Drugs / Gemfibrozil
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 31
| 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 → May 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 · 1 missed | ||||||
| Phase 2 | NCT03539432 | May → Dec 2018 | alcohol-related disorders | The Mind Research Network | Terminated | No outcome recorded Stop: Business |
| 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 | Missed primary |
| Phase 2 | NCT00000461 | Dec 1986 → Nov 1992 | coronary artery disorder, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 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 |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT01301742 Comparator | Feb → May 2011 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT05931484 Comparator | Nov 2027 → Nov 2028 expected | Parkinson disease | Forest Hills Lab | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT00283335 Comparator | Jun 1991 → Sep 1998 | coronary artery disorder | VA Office of Research and Development | Completed | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-04-21 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Receives U.S. FDA Fast Track Designations for All Four Indications to be Evaluated in the SOTERIA Basket Trial polaryx.com ↗
Following the March 2026 grant of FTD to PLX-200 in treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis (LINCL/CLN2 disease), PLX-200 now holds FTD for all four prospective indications to be studied in the SOTERIA Phase 2 basket trial. |
| 2026-02-10 | Polaryx Therapeutics, Inc. | Results Polaryx Announces Key Pre-Clinical Data Related to SOTERIA at the 22nd Annual WORLDSymposium™ polaryx.com ↗
Most importantly, gemfibrozil restored motor functions and increased lifespan in GALC -/- mice. |
| 2021-09-02 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Receives FDA Orphan Drug Designation for PLX-200 to Treat Krabbe Disease polaryx.com ↗
Polaryx Therapeutics, Inc. ("Polaryx"), a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation for PLX-200 to treat Krabbe disease. |
| 2021-08-30 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Announces FDA Grants Orphan Drug Designation for PLX-200 in GM2 Gangliosidoses polaryx.com ↗
Polaryx Therapeutics, Inc. ("Polaryx"), a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation for PLX-200 to treat GM2 gangliosidoses. |
| 2020-08-20 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Receives FDA Fast Track Designation to PLX-200 for the Treatment of Patients With Juvenile Neuronal Ceroid Lipofuscinosis polaryx.com ↗
We are very excited about the FDA Fast Track Designation to PLX-200 for CLN3 treatment. |
| 2020-04-08 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Receives IND Approval From the FDA to Study PLX-200 Treatment for Patients With Juvenile Neuronal Ceroid Lipofuscinosis polaryx.com ↗
Polaryx Therapeutics, a biotech company developing patient-friendly, small molecule therapeutics for lysosomal storage disorders, announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients. |
| 2020-01-20 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Receives IND Approval for PLX-200 From the FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis polaryx.com ↗
Polaryx Therapeutics, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of LINCL patients with PLX-200. |
| 2019-12-23 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Submits Investigational New Drug Application to the U.S. FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis With PLX-200 polaryx.com ↗ |
| 2018-02-26 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Received Orphan Drug Designation From the European Medicines Agency (EMA) for the Treatment of All Neuronal Ceroid Lipofuscinosis With PLX-200 polaryx.com ↗
Granting PLX-200 the Orphan Drug Designation (ODD) for Neuronal Ceroid Lipofuscinosis from the European Medicines Agency (EMA) indicates that the EMA highly regarded the significant value of the PLX-200 program, especially its safety and many potential benefits to patients. |
| 2017-08-07 | Polaryx Therapeutics, Inc. | Regulatory Polaryx Therapeutics Receives Orphan Drug Designation From the U.S. FDA for PLX-200 for Rare Pediatric Disease polaryx.com ↗
Polaryx Therapeutics, Inc, a biotech company developing oral small molecule therapeutics for Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and for other forms of NCL, commonly known as Batten disease, has been granted Orphan Drug Designation from the U.S. FDA for PLX-200 to treat LINCL. |
All press releases naming this drug 11 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 39 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 ↗ |
| 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 ↗ |
| 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 ↗ |