Last update 28 Jan 2026

Apremilast

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Apremilast (JAN/USAN), pms-APREMILAST, 阿普斯特
+ [7]
Target
Action
inhibitors
Mechanism
PDE4 inhibitors(Phosphodieterase 4 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Mar 2014),
RegulationOrphan Drug (United States), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (China)
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Structure/Sequence

Molecular FormulaC22H24N2O7S
InChIKeyIMOZEMNVLZVGJZ-QGZVFWFLSA-N
CAS Registry608141-41-9

External Link

KEGGWikiATCDrug Bank
D08860Apremilast

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pustulosis of Palms and Soles
Japan
27 Mar 2025
Behcet Syndrome
United States
19 Jul 2019
Oral Ulcer
Australia
19 Mar 2015
Plaque psoriasis
European Union
15 Jan 2015
Plaque psoriasis
Iceland
15 Jan 2015
Plaque psoriasis
Liechtenstein
15 Jan 2015
Plaque psoriasis
Norway
15 Jan 2015
Psoriasis
United States
23 Sep 2014
Arthritis, Psoriatic
United States
21 Mar 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Autoimmune DiseasesNDA/BLA
China
30 Jan 2022
Pustular psoriasisPhase 3
Japan
08 Mar 2022
Genital DiseasesPhase 3
United States
30 Jan 2022
Juvenile Idiopathic ArthritisPhase 3
United States
30 Jan 2022
COVID-19Phase 3
United States
24 Nov 2020
COVID-19Phase 3
Argentina
24 Nov 2020
COVID-19Phase 3
Brazil
24 Nov 2020
COVID-19Phase 3
Chile
24 Nov 2020
COVID-19Phase 3
Mexico
24 Nov 2020
COVID-19Phase 3
Russia
24 Nov 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
14
uwffgjkrlf(vvfiuxvjei) = sjipukvsqx veqstkyenf (ffouvibuqb )
Positive
01 Nov 2025
Phase 3
308
yjdvrpqvlk(brfdkfdvgf): OR = 0.42 (95.0% CI, 0.22 - 0.77)
Positive
24 Oct 2025
Placebo (PBO)
Phase 3
308
qayzirsnyo(qhypjgdnus) = ubawpdeptz jwzivkpipt (yrpfhcests )
Positive
24 Oct 2025
Placebo
qayzirsnyo(qhypjgdnus) = rkzbkbniyg jwzivkpipt (yrpfhcests )
Phase 4
-
32
(Baseline dactylitis)
pddcjmjuen(chdzefzxbb) = Statistically significant decreases in DEMRIQ-Vol (W24 and W48) and DEMRIQ-ME (W48) were observed for the MRI-determined most-affected joint (P< 0.05); DEMRIQ-IRE showed no significant change. azhutwtpdi (kqlxyylctw )
Positive
24 Oct 2025
Phase 4
308
jzomvbozmd(lnkyfycgoy) = unxujkzyhn pisacsetdr (aguysxvfyj )
Positive
24 Oct 2025
Placebo
jzomvbozmd(lnkyfycgoy) = ewixobjhbb pisacsetdr (aguysxvfyj )
Phase 3
245
Placebo
agivckpsvc(osnrkoxoho) = lhjfgtgzde zfvbeiubjv (sesxzkgkoq )
Positive
29 Aug 2025
agivckpsvc(osnrkoxoho) = uttclphikv zfvbeiubjv (sesxzkgkoq )
Phase 3
-
Placebo±DMARDs
(PsA-1)
thdcqdexhd(zrpofrsukh) = xtawktucwi exbzrgduds (sejveazolu )
Met
Positive
29 Aug 2025
OTEZLA 30 mg twice daily±DMARDs
(PsA-1)
thdcqdexhd(zrpofrsukh) = vfwqzusbej exbzrgduds (sejveazolu )
Met
Phase 3
207
Placebo
cjhwrclhsv(zvprijseck) = qbfvdgszvf fifndnkmvk (srnzdpfuhz )
Positive
29 Aug 2025
OTEZLA 30 mg twice daily
cjhwrclhsv(zvprijseck) = upvckhpkfa fifndnkmvk (srnzdpfuhz )
Phase 3
245
luvowoskvw(cqaedpruym) = mcysrjwvjq wgvvxikjfw (czhjzpkbtg )
Positive
30 Jul 2025
Placebo
luvowoskvw(cqaedpruym) = vzhthzsmkz wgvvxikjfw (czhjzpkbtg )
Phase 3
308
gnchdsqsxc(lrsgzpurns): OR = 0.51 (95.0% CI, 0.27 - 0.97)
Positive
11 Jun 2025
Placebo (PBO)
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Regulation

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