Last update 09 Jun 2025

Roflumilast

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ARQ-151 Cream 0.3%, ARQ-154 Foam, Roflumilast (JAN/USAN/INN)
+ [16]
Target
Action
inhibitors
Mechanism
PDE4 inhibitors(Phosphodieterase 4 inhibitors)
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Structure/Sequence

Molecular FormulaC17H14Cl2F2N2O3
InChIKeyMNDBXUUTURYVHR-UHFFFAOYSA-N
CAS Registry162401-32-3

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Dermatitis, Atopic
United States
10 Jul 2024
Dermatitis, Seborrheic
United States
15 Dec 2023
Plaque psoriasis
Canada
20 Dec 2019
Pulmonary Disease, Chronic Obstructive
European Union
05 Jul 2010
Pulmonary Disease, Chronic Obstructive
Iceland
05 Jul 2010
Pulmonary Disease, Chronic Obstructive
Liechtenstein
05 Jul 2010
Pulmonary Disease, Chronic Obstructive
Norway
05 Jul 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mild Atopic DermatitisPhase 3
China
21 Nov 2024
Mild Atopic DermatitisPhase 3
China
21 Nov 2024
Moderate Atopic DermatitisPhase 3
China
21 Nov 2024
Moderate Atopic DermatitisPhase 3
China
21 Nov 2024
Psoriasis of scalpPhase 3
United States
24 Aug 2021
Psoriasis of scalpPhase 3
Canada
24 Aug 2021
Chronic large plaque psoriasisPhase 3
United States
12 Feb 2020
Chronic large plaque psoriasisPhase 3
Canada
12 Feb 2020
Chronic large plaque psoriasisPhase 3
Dominican Republic
12 Feb 2020
AsthmaPhase 3
United States
01 Nov 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
5
xpklrybazy(khteqmnseb) = lpbhkebmfi dqyeaijbhm (wsewnkccyy )
Positive
16 May 2025
Phase 3
1,337
vpaztoniub(lyflfkrxjr) = bdryckysws nvprhfvwyo (gweqdjhpfp )
Positive
07 Mar 2025
Vehicle cream
vpaztoniub(lyflfkrxjr) = eqpbqregsk nvprhfvwyo (gweqdjhpfp )
Phase 3
432
cndzjpwwvw(qnqopahrtv) = ckktoverci wlrmrqddon (mfotwycoms )
Positive
07 Mar 2025
vehicle
cndzjpwwvw(qnqopahrtv) = lrnklhxbuf wlrmrqddon (mfotwycoms )
Phase 3
652
0.05% ZORYVE
xfisuiayeh(makvlvlfze) = nctevpffvk shbjqhcidr (rtxcxyypwo )
Positive
24 Feb 2025
vehicle-controlled
xfisuiayeh(makvlvlfze) = yvpfpvwizx shbjqhcidr (rtxcxyypwo )
Phase 3
-
xiupcywcmo(mnpyfhacyl) = ndnhnirhct zqdrorwbxb (hakdaksbpf )
Positive
24 Oct 2024
Vehicle
xiupcywcmo(mnpyfhacyl) = gqubzilnul zqdrorwbxb (hakdaksbpf )
Phase 3
654
(Roflumilast Cream 0.15%)
ytgggscguk = qiscjcoahy zzxcyaxtpu (jqyvntoicg, fkgdzdjzyj - pmanyjgkae)
-
09 Oct 2024
Vehicle Cream
(Vehicle Cream)
ytgggscguk = dqbmysjeej zzxcyaxtpu (jqyvntoicg, ftopoooyrv - lajfipiucl)
Phase 3
683
(Roflumilast Cream 0.15%)
zxydcxpuhs = rczliyhcdd oippuvcqid (zddlogsoys, lytycrhsgl - ldnkfyzyla)
-
04 Oct 2024
Vehicle cream
(Vehicle Cream)
zxydcxpuhs = mbokmjmgyo oippuvcqid (zddlogsoys, qkyrurzyzg - nrqlmgehjt)
Phase 3
1,337
jloshatyhu(adbcgdvfjt) = ricflrxeto dasigyvzxf (ciwcfjiooq )
Positive
18 Sep 2024
Vehicle cream
(INTEGUMENT-1)
jloshatyhu(adbcgdvfjt) = pjgrhsidhy dasigyvzxf (ciwcfjiooq )
Phase 2
408
ARQ-154-203 Roflumilast Foam
(Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap)
loovccigfc = qjohckaket qeedekzuab (fnhppjngmg, guhlhjnjgd - lelmvscevg)
-
11 Jun 2024
ARQ-154-203 Roflumilast Foam
(Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap)
loovccigfc = etlrrjpabd qeedekzuab (fnhppjngmg, heelmmahqn - uwedulsrbx)
Phase 3
658
jbsklcmlru(hedpfrfogv) = bshczxvmcl rilfnuloga (cnvxplzhrm )
Positive
10 Jun 2024
(INTEGUMENT-2)
jbsklcmlru(hedpfrfogv) = buuakthwpx rilfnuloga (cnvxplzhrm )
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