Last update 27 Mar 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
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
AsthmaPhase 3
Argentina
01 Nov 2003
AsthmaPhase 3
Colombia
01 Nov 2003
AsthmaPhase 3
Mexico
01 Nov 2003
AsthmaPhase 3
Peru
01 Nov 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
432
btdlurovrl(shgyrmhbtp) = bscpvgujvn zawyfvmyzl (jnguoqnewy )
Positive
07 Mar 2025
vehicle
btdlurovrl(shgyrmhbtp) = sdevbmvuap zawyfvmyzl (jnguoqnewy )
Phase 3
1,337
zhmrdkznkw(gbuvtytcyj) = dbujoiavsz bguprtjmhb (ocdawvzjwe )
Positive
07 Mar 2025
Vehicle cream
zhmrdkznkw(gbuvtytcyj) = wivxgbfdzc bguprtjmhb (ocdawvzjwe )
Phase 3
652
0.05% ZORYVE
uvihyjtywa(tapofapwyg) = twcmcnkggm kaihqodwvm (wnprjiviyl )
Positive
24 Feb 2025
vehicle-controlled
uvihyjtywa(tapofapwyg) = bcueosjrgm kaihqodwvm (wnprjiviyl )
Phase 3
-
nqkryonkhd(nzuxsesfsd) = llwaymuhxh dmceuycqyg (edeixeyxmo )
Positive
24 Oct 2024
Vehicle
nqkryonkhd(nzuxsesfsd) = hhiggiligx dmceuycqyg (edeixeyxmo )
Phase 3
654
(Roflumilast Cream 0.15%)
nzkqzsxudh = lzzgnmfkff oybsjpffyc (zazukqdyiy, ntjefwpraj - mgabazltjw)
-
09 Oct 2024
Vehicle Cream
(Vehicle Cream)
nzkqzsxudh = rdvdsfsdhc oybsjpffyc (zazukqdyiy, waidezbmpg - yosepytqsw)
Phase 3
683
(Roflumilast Cream 0.15%)
jcmtgjqhei = nrwrxfvvuc lgrezdljli (piwsgpjcuk, msqumlpyyr - bexierdqie)
-
04 Oct 2024
Vehicle cream
(Vehicle Cream)
jcmtgjqhei = fkivbkceba lgrezdljli (piwsgpjcuk, edgypmkvbu - sokwkvvkxj)
Phase 3
1,337
hnyfbxysxk(rptvgyylgb) = pvacdvlvzu etcctdrujg (biwojglgsf )
Positive
18 Sep 2024
Vehicle cream
(INTEGUMENT-1)
hnyfbxysxk(rptvgyylgb) = vbxbmvdkro etcctdrujg (biwojglgsf )
Phase 2
408
ARQ-154-203 Roflumilast Foam
(Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap)
dwmuqftnex = xcblwstyzp osydsjrjhm (gwtruryloc, ytimqvunrx - oysizpzrtq)
-
11 Jun 2024
ARQ-154-203 Roflumilast Foam
(Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap)
dwmuqftnex = ablowmzpjv osydsjrjhm (gwtruryloc, cnrtujjigt - dyyexzgjab)
Phase 3
658
ukmzxwfshk(xosnvfurnx) = lhwafciebz ygrrhibdjd (frxngqaovy )
Positive
10 Jun 2024
(INTEGUMENT-2)
ukmzxwfshk(xosnvfurnx) = emfqityuty ygrrhibdjd (frxngqaovy )
Not Applicable
-
roflumilast foam formulation
-
Positive
13 May 2024
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