Fenofibrate
Small molecule targets PPARA via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Pravafenix | — | 2011-04-14 | europa.eu ↗ |
| Label expansion | US (FDA) | ANTARA (MICRONIZED) | — | 2005-10-21 | fda.gov ↗ |
| Label expansion | US (FDA) | TRICOR (MICRONIZED) | — | 2000-04-24 | fda.gov ↗ |
| Approved | US (FDA) | TRICOR (MICRONIZED) | — | 1993-12-31 | fda.gov ↗ |
Trials 122 · started per year
Also used as a comparator or background therapy in 53 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06796660 Background | Sep 2025 → Dec 2027 expected | chronic kidney disease | Liu Zhanghong | Not yet recruiting | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT06155331 Comparator | Dec 2023 → Jan 2025 | female breast carcinoma | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT05781698 Comparator | Mar 2023 → Oct 2024 | inflammatory bowel disease | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT03515213 Comparator | Apr 2017 → Aug 2021 | Huntington disease | University of California, Irvine | Completed | No outcome recorded |
| Phase 2 | NCT02890992 Background | Sep 2016 → Sep 2018 | familial hypercholesterolemia | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT02354976 Comparator | Sep 2015 → May 2016 | NAFLD1, hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02158273 Comparator | May 2014 → Apr 2016 | alcohol dependence | The Scripps Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01594983 Comparator | Jun 2012 → Jul 2013 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01539616 Comparator | Nov 2011 → Jun 2012 | hyperlipidemia, hypertriglyceridemia | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 2 | NCT01141296 Comparator | Apr 2011 → ? | primary biliary cholangitis | University of Miami | Withdrawn | No outcome recorded |
| Phase 2 | NCT00559962 Comparator | Oct 2007 → Oct 2008 | hyperlipidemia | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00813527 Comparator | Feb 2006 → Jan 2007 | hyperlipidemia | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT00400231 Comparator | Aug 2005 → Dec 2007 | metabolic syndrome X | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00169559 Comparator | Nov 2003 → Apr 2005 | hyperlipidemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00703690 Comparator | Jan 2002 → Dec 2003 | metabolic syndrome X | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05753267 Comparator | Feb 2023 → Sep 2025 | inflammatory bowel disease | Tanta University | Completed | No outcome recorded |
| Phase 2/3 | NCT02452255 Comparator | Nov 2015 → Dec 2018 | — | The University of Texas Medical Branch, Galveston | Terminated | No outcome recorded |
| Phase 2/3 | NCT00732485 Comparator | Aug 2008 → Dec 2012 | — | The University of Texas Medical Branch, Galveston | Withdrawn | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT04998981 Comparator | Sep 2021 → Feb 2023 | hyperlipidemia | Kowa Company, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03510715 Background | Aug 2018 → Feb 2020 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03510884 Background | May 2018 → Jan 2021 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| 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 |
| Phase 3 | NCT02584504 Background | Nov 2015 → Apr 2017 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02023879 Background | Dec 2013 → Oct 2014 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01878227 Comparator | Jul 2010 → May 2011 | hyperlipoproteinemia | Zhejiang University | Completed | No outcome recorded |
| Phase 3 | NCT00251680 Comparator | Oct 2005 → May 2007 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT07025005 Comparator | Aug 2025 → Jun 2026 overdue | peripheral neuropathy, plasma cell myeloma | Tanta University | Recruiting | No outcome recorded |
| Phase 4 | NCT04140201 Comparator | Feb → Jun 2020 | diabetic retinopathy | Alaa Hassan ElBaz | Unknown | No outcome recorded |
