Drugs / K-877
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | hyperlipidemia | — | “国内で製造販売承認申請を行った選択的PPARαモジュレーター （高脂血症治療剤）「K-877（開発コード）」（一般名：ペマフィブラート）” kowa.co.jp ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT04742218 | Jan → Apr 2021 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04237597 | Dec 2019 → Jan 2020 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03702673 | Oct → Nov 2018 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02922465 | Sep → Oct 2016 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02719431 | Jan → Feb 2016 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02275962 | Sep → Oct 2014 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02273986 | Aug → Sep 2014 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02275975 | Jul → Aug 2014 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02276001 | Jun → Jul 2014 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02275988 | Jun → Aug 2014 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02073084 | Jan → Mar 2014 | hyperlipidemia | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06623539 | Dec 2020 → Jun 2025 overdue | NAFLD1 | Yokohama City University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04447820 | Jun → Dec 2020 | hyperlipidemia | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04079530 | Sep → Dec 2019 | hyperlipidemia | Kowa Company, Ltd. | Completed | Met primary |
| Phase 2 | NCT03350165 | Dec 2017 → Apr 2019 | NAFLD1 | Kowa Company, Ltd. | Completed | Missed primary |
| Phase 36 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT05923281 | May 2023 → Aug 2024 | hyperlipoproteinemia | Kowa Company, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04998981 | Sep 2021 → Feb 2023 | hyperlipidemia | Kowa Company, Ltd. | Completed | Met primary |
| Phase 3 | NCT04714151 | Feb → Sep 2021 | hyperlipidemia | Kowa Company, Ltd. | Completed | Met primary |
| Phase 3 | NCT04716595 | Feb 2021 → Jun 2022 | hyperlipidemia | Kowa Company, Ltd. | Completed | Met primary |
| Phase 3 | NCT03345901 | Jan 2018 → Apr 2019 | diabetic macular edema | Jaeb Center for Health Research | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03071692 | Mar 2017 → Jul 2022 | hyperlipidemia, type 2 diabetes mellitus | Kowa Research Institute, Inc. | Terminated | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07634484 | Jul 2026 → Jul 2027 expected | hyperlipidemia | Kowa Company, Ltd. | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07562178 | May 2026 → Mar 2028 expected | hypertriglyceridemia, intracranial arterial disease | Tokyo Women's Medical University | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT03001817 Comparator | Nov 2016 → Jun 2019 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03011450 Comparator | Nov 2016 → Jul 2019 | — | Kowa Research Institute, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2017-07-18 | Kowa Research Institute, Inc. | Regulatory 高脂血症治療剤「パルモディア錠0.1mg」の国内での製造販売承認取得について kowa.co.jp ↗
興和株式会社（本社：名古屋市中区、社⻑：三輪 弘、以下「興和」）は、世界に 先駆けて製造販売承認申請を⾏っていた⾼脂⾎症治療剤「パルモディア ®錠0 . 1 m g （⼀般名：ペマフィブラート）」（以下、本剤）について、2017 年 7 ⽉ 3 ⽇付で厚⽣ 労働省より国内での製造販売承認を取得しました。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-07-18 | Kowa Research Institute, Inc. | 高脂血症治療剤「パルモディア錠0.1mg」の国内での製造販売承認取得について kowa.co.jp ↗ |
| 2016-01-12 | Kowa Research Institute, Inc. | 高脂血症治療剤「K-877」の心血管疾患発症・再発予防を目的としたグローバル臨床試験に係る業務委受託契約の締結について kowa.co.jp ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | K-877 | “K-877 (pemafibrate) tablet twice daily.” NCT03071692 ↗ |
| Known as | Pemafibrate | “Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, reduces triglyceride levels and improves other lipid levels.” PMID 36342113 ↗ Nov 20225“Pemafibrate, a selective PPARα modulator (SPPARMα), improves cholestatic liver enzymes in primary biliary cholangitis (PBC).” PMID 42458967 ↗ Jul 2026 |
| Action | Activate | “selectively increasing peroxisome proliferator-activated receptor alpha (PPARα) activity” NCT03345901 ↗ |
| Route | Oral | “K-877 & Clopidogrel orally” NCT02922465 ↗ |
| Target | PPARA | “The selective peroxisome proliferator-activated receptor alpha modulator (SPPARM-α), pemafibrate, will be used to target residual cardiovascular risk remaining after treatment...” PMID 30342298 ↗ Sep 2018 |