Drugs / Gemfibrozil
Gemfibrozil
also known as
CI-719 · Emfib · Gemfibrozilo · Lopid · Lopid (Trademark) · Lopid-SR · NSC-757024 · PLX-200
Small molecule targets CYP2C8, PPARA via inhibition / activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOPID | — | 1989-01-17 | fda.gov ↗ |
| Approved | US (FDA) | LOPID | — | 1981-12-21 | fda.gov ↗ |
Trials 32 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02045056 | May 2014 → Jun 2018 | Alzheimer disease | Gregory Jicha, 323-5550 | Completed | No outcome recorded |
| Phase 124 trials | ||||||
| Phase 1 | NCT06809608 | Feb → Jun 2025 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT06392659 | May → Jul 2024 | — | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1 | NCT05959447 | Jul → Oct 2023 | — | Bellus Health Inc. - a GSK company | Completed | No outcome recorded |
| Phase 1 | NCT05932303 | Jul → Oct 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05868356 | Jun → Jul 2023 | — | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04956627 | Jul 2021 → Apr 2022 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05069870 | Jun → Nov 2021 | — | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT06064539 | May → Jul 2020 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04008186 | Jun → Aug 2019 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT03723395 | Sep → Dec 2018 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03624959 | Jun → Aug 2018 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02770222 | Jun → Jul 2016 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02230033 | Sep → Dec 2014 | — | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01836198 | May → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01736254 | Dec 2012 → Feb 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01340846 | Sep → Nov 2012 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01797198 | Apr → Jun 2012 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01913379 | Aug → Dec 2011 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01376232 | Nov → Dec 2010 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01083212 | Mar → Jun 2010 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00966966 | Sep → Dec 2009 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00566865 | Nov → Dec 2007 | type 2 diabetes mellitus | Elixir Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00108511 | Oct 2004 → Sep 2007 | hypertriglyceridemia | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 1 | NCT00039663 | May 2002 → Oct 2005 | HIV infectious disease | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03539432 | May → Dec 2018 | alcohol-related disorders | The Mind Research Network | Terminated | No outcome recorded |
| Phase 2 | NCT02638597 | Feb 2015 → Dec 2016 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01876810 | Feb 2014 → Feb 2016 | nicotine dependence | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 2 | NCT00000461 | Dec 1986 → Nov 1992 | coronary artery disorder, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04637282 | Nov → Dec 2026 expected | juvenile neuronal ceroid lipofuscinosis | Polaryx Therapeutics, Inc. | Not yet recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01385020 | Jul 2011 | — | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00243672 | Oct 2005 → Oct 2007 | atherosclerosis | University Hospital Muenster | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01301742 Comparator | Feb → May 2011 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05931484 Comparator | Nov 2027 → Nov 2028 expected | Parkinson disease | Forest Hills Lab | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00283335 Comparator | Jun 1991 → Sep 1998 | coronary artery disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01974544 Background | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| — | NCT00474201 Comparator | May 2007 → Jul 2008 | — | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gemfibrozil | “oral adagrasib 200 mg BID and gemfibrozil 600 mg BID for 10 days (Days 9 to 18), with no evening dose of adagrasib or gemfibrozil on Day 18.” NCT05868356 ↗34 |
| Known as | CI-719 | ChEMBL registry synonym — accepted as the source's own label CHEMBL457 ↗ |
| Known as | Emfib | ChEMBL registry synonym — accepted as the source's own label CHEMBL457 ↗ |
| Known as | Gemfibrozilo | “Gemfibrozilo or fenofibrate once daily can be used for isolated hypertriglyceridaemia” NCT01974544 ↗ |
| Known as | Lopid | ChEMBL registry synonym — accepted as the source's own label CHEMBL457 ↗ |
| Known as | Lopid (Trademark) | “the lipid-regulating drug gemfibrozil (Lopid (Trademark))” NCT00474201 ↗ |
| Known as | Lopid-SR | “1200 mg slow-release gemfibrozil (Lopid-SR) once per day” NCT00283335 ↗ |
| Known as | NSC-757024 | ChEMBL registry synonym — accepted as the source's own label CHEMBL457 ↗ |
| Known as | PLX-200 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04637282 ↗ |
| Action | Activate | “Peroxisome proliferator-activated receptor alpha agonist” CHEMBL457 ↗ |
| Action | Inhibit | “gemfibrozil (an organic anion-transporting polypeptide 1B1 [OATP1B1]/1B3 and organic anion transporter 3 [OAT3] inhibitor)” PMID 24491572 ↗ Feb 2014 |
| Modality | Small molecule | “Gemfibrozil is a fibric acid derivative (fibrate).” NCT01385020 ↗ |
| Route | Oral | “a single, 600 mg oral dose” NCT00474201 ↗ |
| Target | CYP2C8 | “a strong CYP2C8 inhibitor” PMID 28715853 ↗ Aug 2017 |
| Target | PPARA | “Peroxisome proliferator-activated receptor alpha agonist” CHEMBL457 ↗ |