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Roflumilast Cream 0.05%
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells.
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells. Used for Atopic dermatitis (topical), Plaque psoriasis (topical).
At a glance
| Generic name | Roflumilast Cream 0.05% |
|---|---|
| Also known as | ARQ-151 |
| Sponsor | Arcutis Biotherapeutics, Inc. |
| Drug class | Phosphodiesterase-4 (PDE-4) inhibitor |
| Target | PDE-4 |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting PDE-4, roflumilast prevents the breakdown of cyclic adenosine monophosphate (cAMP) in inflammatory cells such as macrophages and T cells, leading to decreased production of pro-inflammatory cytokines and chemokines. This mechanism reduces skin inflammation and is particularly effective in conditions characterized by excessive immune activation in the skin. The topical cream formulation delivers the drug directly to affected skin areas while minimizing systemic exposure.
Approved indications
- Atopic dermatitis (topical)
- Plaque psoriasis (topical)
Common side effects
- Application site irritation
- Application site burning
- Pruritus
- Erythema
Key clinical trials
- Open Label Extension 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-PED) (PHASE3)
- Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis (PHASE2)
- Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis (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 0.05% CI brief — competitive landscape report
- Roflumilast Cream 0.05% updates RSS · CI watch RSS
- Arcutis Biotherapeutics, Inc. portfolio CI