Drugs / Fenofibrate
Fenofibrate
also known as
TRICOR · Antara · FENO · Lipidil supra · FEN · fenofibrate (Tricor) · Lipanthyl · Lipilfen · +3 more
Small molecule targets PPARA via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hypertriglyceridemia 2 1 milestone | |||||
| Filed | US (FDA) | Tricor | hypertriglyceridemia 2 | 2002-12-02 | “FDA) has accepted the Company's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Tricor® (Fenofibrate) 160 mg Tablets.” amneal.com ↗ “IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for Fenofibrate in July 2000” amneal.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| 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 120 · started per year
today
US approved 1993
EU approved 2011
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07104201 | Mar 2025 → Mar 2035 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 0 | NCT06591455 | Sep 2024 → Aug 2025 | primary biliary cholangitis | Han Ying | Completed | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT06191133 | Nov 2024 → Jun 2026 overdue | cervical cancer, cervical intraepithelial neoplasia | Lindsay Ferguson, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT03346187 | May 2017 | hyperlipidemia | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT02891408 | Sep 2016 → May 2019 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02250976 | Sep → Oct 2014 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02066207 | Mar → Apr 2014 | familial hypercholesterolemia, hyperlipidemia, combined, 2 | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT01767610 | Jan → Mar 2013 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01723735 | Nov 2012 → Jul 2013 | hyperlipoproteinemia | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01353404 | Jun → Aug 2011 | hyperlipidemia | Samyang Biopharmaceuticals Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01148004 | May 2010 → Jul 2013 | HIV infectious disease, hypertriglyceridemia 2 | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT01109758 | Mar → Jul 2008 | — | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00376285 | Nov 2006 → ? | obesity disorder | Pfizer | Withdrawn | No outcome recorded |
| Phase 1 | NCT00543647 | Aug 2002 → Mar 2003 | — | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT02965911 | Jan 2016 → Sep 2021 | primary biliary cholangitis | Beijing 302 Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01142323 | Oct 2010 → Dec 2012 | primary sclerosing cholangitis | University of Miami | Terminated | Met primary |
| Phase 219 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07572552 | May 2026 → Apr 2027 expected | infectious disease with sepsis | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06905054 | Apr 2025 → Mar 2028 expected | primary sclerosing cholangitis | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT05514119 | Aug 2022 → Jun 2024 | — | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04907084 | Apr 2022 → Sep 2024 | macular telangiectasia type 2 | The Lowy Medical Research Institute Limited | Completed | No outcome recorded |
| Phase 2 | NCT04929379 | Jan 2022 → May 2025 overdue | diabetic kidney disease | Alessandro Doria | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06623539 | Dec 2020 → Jun 2025 overdue | NAFLD1 | Yokohama City University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02781584 | Jun 2016 → Dec 2020 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01965834 | Nov 2012 → Mar 2016 | plasma cell myeloma | University of Miami | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01426438 | Nov 2011 → Oct 2013 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | Missed primary |
| Phase 2 | NCT00575042 | Aug 2007 → Aug 2009 | primary biliary cholangitis | University of Florida | Completed | Met primary |
| Phase 2 | NCT00504829 | Jul 2007 → Feb 2008 | hyperlipidemia | Veloxis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00359281 | Mar 2006 → Nov 2007 | — | Aegerion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00816829 | Sep 2005 → Jan 2008 | hyperlipidemia, obesity disorder, sleep apnea syndrome | Solvay Pharmaceuticals | Terminated | Mixed Stop: Enrollment |
| Phase 2 | NCT00357500 | Jan 2005 → Feb 2013 | central nervous system cancer, childhood malignant neoplasm, leukemia, lymphoma +2 | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00349635 | Oct 2004 → ? | obesity disorder | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00361751 | May 2003 → May 2005 | — | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00703482 | May 2003 → Sep 2004 | — | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00703755 | Mar 2003 → Jun 2004 | metabolic syndrome X | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00076518 | ? → Sep 2005 | HIV infectious disease, hypertriglyceridemia | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/38 trials | ||||||
| Phase 2/3 | NCT06346743 | Apr → Jul 2024 | hyperbilirubinemia | Muhammad Zark | Unknown | No outcome recorded |
