutis Biotherapeutics, Inc. portfolio CI