fenofibrate
Trade name: fenoglide
Approved
Dec 31, 1993
Fenofibrate, sold under the brand name Tricor among others, is an oral medication of the fibrate class used to treat abnormal blood lipid levels. It is less commonly used compared to statins because it treats a different type of cholesterol abnormality to statins. While statins have strong evidence for reducing heart disease and death, there is evidence to suggest that fenofibrate also reduces the risk of heart disease and death. However, this seems only to apply to specific populations of people with elevated triglyceride levels and reduced high-density lipoprotein (HDL) cholesterol. Its use is recommended together with dietary changes. — Wikipedia
Clinical trial activity
220 trials · 193 clinical orgs · 49 marketing orgs
Earliest trial started Sep 1, 1999 (NCT00000620)
Timeline
1990s
2000s
- Jan 1, 2002
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Apr 9, 2002
Rhodes Pharmaceuticals, L.P. — Marketing Organization
- Oct 27, 2003
Impax Laboratories — Marketing Organization
- Nov 30, 2004
Lupin — NDA Secondary Org
- May 7, 2005
SkyePharma AG — NDA Secondary Org
- Oct 31, 2005
Sun Pharmaceuticals — Marketing Organization
- Dec 29, 2005
Mylan — Marketing Organization
- Jan 11, 2006
Cipher Pharmaceuticals Inc. — NDA Secondary Org
- Aug 10, 2007
Santarus — NDA Secondary Org
- Aug 10, 2007
Salix — NDA Secondary Org
- Aug 14, 2009
University of Pennsylvania — NDA Secondary Org
2010s
- Dec 23, 2011
Lupin — Marketing Organization
- Mar 1, 2012
Dr. Reddy's Laboratories — Marketing Organization
- Apr 5, 2012
Bausch Health Companies — Marketing Organization
- Oct 23, 2012
Rising Pharmaceuticals — Marketing Organization
- Jul 18, 2013
Anchen Pharmaceuticals, Inc — Marketing Organization
- Jul 18, 2013
Par Pharmaceuticals — Marketing Organization
- Jul 26, 2013
Apotex — Marketing Organization
- Oct 7, 2015
Actavis — Marketing Organization
- Oct 7, 2015
Allergan PLC (2015) — Marketing Organization
- May 5, 2016
Aurobindo Pharma — Marketing Organization
- Jul 12, 2016
Hetero Labs Ltd — Marketing Organization
- Dec 15, 2016
Cipla — Marketing Organization
- Mar 28, 2017
Invagen Pharms — Marketing Organization
- Apr 7, 2017
Glenmark Pharmaceuticals — Marketing Organization
- May 12, 2017
Alembic — Marketing Organization
- Nov 16, 2017
Reyoung Pharma Co Ltd — Marketing Organization
- Nov 16, 2017
Austarpharma — Marketing Organization
- Feb 9, 2018
Amneal Pharmaceuticals — Marketing Organization
- Apr 30, 2018
Amerigen Pharmaceuticals — Marketing Organization
- Apr 30, 2018
Ani Pharmaceuticals — Marketing Organization
- Jun 26, 2018
Torrent Pharmaceuticals Limited — Marketing Organization
- Jul 20, 2018
Ajanta Pharma Ltd — Marketing Organization
- Aug 17, 2018
Graviti Pharmaceuticals — Marketing Organization
- Aug 17, 2018
Adaptis Pharma — Marketing Organization
- Aug 28, 2018
Prinston Inc — Marketing Organization
- Feb 11, 2019
Orit Labs Llc — Marketing Organization
- Feb 11, 2019
Chartwell Pharmaceuticals — Marketing Organization
- Apr 19, 2019
Ingenus Pharmaceuticals — Marketing Organization
- Apr 19, 2019
Novast Labs — Marketing Organization
- Jul 5, 2019
TWi Biotechnology, Inc. — Marketing Organization
- Jul 5, 2019
ScinoPharm Taiwan — Marketing Organization
- Sep 6, 2019
Nuvo Research Inc. — Marketing Organization
- Sep 6, 2019
Appco Pharma — Marketing Organization
2020s
- Jun 12, 2020
MannKind Corp — Marketing Organization
- Jun 12, 2020
Mankind Pharma — Marketing Organization
- Jun 16, 2020
Micro Labs Ltd India — Marketing Organization
- Dec 23, 2020
Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization
- Sep 7, 2023
CREEKWOOD PHARMS — Marketing Organization
