Eicosapentaenoic acid
Small molecule targets PCSK9
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | hyperlipidemia | 2021-06-22 | “高脂血症治療剤として開発を進めているMND-2119（一般名：イコサペント酸 エチル）について、本日、 厚生労働省に製造販売承認申請を行いました” mochida.co.jp ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03101540 | Aug 2011 → May 2014 | major depressive disorder | William Coryell | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT03101527 | May 2011 → Feb 2012 | major depressive disorder | William Coryell | Terminated | No outcome recorded Stop: Enrollment |
| Phase 12 trials | ||||||
| Phase 1 | NCT02103842 | Mar 2014 → Jul 2015 | muscular atrophy | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00014027 | Apr 2001 → Apr 2008 | — | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04006847 | Sep 2020 → May 2021 | chronic myeloid leukemia | Milton S. Hershey Medical Center | Terminated | No outcome recorded |
| Phase 25 trials · 1 missed | ||||||
| Phase 2 | NCT02514070 | Oct 2015 → Jul 2019 | — | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT02021669 | May 2014 → Sep 2018 | depressive disorder | Washington University School of Medicine | Completed | Missed primary |
| Phase 2 | NCT00485615 | Oct 2008 → Aug 2013 | social phobia | START Clinic for Mood and Anxiety Disorders | Completed | No outcome recorded |
| Phase 2 | NCT00167310 | Sep 2005 → Dec 2015 | bipolar disorder, coronary artery disorder, major depressive disorder, schizoaffective disorder +1 | University of Pittsburgh | Completed | No outcome recorded |
| Phase 2 | NCT00312455 | Jul 2004 → Jul 2005 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT00510692 | Nov 2006 → Apr 2008 | classic or attenuated familial adenomatous polyposis | S.L.A. Pharma AG | Completed | Met primary |
| Phase 36 trials | ||||||
| Phase 3 | NCT05796401 | Dec 2023 → Dec 2026 expected | psychotic disorder | Centre Hospitalier St Anne | Recruiting | No outcome recorded |
| Phase 3 | NCT04335032 | Jan → Nov 2021 | COVID-19 | S.L.A. Pharma AG | Unknown | No outcome recorded |
| Phase 3 | NCT04221217 | Feb 2020 → Jul 2021 | hypertriglyceridemia | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03693131 | Oct 2018 → Jun 2019 | hypertriglyceridemia | Mochida Pharmaceutical Company, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01078909 | Oct 2011 → Nov 2012 | cardiovascular disorder | Penn State University | Completed | No outcome recorded |
| Phase 3 | NCT01422317 | Sep 1995 → Dec 1997 | coronary artery disorder, myocardial infarction | Helse Stavanger HF | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03657758 | Sep 2018 → Aug 2020 | coronary artery disorder | Kobe University | Unknown | No outcome recorded |
| Phase 4 | NCT00692718 | Jul 2008 → Jun 2010 | acute myocardial infarction, heart failure | Osaka General Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00114595 | Apr 2003 → Mar 2005 | movement disorder, schizophrenia | University of Stellenbosch | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 missed | ||||||
| — | NCT01270516 | Jan 2014 → Jan 2020 | myopathy | University of Kentucky | Completed | Missed primary |
| — | NCT00825994 | Nov 2008 → Jun 2009 | depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT00976872 | Jan → Dec 2008 | — | Assaf-Harofeh Medical Center | Completed | No outcome recorded |
| — | NCT00815685 | Jul 2007 → Mar 2010 | — | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT03634644 Comparator | Nov 2017 → Mar 2019 | spermatogenic failure | Jinling Hospital, China | Unknown | No outcome recorded |
