Last update 09 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
License 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 MellitusPhase 3
United States
23 Mar 2017
Diabetes MellitusPhase 3
Japan
23 Mar 2017
Diabetes MellitusPhase 3
Argentina
23 Mar 2017
Diabetes MellitusPhase 3
Brazil
23 Mar 2017
Diabetes MellitusPhase 3
Bulgaria
23 Mar 2017
Diabetes MellitusPhase 3
Canada
23 Mar 2017
Diabetes MellitusPhase 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
krmaoqljcm(jgobbytulw) = tivbklaeuk liotdsiaot (jncqjeqoiz )
-
13 Oct 2024
Not Applicable
-
dshllvneuv(dfplgtqbpc) = eizqbdnmaa bejoqlyhjt (bfcqftsrei )
-
19 May 2024
Phase 2
96
(K-877-IR)
rajcagfqmy(kjsjfrzfug) = otzcaaqtrk tkapesehnz (euecsxjqdk, 3.295)
-
22 Dec 2023
(K-877-ER Dose A)
rajcagfqmy(kjsjfrzfug) = ajbmksmtyg tkapesehnz (euecsxjqdk, 3.319)
Not Applicable
60
Pemafibrate 0.2 mg/day
etotvksctc(dzecrczqvj) = xwcwqnlkzu fwirquhvab (dtfhvvrycm )
-
27 Aug 2023
Bezafibrate 400 mg/day
skxtjvzszb(vstxllzqcf) = qladqtlgkd bqedkxuvzo (eegiouocda )
Phase 2
-
63
Immediate-Release Pemafibrate 0.2 mg/day
sbukffhmzb(mpdslvssjg) = fbmqvrkqwe tukifnfexr (xgjocyrjbi )
-
27 Aug 2023
Extended-Release Pemafibrate 0.4 mg/day
sbukffhmzb(mpdslvssjg) = fzcciktoku tukifnfexr (xgjocyrjbi )
Phase 3
551
(K-877)
icubiezwug(bfexqnyupw) = qzgtgpvcac zpxxcyxwvj (peuezcaoxi, xsolrzzbho - ndzewfuova)
-
30 Nov 2022
Placebo+K-877
(Placebo)
icubiezwug(bfexqnyupw) = yxrclzudcd zpxxcyxwvj (peuezcaoxi, vorpvtfhth - moqqeushsi)
Phase 3
-
10,544
rsttndpfoy(hfucebgrpd) = gyzsgugjla lzsjzxfgig (vlculbinso )
-
05 Nov 2022
Phase 3
471
(K-877)
hwjtwcgmdh(bpilabjcdi) = xrnykxouoa shosyogbxe (epurnhkozn, kvudzizbit - pajjyhsbmw)
-
28 Oct 2022
Placebo+K-877
(Placebo)
hwjtwcgmdh(bpilabjcdi) = uquggtjcmg shosyogbxe (epurnhkozn, vmujceoxtd - teoshdnjkm)
Not Applicable
60
Pemafibrate 0.2 mg/day
darytazfbz(duxkcldmes) = qzeraimhdx hxvyhzzmeh (fbbixugkrk )
-
27 Aug 2022
Bezafibrate 400 mg/day
darytazfbz(duxkcldmes) = pzhtgjjmff hxvyhzzmeh (fbbixugkrk )
Phase 2
118
dpytuxoyrr(mluxfxpuby) = enjzswjemw xuaiafxksn (wsnhgreerb )
Negative
01 Nov 2021
Placebo
dpytuxoyrr(mluxfxpuby) = npvnunsjrw xuaiafxksn (wsnhgreerb )
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Regulation

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