Roflumilast is marketed as DALIRESP, an oral selective phosphodiesterase-4 inhibitor used to reduce the risk of COPD exacerbations in severe COPD associated with chronic bronchitis and prior exacerbations. Labeling specifies that it is not a bronchodilator for acute bronchospasm. U.S. initial approval was in 2011.
Arcutis is in focus after new Phase 3 extension data for Zoryve cream 0.05% in young children with atopic dermatitis and ahead of its Feb. 25 Q4 results. Investors are also watching recent FDA actions and pipeline updates for additional pediatric and dermatology indications.
The FDA has approved topical difamilast, a PDE4 inhibitor, for treating mild-to-moderate atopic dermatitis in adults and children aged 2 years or older, marking the third PDE4 inhibitor approval for this indication.
Arcutis Biotherapeutics is scheduled to report fourth-quarter and full-year 2025 results on Feb. 25, after market close. Investors will focus on sales performance of Zoryve and pipeline updates.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07566351 |
Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis |
RECRUITING | PHASE2 |
| NCT07352566 |
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
NOT_YET_RECRUITING | PHASE4 |
| NCT07174011 |
Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata |
COMPLETED | PHASE4 |
| NCT06977711 |
Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) |
RECRUITING | PHASE1 |
| NCT06860958 |
Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients |
RECRUITING | PHASE3 |
| NCT06457191 |
Roflumilast and TMS Motor Plasticity |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06440473 |
Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin |
RECRUITING | PHASE4 |
| NCT05884281 |
Efficacy of Roflumilast in Prevention of Peripheral Neuropathy |
UNKNOWN | PHASE1/PHASE2 |
| NCT05684744 |
Roflumilast Versus Methotrexate in Psoriasis |
COMPLETED | PHASE2/PHASE3 |
| NCT05418049 |
Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge |
ACTIVE_NOT_RECRUITING | PHASE2 |