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 4
- Albuminuria · Phase 4
- Alcoholism · Phase 2
- Atherosclerosis · Phase 4
- Breast Neoplasms · Phase 4
- Burns · Phase 4
- Cervical Intraepithelial Neoplasia · Phase 1
- Cholangitis · Phase 3
- Cholangitis, Sclerosing · Phase 2
- Cholestasis · Phase 2
- Cholesterol, HDL · Phase 4
- Chylomicrons · Phase 2
- Coronary Artery Disease · Phase 3
- Coronary Disease · Phase 4
- COVID-19 · Phase 3
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 3
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Nephropathies · Phase 4
- Diabetic Retinopathy · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 1
- Drugs, Investigational · Phase 4
- Dyslipidemias · Phase 4
- Ependymoma · Phase 2
- Fenofibrate · Phase 1
- Genetic Diseases, Inborn · Phase 4
- Glucose Metabolism Disorders · Phase 3
- Glucuronosyltransferase · Phase 1
- Healthy Volunteers · Phase 2
- HIV · Phase 4
- HIV Infections · Phase 4
- Huntington Disease · Phase 2
- Hyperbilirubinemia · Phase 2/Phase 3
- Hyperlipidemia, Familial Combined · Phase 4
- Hyperlipidemias · Phase 4
- Hyperlipoproteinemias · Phase 3
- Hyperlipoproteinemia Type III · Phase 3
- Hypertension · Phase 4
- Hypertriglyceridemia · Phase 4
- Induced Pluripotent Stem Cells · Phase 2
- Inflammatory Bowel Diseases · Phase 2/Phase 3
- Insulin Resistance · Phase 4
- Jaundice, Neonatal · Phase 4
- Kidney Diseases · Phase 3
- Klinefelter Syndrome · Phase 4
- Leukemia · Phase 2
- Lipodystrophy · Phase 3
- Liver Cirrhosis, Biliary · Phase 3
- Liver Transplantation · Phase 2
- Lymphoma · Phase 2
- Macula Lutea · Phase 2
- Macular Edema · Phase 2
- Medulloblastoma · Phase 2
- Metabolic Syndrome · Phase 4
- Multiple Myeloma · Phase 4
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 2
- Neuroblastoma · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 2
- Obesity · Phase 4
- Overweight · Phase 2
- Peripheral Nervous System Diseases · Phase 4
- Pharmacokinetics · Phase 1
- Protease Inhibitors · Phase 1
- Respiratory Distress Syndrome · Phase 3
- Rhabdoid Tumor · Phase 2
- Sarcoma · Phase 2
- Sexual Dysfunction, Physiological · Phase 4
- Sleep Apnea Syndromes · Phase 2
- Spinal Cord Injuries · Phase 2/Phase 3
- Uterine Cervical Neoplasms · Phase 1
- Vascular Diseases · Phase 4
Mechanism of action
Approval history
- approvedDec 31, 1993
Chemistry & pharmacology
SMILES
CC(C)(Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1)C(=O)O- Mol. weight
- 318.76 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL981 ↗
- WikipediaFenofibrate ↗
- ChEMBLCHEMBL1201745 ↗
- NCATSU202363UOS ↗
- NCATSBGF9MN2HU1 ↗
- WikipediaFibrate ↗
- ChEMBLCHEMBL672 ↗
Also known as
- 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
- 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester
- 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester
- 2-(4-(4-chlorophenoxy)phenoxy)propanoic acid
- 2-(4-(4'-chlorophenoxy)phenoxy)propionic acid
- abt335
- abt335
- abt335
- abt 335
- abt-335
- abt-335
- abt-335
- abt-335
- antara
- antara
- choline fenofibrate
- choline fenofibrate
- choline fenofibrate
- choline fenofibrate
- choline fenofibrate
- choline fenofibrate
- choline ion
- choline ion
- choline ion
- clorofibrate
- fenobrate
- fenocor-67
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate
- fenofibrate / pravastatin
- fenofibrate / simvastatin
- fenofibrato
- fenofibrato
- fenofibratum
- fenofibratum
- fenofibric acid
- fenofibric acid
- fenofibric acid
- fenofibric acid
- fenofibric acid
- fenofibric acid
- fenofibric acid
- fenofibric acid potassium salt
- fenofibric acid, (r)-isomer
- fenofibric acid sodium salt
