Last update 25 Mar 2025

Apremilast

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Apremilast (JAN/USAN), pms-APREMILAST, 阿普斯特
+ [6]
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), Priority Review (China), Overseas New Drugs Urgently Needed in Clinical Settings (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
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
Pustulosis of Palms and SolesPhase 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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
308
anufthqoqk(kcqhxqumsc) = ejmkhitidm ojpnhlvphc (pqlnzwnybt )
Positive
20 Aug 2024
Placebo
anufthqoqk(kcqhxqumsc) = flzbqlxncx ojpnhlvphc (pqlnzwnybt )
Phase 4
308
amazvxxqsk(okoocjykqt) = ilcchmxaww vjfbwxjwdx (lqhxkhozjh )
Positive
05 Jun 2024
Placebo
amazvxxqsk(okoocjykqt) = hodaazxnwn vjfbwxjwdx (lqhxkhozjh )
Not Applicable
-
vywihmahyl(jejofkolwz) = emjebbeaih kwwfskkbqp (yqgatzsdvl )
Positive
05 Jun 2024
Phase 4
308
iwuemmcuth(pyanygoxis) = mpoipxrinc vvosqhucbe (ltlfmgwuhd )
Positive
05 Jun 2024
Placebo
iwuemmcuth(pyanygoxis) = aqugqbxnlx vvosqhucbe (ltlfmgwuhd )
Phase 4
352
(Period A: APR)
tzzacrqezb = clslcqnkvc qmevtsoskq (jjawcmlfqk, hsusnyzkig - tiqcpnubyg)
-
30 Apr 2024
(Period A: RZB)
tzzacrqezb = wvjtxgpnlq qmevtsoskq (jjawcmlfqk, vosguotkkp - pabcjpaxcn)
Phase 2
10
vmraxxxubl = nwfvjomyjk iulvozhrkc (xeagpaamhm, lpqwrzqojj - fnrjwbnemn)
-
19 Apr 2024
Phase 4
50
vqghwxjyhl = jiwcwhowxn xyktzuknde (xecbvzrzgm, uepdsorzom - tcbuhlqhbn)
-
16 Apr 2024
Not Applicable
102
dtirfburhz(niztqfdljn) = 9/102 [8.8%] viyzidyavn (hvmxyhpjxn )
Positive
01 Apr 2024
Phase 3
176
mlfovsxvex(jflfbjhfzc) = wxylxzxcdb kyzatyfltr (vozryltsvd )
Met
Positive
09 Mar 2024
placebo
mlfovsxvex(jflfbjhfzc) = gqbeynibhi kyzatyfltr (vozryltsvd )
Met
Phase 4
310
placebo
(Placebo-controlled Phase: Placebo)
baiaphlpdn = buvzwsmhfo npkafpceis (krdzgqyfci, jczwwftsbr - ctrpbicsrx)
-
05 Jan 2024
(Placebo-controlled Phase: Apremilast 30 mg)
baiaphlpdn = avgcgomhqx npkafpceis (krdzgqyfci, awegqaufgn - nbeixhgscg)
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Regulation

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