| Phase 2/3 | NCT06174402 | Aug 2023 → Jul 2026 overdue | primary biliary cholangitis | Han Ying | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05749822 | Feb 2023 → Dec 2027 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06365424 | Apr 2017 → Apr 2027 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02455336 | May 2015 → Aug 2018 | hyperlipidemia, spinal cord injury | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2/3 | NCT00664859 | Oct 2007 → Feb 2009 | hyperlipidemia | Veloxis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/3 | NCT00362765 | Oct 2006 → Jul 2007 | hyperlipidemia, type 2 diabetes mellitus | Solvay Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT00349128 | Jan 2004 → ? | hyperlipidemia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 335 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT07296458 | Dec 2025 → Dec 2028 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT06755541 | Jan 2024 → Dec 2035 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT06755151 | Jan 2024 → Dec 2035 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT05751967 | Feb 2023 → Dec 2027 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT04882293 | Feb → May 2022 | type 2 diabetes mellitus | Laboratorios Silanes S.A. de C.V. | Unknown | No outcome recorded |
| Phase 3 | NCT04661358 | Mar 2021 → Dec 2029 expected | diabetic retinopathy | Jaeb Center for Health Research | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04661930 | Jan 2021 → May 2022 | COVID-19 | Yaakov Nahmias | Unknown | No outcome recorded |
| Phase 3 | NCT03869931 | Mar 2019 → Apr 2021 | diabetes mellitus, diabetic kidney disease | Singapore General Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01320345 | Nov 2016 → Aug 2026 overdue | diabetic kidney disease, diabetic retinopathy, type 1 diabetes mellitus | University of Sydney | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02823353 | Apr 2016 → May 2022 | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Completed | Met primary |
| Phase 3 | NCT02823366 | Jan 2016 → Dec 2023 | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Unknown | No outcome recorded |
| Phase 3 | NCT03618797 | Nov 2015 → Jan 2018 | hyperlipidemia, combined, 2 | Hanlim Pharm. Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT02262143 | Nov 2014 → Oct 2016 | hyperlipidemia, combined, 2 | IlDong Pharmaceutical Co Ltd | Completed | No outcome recorded |
| Phase 3 | NCT02166593 | May 2014 → Jan 2018 | hyperlipidemia, combined, 2 | Yooyoung Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01956201 | Dec 2013 → Aug 2016 | hyperlipidemia, combined, 2 | Chong Kun Dang Pharmaceutical | Unknown | No outcome recorded |
| Phase 3 | NCT01674712 | Jun 2012 → Oct 2013 | hyperlipidemia | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00459745 | Apr 2007 → Apr 2008 | hyperlipidemia, combined, 2 | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT00490178 | Mar 2007 → ? | hyperlipidemia, type 2 diabetes mellitus | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00362934 | Oct 2006 → Aug 2008 | hyperlipidemia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00362323 | Oct 2006 → Aug 2008 | hyperlipidemia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00362206 | Sep 2006 → Sep 2008 | hyperlipidemia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00361868 | Jun 2006 → Dec 2007 | glucose metabolism disease, hyperlipidemia | Solvay Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00352183 | Jan 2006 → Aug 2008 | cardiovascular disorder | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00349375 | Nov 2005 → Sep 2008 | hyperlipidemia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00348725 | Apr 2005 → ? | hyperlipidemia | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00139061 | Mar 2005 → May 2006 | hyperlipidemia | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00145431 | Mar 2005 → Dec 2006 | hyperlipoproteinemia type 3 | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT00261352 | Mar 2005 → Dec 2006 | type 2 diabetes mellitus | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT00349284 | Jan 2005 → ? | hyperlipidemia, combined, 2 | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00195793 | Aug 2004 → ? | hyperlipidemia | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00542178 | Oct 2003 → Dec 2009 | diabetic retinopathy | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Mixed |
| Phase 3 | NCT00092573 | Apr 2003 → Nov 2004 | hyperlipidemia, hypertriglyceridemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00092560 | Dec 2002 → Dec 2003 | hyperlipidemia, hypertriglyceridemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00000620 | Sep 1999 → Jun 2009 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| Phase 3 | NCT00006412 | ? → May 2003 | HIV infectious disease, lipodystrophy | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 419 trials · 2 met primary | ||||||
| Phase 4 | NCT06451900 | Jul → Nov 2023 | congenital nonhemolytic jaundice | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT05498090 | Nov 2022 → Jun 2025 | Klinefelter syndrome | University of Colorado, Denver | Unknown | No outcome recorded |
| Phase 4 | NCT04528212 | Nov 2020 → Nov 2021 | type 2 diabetes mellitus | Rehab Werida | Completed | No outcome recorded |
| Phase 4 | NCT03829514 | Feb 2019 → Mar 2020 | type 2 diabetes mellitus | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT03874260 | Jul 2018 → Jan 2020 | hyperlipidemia | Daewon Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT03439345 | Jul 2018 → Nov 2023 | diabetic retinopathy | University of Oxford | Completed | Met primary |
