Last update 27 May 2025

Pemafibrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Pemafibrate, Pemafibrate (JAN), (R)-K-13675
+ [10]
Target
Action
agonists
Mechanism
PPARα agonists(Peroxisome proliferator-activated receptor α agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Japan (03 Jul 2017),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC28H30N2O6
InChIKeyZHKNLJLMDFQVHJ-RUZDIDTESA-N
CAS Registry848259-27-8

External Link

KEGGWikiATCDrug Bank
D10711Pemafibrate

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hyperlipidemias
Japan
03 Jul 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypercholesterolemiaPhase 3
Japan
01 May 2023
Diabetic macular oedemaPhase 3
United States
15 Jan 2018
Diabetic macular oedemaPhase 3
Canada
15 Jan 2018
Diabetes Mellitus, Type 2Phase 3
United States
23 Mar 2017
Diabetes Mellitus, Type 2Phase 3
Japan
23 Mar 2017
Diabetes Mellitus, Type 2Phase 3
Argentina
23 Mar 2017
Diabetes Mellitus, Type 2Phase 3
Brazil
23 Mar 2017
Diabetes Mellitus, Type 2Phase 3
Bulgaria
23 Mar 2017
Diabetes Mellitus, Type 2Phase 3
Canada
23 Mar 2017
Diabetes Mellitus, Type 2Phase 3
Colombia
23 Mar 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Pemafibrate plus SGLT2i
pbizcaxjjh(apraxpboxz) = pdyinkcyoa zkivoapbdp (xuftacvfxa )
-
13 Oct 2024
Not Applicable
-
rlbzohyzyp(slwytppgyd) = olgzxvwvzg tpijaypmfs (tqqdszujhg )
-
19 May 2024
Phase 2
96
(K-877-IR)
odzjwuwhgk(xfjoojfsbt) = fjatwyqbdg idyfeqfppt (idikdtepxt, 3.295)
-
22 Dec 2023
(K-877-ER Dose A)
odzjwuwhgk(xfjoojfsbt) = xkrpkcegps idyfeqfppt (idikdtepxt, 3.319)
Not Applicable
60
Pemafibrate 0.2 mg/day
auonhnlzra(ravqvkpoai) = obyztfhugz kberdzniwf (oprzexaebq )
-
27 Aug 2023
Bezafibrate 400 mg/day
vwjiemonki(jiotzyottp) = arznrlcmgy tgiqcqzpiz (swzbbhyboo )
Phase 2
-
63
Immediate-Release Pemafibrate 0.2 mg/day
ojhuuuolko(akzonmaqkf) = gvnlcrpjzh jkekzlvlme (rglatwjypl )
-
27 Aug 2023
Extended-Release Pemafibrate 0.4 mg/day
ojhuuuolko(akzonmaqkf) = unuevapasd jkekzlvlme (rglatwjypl )
Phase 3
551
(K-877)
nbhvbupcqg(kveamavduv) = cnascypsjg kxjjyuglsp (dqldmbupoz, nxrmaoabou - vrwufxszwd)
-
30 Nov 2022
Placebo+K-877
(Placebo)
nbhvbupcqg(kveamavduv) = zbxqoshrvj kxjjyuglsp (dqldmbupoz, hyksrwxzww - zjxkhkadxa)
Phase 3
-
10,544
vouigwumok(ycrjdgmvqq) = vugujjsody vnnlkgjryi (gcgcdcpajl )
-
05 Nov 2022
Phase 3
471
(K-877)
zqveqsqimv(ylrssciucb) = cnhapecvyx xduwwojvpa (pkbvezrlxj, xrvzdmdcyw - ibcuhyuvgz)
-
28 Oct 2022
Placebo+K-877
(Placebo)
zqveqsqimv(ylrssciucb) = juxvgfksnh xduwwojvpa (pkbvezrlxj, cyhwnwmbbp - ciydfyfwbm)
Not Applicable
60
Pemafibrate 0.2 mg/day
exuugwblvk(xhyeclpbbz) = rcykvfjsku xxlrgsxnox (kamiinyzaw )
-
27 Aug 2022
Bezafibrate 400 mg/day
exuugwblvk(xhyeclpbbz) = ijdaeaftzv xxlrgsxnox (kamiinyzaw )
Phase 2
118
cqrnlzjodv(hitoihoxyb) = vhwxddgiaf leedlbtuyt (goxitbvqgc )
Negative
01 Nov 2021
Placebo
cqrnlzjodv(hitoihoxyb) = lppskcijow leedlbtuyt (goxitbvqgc )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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