- fenogal
- fenogal
- fenoglide
- fenoglide
- fibrate
- fibricor
- fibricor
- finofibrate
- finofibrate
- fnf
- fnf
- hcg 004
- isopropyl 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionate
- isopropyl 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionate
- isopropyl (4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate
- isopropyl (4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate
- lipanthyl
- lipanthyl
- lipantil
- lipantil
- lipantil micro 200
- lipantil micro 267
- lipantil micro 67
- lipidil
- lipidil
- lipidil
- lipidil supra
- lipidil supra
- lipofen
- lipofen
- lipofene
- lofibra
- lofibra
- procetofen
- procetofen
- procetofen
- procetofene
- procetofenic acid
- supralip
- supralip
- supralip 160
- tricor
- tricor
- tricor
- triglide
- triglide
- trilipix
- trilipix
- trilipix
- trilipix
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07296458 | Phase 3 | Dec 17, 2025 | People's Liberation Army of China |
| NCT07025005 | Phase 4 | Aug 30, 2025 | Tanta University |
| NCT06905054 | Phase 2 | Apr 15, 2025 | Mayo Clinic |
| NCT07104201 | Early Phase 1 (Phase 1) | Mar 13, 2025 | People's Liberation Army of China |
| NCT06191133 | Phase 1 | Nov 1, 2024 | Case Western Reserve University |
| NCT06591455 | Early Phase 1 (Phase 1) | Sep 15, 2024 | People's Liberation Army of China |
| NCT06346743 | Phase 2/Phase 3 (Phase 3) | Apr 30, 2024 | Services Institute of Medical Sciences, Pakistan |
| NCT06293417 | N/A | Mar 1, 2024 | Korea University |
| NCT06755541 | Phase 3 | Jan 30, 2024 | People's Liberation Army of China |
| NCT06755151 | Phase 3 | Jan 17, 2024 | People's Liberation Army of China |
| NCT06155331 | Phase 4 | Dec 31, 2023 | Tanta University |
| NCT06174402 | Phase 2/Phase 3 (Phase 3) | Aug 21, 2023 | People's Liberation Army of China |
| NCT06451900 | Phase 4 | Jul 1, 2023 | Ain Shams University |
| NCT05365425 | Phase 4 | Jun 1, 2023 | Daewon Pharmaceutical Co., Ltd., Seoul National University |
| NCT05781698 | Phase 2 | Mar 20, 2023 | Menoufia University, Tanta University |
| NCT05753267 | Phase 2/Phase 3 (Phase 3) | Feb 28, 2023 | Menoufia University, Tanta University |
| NCT05751967 | Phase 3 | Feb 22, 2023 | People's Liberation Army of China |
| NCT05749822 | Phase 2/Phase 3 (Phase 3) | Feb 17, 2023 | People's Liberation Army of China |
| NCT05813145 | N/A | Jan 1, 2023 | Damanhour University |
| NCT05909800 | Phase 2 | Sep 29, 2022 | Children's Memorial Health Institute, Poland, Medical University of Warsaw |
Organizations
Research & Development (193)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Abbott | For profit | 20 | 12 | 5 | 2001 |
| Solvay | For profit | 17 | 17 | 3 | 2002 |
| People's Liberation Army of China | Government | 12 | 12 | 3 | 2016 |
| AstraZeneca | For profit | 11 | 11 | 3 | 2005 |
| Regeneron | For profit | 8 | 0 | 4 | 2012 |
| Sanofi | For profit | 8 | 8 | 4 | 2012 |
| Chong Kun Dang Pharmaceutical | For profit | 6 | 6 | 2 | 2013 |
| GlaxoSmithKline | For profit | 6 | 3 | 3 | 2001 |
| Merck | For profit | 6 | 4 | 5 | 2002 |
| Mutual Pharmaceutical | For profit | 6 | 6 | 1 | 2007 |
| National Institutes of Health (NIH) | Government | 6 | 1 | 4 | 2002 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 5 | 2 | 2 | 1999 |
| University of Pennsylvania | Academic/Hospital | 5 | 4 | 2 | 2005 |
| Department of Veteran Affairs | Government | 4 | 4 | 2 | 2005 |
| Gachon University | Academic/Hospital | 4 | 4 | 2 | 2005 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 4 | 1 | 4 | 1999 |
| PRACS | For profit | 4 | 0 | 1 | 2007 |
| Ranbaxy | For profit | 4 | 4 | 1 | 2002 |
| Shriners Hospitals for Children | Academic/Hospital | 4 | 0 | 3 | 2003 |