| Phase 4 | NCT02314533 | Dec 2014 → Dec 2016 | proteinuria | Beijing Chao Yang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02232360 | Jan 2014 → Dec 2020 | coronary artery disorder | Gachon University Gil Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02015988 | Jan 2014 → Sep 2016 | acute coronary syndrome, hypertriglyceridemia, type 2 diabetes mellitus | Dnipropetrovsk State Medical Academy | Unknown | No outcome recorded |
| Phase 4 | NCT01927315 | Aug 2013 → Oct 2019 | diabetes mellitus, diabetic retinopathy | University of Padova | Completed | Met primary |
| Phase 4 | NCT01462877 | Oct 2011 → Feb 2014 | cardiovascular disorder, hyperlipidemia, hypertriglyceridemia | Abbott | Completed | No outcome recorded |
| Phase 4 | NCT01414803 | Mar 2009 → Apr 2011 | hyperlipidemia | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00843661 | Mar 2009 → Dec 2011 | HIV infectious disease, hyperlipidemia | Ospedale di Circolo - Fondazione Macchi | Unknown | No outcome recorded |
| Phase 4 | NCT02153879 | Feb 2009 → Dec 2011 | hyperlipidemia, type 2 diabetes mellitus | Institut Investigacio Sanitaria Pere Virgili | Completed | No outcome recorded |
| Phase 4 | NCT01122355 | Feb 2009 → Jan 2010 | metabolic disease | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00819910 | Sep 2008 → May 2010 | hypertriglyceridemia | Ahmad Slim | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00385658 | Aug 2006 → Mar 2007 | hyperlipidemia | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00891293 | Mar 2006 → May 2008 | hypertriglyceridemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00745407 | Jan 2005 → Aug 2008 | hypertriglyceridemia | Gachon University Gil Medical Center | Completed | No outcome recorded |
| Phase not applicable21 trials · 1 met primary · 2 missed | ||||||
| — | NCT06293417 | Mar 2024 → Feb 2027 expected | hyperlipidemia, type 2 diabetes mellitus | Korea University Anam Hospital | Recruiting | No outcome recorded |
| — | NCT05542147 | Jul 2022 → Nov 2024 | cardiovascular disorder, type 2 diabetes mellitus | Mario Luca Morieri | Completed | No outcome recorded |
| — | NCT04868019 | Sep 2021 → Feb 2022 | hyperbilirubinemia | Shaheed Zulfiqar Ali Bhutto Medical University | Unknown | No outcome recorded |
| — | NCT05256758 | May 2019 → Mar 2022 | aortic valve stenosis | University of Oxford | Unknown | No outcome recorded |
| — | NCT03557983 | Jun 2018 → Apr 2020 | radiodermatitis | Second Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| — | NCT04885153 | Nov 2016 → Jul 2017 | diabetes mellitus, diabetic retinopathy, hyperlipidemia | Indonesia University | Completed | No outcome recorded |
| — | NCT01752842 | Mar 2013 → Feb 2018 | type 2 diabetes mellitus | Washington University School of Medicine | Completed | Missed primary |
| — | NCT01280604 | Oct 2010 → Jan 2013 | hyperlipidemia | Kaiser Permanente | Completed | No outcome recorded |
| — | NCT01048502 | Jan 2010 → May 2011 | cardiovascular disorder | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT00884819 | Dec 2008 → Feb 2015 | polycystic ovary syndrome | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01099176 | May 2008 → May 2009 | hyperlipidemia, prediabetes syndrome | Medical University of Silesia | Completed | No outcome recorded |
| — | NCT00470262 | Jan 2007 → Dec 2012 | metabolic syndrome X, prediabetes syndrome | VA Office of Research and Development | Completed | No outcome recorded |
| — | NCT00458055 | Nov 2006 → Sep 2007 | coronary atherosclerosis, hypoalphalipoproteinemia, inborn errors of metabolism | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| — | NCT01289639 | Oct 2005 → Aug 2013 | fatty liver disease | VA Office of Research and Development | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00252499 | Oct 2005 → Aug 2010 | fatty liver disease | US Department of Veterans Affairs | Terminated | No outcome recorded |
| — | NCT00627653 | Oct 2005 → Dec 2009 | cardiovascular disorder | National Institute on Aging (NIA) | Unknown | No outcome recorded |
| — | NCT00262964 | Oct 2004 → Dec 2008 | NAFLD1 | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00246376 | Jan 2004 → Sep 2009 | HIV infectious disease, atherosclerosis, heart disorder, hyperlipidemia +1 | Baylor College of Medicine | Completed | Met primary |
| — | NCT00309712 | Aug 2002 → Sep 2006 | hyperlipidemia, combined, 2, type 2 diabetes mellitus | Intermountain Health Care, Inc. | Completed | Missed primary |
| — | NCT00422396 | Jan 2001 → Apr 2002 | hypertriglyceridemia | University of Michigan | Completed | No outcome recorded |
| — | NCT00483210 | — | — | University of Arkansas | Withdrawn | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT00965315 | — | cardiovascular disorder | National Taiwan University Hospital | Available | No outcome recorded |
| — | NCT00934258 | — | hyperlipidemia | National Taiwan University Hospital | Available | No outcome recorded |
| Comparator or background therapy53 trials | ||||||
| Phase 0 | NCT06796660 Background | Sep 2025 → Dec 2027 expected | chronic kidney disease | Liu Zhanghong | Not yet recruiting | No outcome recorded |
