Synonyms: ARQ-151/Zoryve® (roflumilast cream) | BY-217 | BYK-20869 | Daliresp® | Daxas®
roflumilast is an approved drug (EMA (2010), FDA (2011))
Compound class:
Synthetic organic
Comment: Roflumilast is a phosphodiesterase-4 inhibitor.
Ligand Activity Visualisation ChartsThese are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts. ✖View more information in the IUPHAR Pharmacology Education Project: roflumilast |
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No information available. |
Summary of Clinical Use |
Oral roflumilast is used to treat asthma and chronic obstructive pulmonary disease (COPD) [1]. The drug reduces and prevents worsening of the lung inflammation that causes COPD. AstraZeneca's proof-of-concept trials of topical roflumilast in patients with atopic dermatitis and psoriasis were withdrawn, for business reasons, before any participants were treated. In a licensing agreement with AstraZeneca, evaluation of topical roflumilast for dermatological inflammatory conditions has been resumed by Arcutis Biotherapeutics, who have both a roflumilast cream (ARQ-151) and roflumilast foam (ARQ-154) in clinical development. The most advanced is Phase 3 ARQ-151 for plaque psoriasis [2]. |
Clinical Trials | |||||
Clinical Trial ID | Title | Type | Source | Comment | References |
NCT03638258 | The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis | Phase 2 Interventional | Arcutis Biotherapeutics, Inc. | Six weeks of once daily roflumilast cream was superior to placebo in efficacy to clear or almost clear psoriatic lesions. Based on these positive results Arcutis Biotherapeutics have advanced topical roflumilast to Phase 3. | 2 |
NCT04286607 | Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis | Phase 3 Interventional | Arcutis Biotherapeutics, Inc. | ||
NCT04211363 | Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis | Phase 3 Interventional | Arcutis Biotherapeutics, Inc. |
External links |
For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA) |