| Tanta University | Academic/Hospital | 4 | 4 | 3 | 2023 |
Marketing (64)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | NDA2 | Dec 31, 1993 |
| AbbVie | For profit | SYN | Sep 4, 2001 |
| Abbott | For profit | NDA | — |
| Actavis | For profit | MKTG | Oct 7, 2015 |
| Adaptis Pharma | For profit | MKTG | Aug 17, 2018 |
| Ajanta Pharma Ltd | For profit | MKTG | Jul 20, 2018 |
| Alembic | For profit | SYN | Feb 11, 2019 |
| Alembic | For profit | MKTG | May 12, 2017 |
| Alembic | For profit | SYN | May 12, 2017 |
| Allergan PLC (2015) | For profit | MKTG | Oct 7, 2015 |
| Amerigen Pharmaceuticals | For profit | MKTG | Apr 30, 2018 |
| Amneal Pharmaceuticals | For profit | MKTG | Feb 9, 2018 |
| Amneal Pharmaceuticals | For profit | SYN | Feb 9, 2018 |
| Anchen Pharmaceuticals, Inc | For profit | MKTG | Jul 18, 2013 |
| Ani Pharmaceuticals | For profit | MKTG | Apr 30, 2018 |
| Ani Pharmaceuticals | For profit | SYN | Apr 30, 2018 |
| Apotex | For profit | MKTG | Jul 26, 2013 |
| Apotex | For profit | SYN | Jul 26, 2013 |
| Appco Pharma | For profit | SYN | Sep 6, 2019 |
| Appco Pharma | For profit | MKTG | Sep 6, 2019 |
| Aurobindo Pharma | For profit | MKTG | May 5, 2016 |
| Aurobindo Pharma | For profit | SYN | May 5, 2016 |
| Austarpharma | For profit | MKTG | Nov 16, 2017 |
| Bausch Health Companies | For profit | MKTG | Apr 5, 2012 |
| CREEKWOOD PHARMS | For profit | MKTG | Sep 7, 2023 |
| Chartwell Pharmaceuticals | For profit | MKTG | Feb 11, 2019 |
| Cipher Pharmaceuticals Inc. | For profit | NDA2 | Jan 11, 2006 |
| Cipla | For profit | MKTG | Dec 15, 2016 |
| Dr. Reddy's Laboratories | For profit | MKTG | Mar 1, 2012 |
| Dr. Reddy's Laboratories | For profit | SYN | Sep 6, 2019 |
| Glenmark Pharmaceuticals | For profit | MKTG | Apr 7, 2017 |
| Graviti Pharmaceuticals | For profit | MKTG | Aug 17, 2018 |
| Hetero Labs Ltd | For profit | MKTG | Jul 12, 2016 |
| Impax Laboratories | For profit | MKTG | Oct 27, 2003 |
| Impax Laboratories | For profit | SYN | Sep 7, 2016 |
| Ingenus Pharmaceuticals | For profit | MKTG | Apr 19, 2019 |
| Invagen Pharms | For profit | MKTG | Mar 28, 2017 |
| Lupin | For profit | NDA2 | Nov 30, 2004 |
| Lupin | For profit | MKTG | Dec 23, 2011 |
| Lupin | For profit | SYN | Nov 30, 2004 |
| Mankind Pharma | For profit | MKTG | Jun 12, 2020 |
| MannKind Corp | For profit | MKTG | Jun 12, 2020 |
| Micro Labs Ltd India | For profit | MKTG | Jun 16, 2020 |
| Mylan | For profit | SYN | Oct 23, 2012 |
| Mylan | For profit | MKTG | Dec 29, 2005 |
| Novast Labs | For profit | MKTG | Apr 19, 2019 |
| Nuvo Research Inc. | For profit | MKTG | Sep 6, 2019 |
| Orit Labs Llc | For profit | MKTG | Feb 11, 2019 |
| Par Pharmaceuticals | For profit | MKTG | Jul 18, 2013 |
| Prinston Inc | For profit | MKTG | Aug 28, 2018 |
| Reyoung Pharma Co Ltd | For profit | MKTG | Nov 16, 2017 |
| Rhodes Pharmaceuticals, L.P. | For profit | MKTG | Apr 9, 2002 |
| Rising Pharmaceuticals | For profit | MKTG | Oct 23, 2012 |
| Rising Pharmaceuticals | For profit | SYN | Oct 23, 2012 |
| Salix | For profit | NDA2 | Aug 10, 2007 |
| Santarus | For profit | NDA2 | Aug 10, 2007 |
| ScinoPharm Taiwan | For profit | MKTG | Jul 5, 2019 |
| SkyePharma AG | For profit | NDA2 | May 7, 2005 |
| Sun Pharmaceuticals | For profit | MKTG | Oct 31, 2005 |
| Sun Pharmaceuticals | For profit | SYN | Sep 7, 2017 |
| TWi Biotechnology, Inc. | For profit | MKTG | Jul 5, 2019 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Jun 26, 2018 |
| University of Pennsylvania | Academic/Hospital | NDA2 | Aug 14, 2009 |
| Yichang Humanwell Pharmaceutical Co.,Ltd | For profit | MKTG | Dec 23, 2020 |