| 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 | Missed primary |
| 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 Stop: Business |
| 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 2/3 | 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 3 | NCT04998981 Comparator | Sep 2021 → Feb 2023 | hyperlipidemia | Kowa Company, Ltd. | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02023879 Background | Dec 2013 → Oct 2014 | hyperlipidemia | Sanofi | Completed | Met primary |
| 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 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 | Missed primary |
| Phase 4 | NCT02642159 Comparator | Mar 2016 → Mar 2017 | hyperlipidemia | Sanofi | Completed | Met primary |
| 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 Stop: Business |
| 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 | Missed primary |
| 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 |
| — | 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 Stop: Enrollment |
| — | 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 Stop: Enrollment |
| — | NCT00186537 Comparator | Sep 2003 → Sep 2008 | hypertriglyceridemia | Stanford University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2021-06-21 | Gilead Sciences | Results Gilead to Present More Than 70 Abstracts From Diverse Liver Disease Programs At The International Liver Congress™ 2021 gilead.com ↗
Fenofibrate is safe and mitigates increases in serum triglycerides in NASH patients treated with the combination of the ACC inhibitor firsocostat and the FXR agonist cilofexor: A randomized trial |
| 2020-10-01 | Alembic Pharmaceuticals Ltd. | Regulatory 21st October, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Capsules USP, 67 mg, 134 mg and 200 mg. |
| 2019-11-08 | Gilead Sciences | Results Data Showing Potential for Machine Learning to Advance Understanding of Nonalcoholic Steatohepatitis (NASH) Presented at the Liver Meeting® 2019 gilead.com ↗
New Results Show Fenofibrate Mitigates Increases in Serum Triglycerides in NASH Patients Treated With Investigational Firsocostat |
| 2019-08-01 | Alembic Pharmaceuticals Ltd. | Regulatory 13th August, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP, 48 mg and 145 mg. |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
The addition of fenofibrate to a liver-targeted acetyl CoA carboxylase inhibitor reverses plasma TG increases and positively impacts efficacy (poster #0284) |
| 2011-07-25 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s ‘Lipilfen’ shows excellent improvement effect in dyslipidemia daewoong.co.kr ↗
The product has proved effective in increasing HDL-C and decreasing neutral fats and LDL-C with its fenofibrate medicine, which improves bio absorbable rate using micronized technology. |
| 2009-10-30 | Impax Laboratories, LLC | Regulatory Impax Laboratories Confirms Patent Challenge Relating to TRICOR(R) 48mg and 145mg Tablets amneal.com ↗
Impax filed its Abbreviated New Drug Application (“ANDA”) containing a Paragraph IV certification for a generic version of TRICOR® with the U.S. Food & Drug Administration (“FDA”). |
| 2005-05-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva's Fenofibrate Product Receives Final Approval; Seeks Three Times Its Lost Profits In Antitrust Lawsuit Against Abbott tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Fenofibrate Tablets, 54 mg and 160 mg. |
| 2004-03-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Fenofibrate Tablets, 54 Mg, 160 Mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Fenofibrate Tablets, 54 mg and 160 mg. |
| 2004-03-08 | Impax Laboratories, LLC | Regulatory IMPAX Receives Tentative FDA Approval for Generic Version of Tricor Tablets; Fourth ANDA Approval of 2004 amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for its generic version of Tricor(R) (Fenofibrate) Tablets. |
| 2003-10-28 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Fenofibrate Capsules ANDA; Eighth ANDA Approval of 2003 for IMPAX amneal.com ↗
IMPAX Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Fenofibrate Capsules, Micronized. |
| 2002-12-02 | Impax Laboratories, LLC | Regulatory IMPAX ANDA Filing for Generic Version of Tricor Tablets Accepted by FDA amneal.com ↗
FDA's acceptance of the IMPAX ANDA for filing means that the Agency has made a threshold determination that the application is sufficiently complete to permit a substantive review. |
| 2002-09-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Fenofibrate Capsules (micronized), 67mg. will Have 180 Days of Marketing Exclusivity tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted final approval for the company's ANDA for Fenofibrate Capsules (Micronized), 67 mg. |
| 2002-04-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Fenofibrate Capsules tevapharm.com ↗ |
| 2002-02-21 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Tentative Approval of Fenofibrate ANDA amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Tricor® (Fenofibrate Capsules), Micronized. |
All press releases naming this drug 21 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 178 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 ↗ |
| 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 | 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 ↗ |