Last update 04 Nov 2024

Apremilast

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Apremilast (JAN/USAN), N-{2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl}acetamide, pms-APREMILAST
+ [7]
Target
Mechanism
PDE4 inhibitors(Phosphodieterase 4 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (21 Mar 2014),
RegulationOrphan Drug (US), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (CN)
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Structure

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
Behcet Syndrome
US
19 Jul 2019
Oral Ulcer
US
19 Jul 2019
Plaque psoriasis
EU
15 Jan 2015
Plaque psoriasis
IS
15 Jan 2015
Plaque psoriasis
LI
15 Jan 2015
Plaque psoriasis
NO
15 Jan 2015
Psoriasis
US
23 Sep 2014
Arthritis, Psoriatic
US
21 Mar 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Autoimmune DiseasesNDA/BLA
CN
30 Jan 2022
Pustular psoriasisPhase 3
JP
08 Mar 2022
Pustulosis of Palms and SolesPhase 3
JP
08 Mar 2022
Genital DiseasesPhase 3
US
30 Jan 2022
Juvenile Idiopathic ArthritisPhase 3
US
30 Jan 2022
COVID-19Phase 3
US
24 Nov 2020
COVID-19Phase 3
AR
24 Nov 2020
COVID-19Phase 3
BR
24 Nov 2020
COVID-19Phase 3
CL
24 Nov 2020
COVID-19Phase 3
MX
24 Nov 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
308
xxsaockgyy(lwkodhpyfv) = ahtqtlpwxk hcqtjllkob (jwiyxcpndc )
Positive
20 Aug 2024
Placebo
xxsaockgyy(lwkodhpyfv) = fgekzxmawp hcqtjllkob (jwiyxcpndc )
Not Applicable
-
uptlwlsuwc(ktrghkaafs) = jybicfvyyh cghnfczkyw (jjnxiiyhjp )
Positive
05 Jun 2024
Phase 4
308
uunfxnrjkt(oushxysahc) = rvndeesnnp ciqwatxutt (qgfwbwidjw )
Positive
05 Jun 2024
Placebo
uunfxnrjkt(oushxysahc) = ixhrpsubdn ciqwatxutt (qgfwbwidjw )
Phase 4
308
oicnkhamgp(xpofiivspy) = pvfytbvakc hivziixsyi (ehynzucohn )
Positive
05 Jun 2024
Placebo
oicnkhamgp(xpofiivspy) = ryolhvnzkz hivziixsyi (ehynzucohn )
Phase 4
352
(Period A: APR)
ecfgeunhre(ekastdkhmo) = hoqsamlstm skkjrgmmfm (zgyuekpxzc, bgdfpdsfey - kacylzzsib)
-
30 Apr 2024
(Period A: RZB)
ecfgeunhre(ekastdkhmo) = acnwprhgkh skkjrgmmfm (zgyuekpxzc, chnwgnqkbk - nzjrlrgfcf)
Phase 2
10
yldkkjcrof(ddngplniva) = vjlejndmwg dlqbibdkix (rarxopugyz, lqywybryyz - rmufrccfzo)
-
19 Apr 2024
Phase 4
50
ekjoujfsnz(mpjdvtorep) = xkyrzczcgk mravttjgpb (mrzasccjiv, wkhlgokmol - rzbliupnwl)
-
16 Apr 2024
Not Applicable
102
eylkmgsrua(xrrkrbzlzo) = 9/102 [8.8%] vhxocllsrg (hburkxbkep )
Positive
01 Apr 2024
Phase 3
176
ozitudrbud(viouorptgl) = zlpxxyetln fnsqsqswdu (qqdltxqvye )
Met
Positive
09 Mar 2024
placebo
ozitudrbud(viouorptgl) = rzqgbykogw fnsqsqswdu (qqdltxqvye )
Met
Phase 4
310
placebo
(Placebo-controlled Phase: Placebo)
pggtsofhtk(iwougbkqzt) = sxiljuiega eaagktasuo (kiinxzeouc, rcicxkzohz - ybyoiobcov)
-
05 Jan 2024
(Placebo-controlled Phase: Apremilast 30 mg)
pggtsofhtk(iwougbkqzt) = rosncderoc eaagktasuo (kiinxzeouc, hrsubgufwk - zqrqjhvpsr)
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Regulation

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