Last update 21 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),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (US), 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
IS
15 Jan 2015
Plaque psoriasis
LI
15 Jan 2015
Plaque psoriasis
NO
15 Jan 2015
Plaque psoriasis
EU
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
Arthritis, PsoriaticPhase 1
CN
03 Feb 2021
Ankylosing SpondylitisPhase 1
RO
02 May 2012
Ankylosing SpondylitisPhase 1
RU
02 May 2012
Ankylosing SpondylitisPhase 1
CZ
02 May 2012
Ankylosing SpondylitisPhase 1
SK
02 May 2012
Ankylosing SpondylitisPhase 1
CA
02 May 2012
Ankylosing SpondylitisPhase 1
NL
02 May 2012
Plaque psoriasisPhase 1-09 Sep 2010
SarcoidosisPhase 1
US
01 Nov 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
308
(ggecstdzxt) = wefvpputxk lfenlnzwgz (cjjuzqitjm )
Positive
20 Aug 2024
Placebo
(ggecstdzxt) = rqouxewacv lfenlnzwgz (cjjuzqitjm )
Not Applicable
-
rrnqomdluf(oerqshjptd) = cjfxcohndg mrtcfbkvsv (ykluqcecqp )
Positive
05 Jun 2024
Phase 4
308
wpwqacnphq(zibcfrvldp) = ghoefuyvwz zwuitzbaee (ucgmdlzzfs )
Positive
05 Jun 2024
Placebo
wpwqacnphq(zibcfrvldp) = wcinkklbyv zwuitzbaee (ucgmdlzzfs )
Phase 4
308
dwrlknlhvj(fwamdlyndy) = klafgprhtk rmgfwdrste (fkdhkfjtep )
Positive
05 Jun 2024
Placebo
dwrlknlhvj(fwamdlyndy) = lqhdwrfwsh rmgfwdrste (fkdhkfjtep )
Not Applicable
-
TNF inhibitors
njbpuvawoz(wsvcxugcky) = goteewdhdn gmwmlyycfz (ljaucqgkls )
Positive
05 Jun 2024
njbpuvawoz(wsvcxugcky) = ozklqdhbun gmwmlyycfz (ljaucqgkls )
Phase 4
352
(Period A: APR)
xzgzfnmcej(zwyxxogkgb) = pgsztvyvhl xwljicfsal (dkskpckwyx, nkxwtkfmxd - ehmxktuyyo)
-
30 Apr 2024
(Period A: RZB)
xzgzfnmcej(zwyxxogkgb) = ttiuhuajjg xwljicfsal (dkskpckwyx, rzdpqxjjmp - uqzwwkckpp)
Phase 2
10
dciiewiedf(dufshoitob) = zguzfuvkjk zwkoqunbsp (adhaqivcgz, jghojyovzf - bmsumssudh)
-
19 Apr 2024
Phase 4
50
evleyyznua(ozamrfikcq) = gsadrruqjt huwqnvhnwa (ywmzzhkhiy, auwqwsjjll - ekegyliqiu)
-
16 Apr 2024
Not Applicable
102
rnzbjfmxvb(oiyjhoqujd) = 9/102 [8.8%] qwcdbooimc (hcxsplpthk )
Positive
01 Apr 2024
Phase 3
176
(fbphcqkcpq) = aoqhvmzbwq taxzjynblu (gfjllhlgep )
Met
Positive
09 Mar 2024
placebo
(fbphcqkcpq) = uconaiwoxl taxzjynblu (gfjllhlgep )
Met
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Regulation

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