| Phase 2 | NCT03936621 Comparator | Jun 2019 → Jun 2021 | lung cancer | British Columbia Cancer Agency | Unknown | No outcome recorded |
| Phase 2 | NCT01070355 Comparator | Apr 2010 → Oct 2011 | colorectal cancer | University of Leeds | Completed | No outcome recorded |
| Phase 2 | NCT00323414 Comparator | Apr 2006 → Dec 2011 | fatty liver disease | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2/3 | NCT00432913 Comparator | Oct 2006 → Jun 2008 | adenomatous colon polyp | S.L.A. Pharma AG | Completed | No outcome recorded |
| Phase 3 | NCT01745263 Comparator | Dec 2012 → Nov 2017 | — | University of Zurich | Completed | No outcome recorded |
| Phase 3 | NCT00345176 Comparator | Sep 2006 → Oct 2012 | age-related macular degeneration, cataract | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 4 | NCT03192579 Comparator | Jul 2013 → Jun 2017 | coronary atherosclerosis | Kobe University | Completed | No outcome recorded |
| — | NCT00256412 Comparator | Oct 2005 → Oct 2007 | major depressive disorder | University of Iowa | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-08-18 | Mochida Pharmaceutical Company, Ltd. | Regulatory 自己乳化型新規高純度EPA製剤「エパデールEMカプセル」の薬価基準収載ならびに新発売のお知らせ mochida.co.jp ↗
本日、 薬価基準に収載され、 9 月12 日に発売することをお知らせいたします。 |
| 2022-06-20 | Mochida Pharmaceutical Company, Ltd. | Regulatory 自己乳化型新規高純度EPA製剤「エパデールEMカプセル」の日本における製造販売承認取得のお知らせ mochida.co.jp ↗ |
| 2021-06-22 | Mochida Pharmaceutical Company, Ltd. | Regulatory 新規高純度EPA製剤「MND-2119」の日本における製造販売承認申請のお知らせ mochida.co.jp ↗ |
| 2020-11-24 | Mochida Pharmaceutical Company, Ltd. | Regulatory タイにおけるエパデールの承認取得のお知らせ mochida.co.jp ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-08-18 | Mochida Pharmaceutical Company, Ltd. | 自己乳化型新規高純度EPA製剤「エパデールEMカプセル」の薬価基準収載ならびに新発売のお知らせ mochida.co.jp ↗ |
| 2022-06-20 | Mochida Pharmaceutical Company, Ltd. | 自己乳化型新規高純度EPA製剤「エパデールEMカプセル」の日本における製造販売承認取得のお知らせ mochida.co.jp ↗ |
| 2021-06-22 | Mochida Pharmaceutical Company, Ltd. | 新規高純度EPA製剤「MND-2119」の日本における製造販売承認申請のお知らせ mochida.co.jp ↗ |
| 2020-11-24 | Mochida Pharmaceutical Company, Ltd. | タイにおけるエパデールの承認取得のお知らせ mochida.co.jp ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eicosapentaenoic Acid | “Daily supplementation with long-chain ω-3 polyunsaturated fatty acids (350-mg docosahexaenoic acid [DHA] + 650-mg eicosapentaenoic acid [EPA]), macular xanthophylls (10-mg...” PMID 24638908 ↗ May 201429“Eicosapentaenoic acid (EPA) is another lipid-lowering therapyAccording to a recent study, the addition of highly purified EPA to statin therapy provides further benefits in...” NCT03192579 ↗ “Overall, treatment data in MDD support a role for EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in combination or EPA as the omega-3 fatty acid intervention.” NCT00825994 ↗ “Eicosapentaenoic acid (EPA):Docosahexaenoic acid (DHA)\[360 mg EPA and 240 DHA in each capsule\] 6 capsules-3 capsules by mouth 2 x per day x 48 weeks” NCT00323414 ↗ “The primary objective is to evaluate the efficacy of an enteric-coated, eicosapentaenoic acid-concentrated fish oil in the treatment of social phobia.” NCT00485615 ↗ “The omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) has anticolorectal cancer activity in vitro and in preclinical models.” PMID 20348368 ↗ Mar 2010 “Subjects received 2.2g of eicosapentaenoic acid (EPA) and 1.2g of docosahexaenoic acid (DHA) daily for the duration of the study.” NCT03101540 ↗ “eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.” NCT03657758 ↗ “Subjects received 2.2g of eicosapentaenoic acid (EPA) and 1.2g docosahexaenoic daily for the duration of the study” NCT03101527 ↗ “Participants will take 3.9g/day of Eicosapentaenoic acid and docosahexaenoic acid for 4 months” NCT02103842 ↗ “Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA” NCT00976872 ↗ |