| Phase 4 | NCT02984982 Background | Nov 2016 → Jul 2018 | acute coronary syndrome, hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02642159 Comparator | Mar 2016 → Mar 2017 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT03615534 Comparator | Oct 2014 → Jun 2015 | hypertriglyceridemia 2, obesity disorder | Lewai Sharki Abdulaziz, MSc PhD | Completed | No outcome recorded |
| Phase 4 | NCT02886299 Comparator | Oct 2013 → Jan 2016 | — | Cairo University | Completed | No outcome recorded |
| Phase 4 | NCT01574131 Comparator | May 2012 → Feb 2016 | — | The University of Texas Medical Branch, Galveston | Terminated | No outcome recorded |
| Phase 4 | NCT01666041 Comparator | Jan 2012 → Feb 2013 | hypertriglyceridemia | Gachon University Gil Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01003847 Comparator | Nov 2009 → Sep 2010 | hypertriglyceridemia | Gachon University Gil Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01010516 Comparator | Oct 2009 → Dec 2011 | hyperlipidemia | University of Ioannina | Unknown | No outcome recorded |
| Phase 4 | NCT00872599 Comparator | Sep 2009 → Jan 2012 | hypertensive disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 4 | NCT00923676 Comparator | Apr 2008 → Oct 2015 | hyperlipidemia, sexual disorder | University of Campania Luigi Vanvitelli | Unknown | No outcome recorded |
| Phase 4 | NCT00552747 Comparator | Oct 2007 → Mar 2010 | coronary artery disorder, hyperlipidemia | National Heart Institute, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT00246636 Background | Oct 2005 → Feb 2007 | hypertriglyceridemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00809068 Comparator | Aug 2005 → Aug 2009 | — | Keogh Institute for Medical Research | Completed | No outcome recorded |
| Phase 4 | NCT00754039 Background | Feb → Sep 2003 | familial hyperlipidemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 4 | NCT00632840 Comparator | Jun 2001 → Dec 2002 | cardiovascular disorder, hypertriglyceridemia, lip disorder, obesity disorder | The University of Western Australia | Completed | No outcome recorded |
| Phase 4 | NCT00304993 Background | Jan 2001 → Feb 2005 | metabolic syndrome X | Foundation Research, Florida | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT05813145 Comparator | Jan 2023 → Aug 2024 | breast cancer | Damanhour University | Completed | No outcome recorded |
| — | NCT04418180 Comparator | Jun 2016 → Dec 2018 | congenital nonhemolytic jaundice | Mansoura University | Completed | No outcome recorded |
| — | NCT01974544 Background | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| — | NCT01101204 Comparator | Jul → Oct 2012 | hyperlipidemia, type 2 diabetes mellitus | Medical University of Silesia | Unknown | No outcome recorded |
| — | NCT00794963 Background | Nov 2008 → May 2010 | metabolic syndrome X | Northwell Health | Terminated | No outcome recorded |
| — | NCT00644592 Comparator | Mar 2008 → Aug 2009 | — | University of Florida | Terminated | No outcome recorded |
| — | NCT00491400 Comparator | Sep 2005 → Dec 2008 | diabetes mellitus, metabolic syndrome X | Boston University | Terminated | No outcome recorded |
| — | NCT00186537 Comparator | Sep 2003 → Sep 2008 | hypertriglyceridemia | Stanford University | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2005-05-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva's Fenofibrate Product Receives Final Approval; Seeks Three Times Its Lost Profits In Antitrust Lawsuit Against Abbott tevapharm.com ↗ |
| 2004-03-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Fenofibrate Tablets, 54 Mg, 160 Mg tevapharm.com ↗ |
| 2002-09-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Fenofibrate Capsules (micronized), 67mg. will Have 180 Days of Marketing Exclusivity tevapharm.com ↗ |
| 2002-04-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Fenofibrate Capsules tevapharm.com ↗ |
