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Roflumilast · Daliresp, Zoryve

Small molecule · Inhibitor of phosphodiesterase 4 (PDE4) · developed by Astrazeneca

Approved FDA, Feb 2011
17 Registered trials

What is Roflumilast?

Roflumilast is a phosphodiesterase 4 (PDE4) inhibitor that blocks breakdown of cyclic AMP, raising intracellular cyclic AMP levels. It is applied topically as a cream or foam and is studied in inflammatory skin conditions including hidradenitis suppurativa, vitiligo, seborrheic dermatitis, pruritus and atopic dermatitis.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Daliresp, Zoryve, ARQ-151, B-9302-107
Drug type
Small molecule
Targets
phosphodiesterase 4 (PDE4)
Mechanism
Inhibitor of phosphodiesterase 4 (PDE4)
Pathways
cyclic AMP accumulation
Therapy area
Dermatology
Developer
Astrazeneca
In trials of
ARQT
FDA status
Approved as Daliresp, Zoryve (February 28, 2011), NDA022522 · FDA label
UNII
0P6C6ZOP5U

✅ FDA-approved uses

From the indications section of the FDA label (version of Jul 20, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT07560618 Phase 4 ITCH Recruiting ARQT
NCT07683806 Phase 3 Seborrheic Dermatitis Not yet recruiting ARQT
NCT04973228 Phase 3 Seborrheic Dermatitis Completed ARQT
NCT04845620 Phase 3 Atopic Dermatitis Eczema Completed ARQT
NCT04804605 Phase 3 Atopic Dermatitis Eczema Completed ARQT
NCT04773600 Phase 3 Atopic Dermatitis Eczema Completed ARQT
NCT04286607 Phase 3 Chronic Plaque Psoriasis Completed ARQT
NCT04211363 Phase 3 Chronic Plaque Psoriasis Completed ARQT
NCT04211389 Phase 3 Chronic Plaque Psoriasis Completed ARQT
NCT07077902 Phase 2 Hidradenitis Suppurativa Recruiting ARQT
NCT07105254 Phase 2 Non-segmental Vitiligo Recruiting ARQT
NCT06998056 Phase 2 Atopic Dermatitis (Eczema) Completed ARQT
NCT04746911 Phase 2 Psoriasis Completed ARQT
NCT03764475 Phase 2 Plaque Psoriasis Completed ARQT
NCT03638258 Phase 2 Plaque Psoriasis Completed ARQT
NCT03392168 Phase 1/2 Psoriasis Completed ARQT
NCT04279119 Phase 1 Plaque Psoriasis Completed ARQT

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Atopic DermatitisHidradenitis SuppurativaITCHNon-segmental VitiligoAtopic Dermatitis (Eczema)Chronic Plaque PsoriasisPlaque PsoriasisPsoriasisSeborrheic Dermatitis

Sources

Updated Oct 11, 2026.

Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.