| Known as | eicosapentaenoic acid (EPA) | “eicosapentaenoic acid (EPA)” NCT03101540 ↗1“eicosapentaenoic acid (EPA)” NCT03101527 ↗ |
| Known as | Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01078909 ↗ |
| Known as | EPA | “The purpose of this study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) in treating relapse, aggression, and...” NCT00312455 ↗15“Eicosapentaenoic acid (EPA) is another lipid-lowering therapyAccording to a recent study, the addition of highly purified EPA to statin therapy provides further benefits in...” NCT03192579 ↗ “Overall, treatment data in MDD support a role for EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in combination or EPA as the omega-3 fatty acid intervention.” NCT00825994 ↗ “Eicosapentaenoic acid (EPA):Docosahexaenoic acid (DHA)\[360 mg EPA and 240 DHA in each capsule\] 6 capsules-3 capsules by mouth 2 x per day x 48 weeks” NCT00323414 ↗ “The omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) has anticolorectal cancer activity in vitro and in preclinical models.” PMID 20348368 ↗ Mar 2010 “eicosapentaenoic acid(EPA) and rosuvastatin therapy improve lipid index in patients compared with rosuvastatin alone therapy.” NCT03657758 ↗ “Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found in oily fish.” NCT01070355 ↗ “Each pill contained 542mg of eicosapentaenoic acid, EPA, and 405mg of docosahexanoic acid, DHA” NCT00976872 ↗ “Omega 3 : 1380 mg EicosaPentaenoic Acid (EPA) + 1140 mg DocosaHexaenoic Acid (DHA) per day” NCT05796401 ↗ “Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) are the most common n-3 PUFA.” NCT03634644 ↗ “eicosapentaenoic acid (EPA), one of the omega-3 fatty acids found in fish oils.” PMID 31163106 ↗ Jun 2019 |
| Known as | EPA-FFA | “The present study tested whether a novel, enteric-coated formulation of EPA, as the free fatty acid (EPA-FFA), has chemopreventative efficacy in patients with familial...” PMID 20348368 ↗ Mar 20101“Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg gastro-resistant capsules 2g daily (two capsules twice daily).” NCT04335032 ↗ |
| Known as | Epadel | “Epadel, Eicosapentaenoic acid” NCT00692718 ↗ |
| Known as | EPADEL CAPSULES 300 | “Icosapent (EPADEL CAPSULES 300) capsules.” NCT03693131 ↗ |
| Known as | ethyl-eicosapentaenoic acid | “the omega-3 fatty acid, ethyl-eicosapentaenoic acid (EPA) to usual treatment” NCT00114595 ↗ |
| Known as | Icosapent | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03693131 ↗ |
| Known as | MND-2119 | “MND-2119 is a new formulation of Icosapent.” NCT03693131 ↗1“Icosapent (MND-2119) capsules.” NCT04221217 ↗ |
| Known as | O3mega+Joy | “Subjects meeting criteria for Social Anxiety Disorder, will receive enteric-coated, eicosapentaenoic acid-concentrated fish oil (O3mega+Joy) for 12 weeks of treatment for social phobia.” NCT00485615 ↗ |
| Modality | Small molecule | “omega-3 polyunsaturated fatty acid” NCT00114595 ↗ |
| Route | Oral | “encapsulated ethyl-EPA supplement 2 g/day (2X500 mg capsules twice daily)” NCT00114595 ↗ |
| Target | PCSK9 | “This study will test the hypothesis that EPA and DHA may differ in their LDL-C lowering ability because of differences in how they modulate plasma PCSK9 levels, which is a...” NCT02514070 ↗ |