| 2002-03-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Resolution of Patent Litigation for Fenofibrate Capsules tevapharm.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 180 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fenofibrate | “The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia” NCT00664859 ↗172“A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers” NCT02250976 ↗ “We evaluated the safety and efficacy of icosapent ethyl (Vascepa) and fenofibrate to mitigate triglyceride elevations in patients with NASH treated with CILO and FIR.” PMID 34999207 ↗ Jan 2022 “40mg atorvastatin combined with 100mg fenofibrate in a tablet for once daily treatment of dyslipidemia and mixed dyslipidemia” NCT00504829 ↗ “Lipid Control: Medications such as atorvastatin calcium tablets (20 mg qd) or fenofibrate capsules (0.2 g qd) can be used.” NCT06796660 ↗ “Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)” NCT01353404 ↗ “Gemfibrozilo or fenofibrate once daily can be used for isolated hypertriglyceridaemia” NCT01974544 ↗ “Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg” NCT03618797 ↗ “Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.” NCT02584504 ↗ “rosuvastatin 10 mg plus fenofibrate 160 mg or rosuvastatin 10 mg.” PMID 22269152 ↗ Jan 2012 “Fenofibrate; 145 mg daily (1/day); oral administration; 10 days” NCT04661930 ↗ “Ezetimibe or Fenofibrate at stable dose as background therapy.” NCT02023879 ↗ “Subjects will receive fenofibrate 54mg daily.” NCT01280604 ↗ “fenofibrate 160 mg po for 16 weeks” NCT01122355 ↗ “267mg of Fenofibrate” NCT01099176 ↗ |
| Known as | Antara | “Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]” NCT00891293 ↗1“Antara (fenofibrate) + Lovaza” NCT00246636 ↗ |
| Known as | FEN | “Whole body and liver insulin sensitivity were assessed with a hyperinsulinemic-euglycemic clamp, and insulin signaling and mitochondrial function were measured in muscle...” PMID 17245174 ↗ Feb 2007 |
| Known as | FENO | “receiving placebo (PBO), fenofibrate (FENO), ezetimibe plus FENO (EZE+FENO), or EZE/simvastatin plus FENO (EZE/SIMVA+FENO) for 12 weeks.” PMID 22087637 ↗ Nov 20111“Participants will receive fenofibrate (FENO) 48 mg tablet orally once daily for 2 weeks in the pretreatment phase” NCT02781584 ↗ |
| Known as | fenofibrate (Tricor) | “fenofibrate (Tricor)” NCT00000620 ↗ |
| Known as | Lipanthyl | “Fenofibrate (Lipanthyl®) 200mg capsule will be administered orally with breakfast once daily” NCT02314533 ↗ |
| Known as | Lipidil Supra | “Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)” NCT01353404 ↗1“Lipitor(Atorvastatin Calcium Trihydrate 20mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)” NCT03346187 ↗ |
| Known as | Lipilfen | “To evaluate the comparative pharmacokinetics and safety of fixed-dose combination versus coadministration of Lipilfen cap.160mg(micronized fenofibrate160mg) and Livalo tab....” NCT02250976 ↗ |
| Known as | NanoCrystal(R) | “OBJECTIVE: To assess the efficacy and safety of coadministration of fenofibrate (NanoCrystal(R)) and ezetimibe in patients with type IIb dyslipidemia and the metabolic syndrome...” PMID 19331437 ↗ 2009 |
| Known as | Phenofibrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05909800 ↗ |
| Known as | SYO-0805 | “Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)” NCT01353404 ↗ |
| Known as | Tricor | “Tricor® is the brand name for prescription fenofibrate pills.” NCT01048502 ↗ |
| Known as | Trolip | “Eligible subjects will be prescribed the study drug, fenofibrate (Trolip®).” NCT03869931 ↗ |
| Action | Activate | “PPAR-alpha agonist” NCT00252499 ↗ |
| Modality | Small molecule | “Fenofibrate is a fibric acid postulated to regulate immune response and cell proliferation.” PMID 21083674 ↗ Nov 2010 |
| Route | Oral | “micronized fenofibrate 200 mg 1 po qd” NCT00252499 ↗ |
| Target | PPARA | “PPAR-alpha agonist” NCT00252499 ↗ |