Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fenofibrate · 2 trials · 2 indications
Collection and measurement of blood samples.
Collection and measurement of blood samples.
Collection and measurement of blood samples.
| Arm | Type | Description |
|---|---|---|
| Fenofibrate/simvastatin 145/20 mg | EXPERIMENTAL | - |
| Simvastatin 20 mg | ACTIVE_COMPARATOR | - |
| Fenofibrate 145 mg | ACTIVE_COMPARATOR | - |
| Fenofibrate/simvastatin 145/40 mg | EXPERIMENTAL | - |
| Simvastatin 40 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fixed Combination of Fenofibrate/simvastatin 145/20 mg | DRUG | Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks |
| Simvastatin 20 mg | DRUG | Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks |
| Fenofibrate 145 mg | DRUG | Fenofibrate, tablet, 145 mg, once daily, 12 weeks |
| Fixed Combination of Fenofibrate/simvastatin 145/40 mg | DRUG | Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks |
| Simvastatin 40 mg | DRUG | simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks |
| fenofibrate | DRUG | - |
| ezetimibe | DRUG | - |
| atorvastatin | DRUG | - |
Inclusion Criteria: 1. Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide, Rosuvastatin |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | obicetrapib, ezetimibe daily |
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0780, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| HeartFlow, Inc. | HTFL | 1 | N/A | Rosuvastatin |
Fenofibrate is used for hyperlipidemia and dyslipidemia, conditions involving abnormal blood levels of fats (lipids). It is being studied as a treatment to improve lipid profiles in patients at high risk of cardiovascular disease.
Fenofibrate is developed by Abbott Laboratories, traded on the New York Stock Exchange under the ticker ABT.
Fenofibrate is in Phase 3 clinical development. It is an investigational small molecule for cardiovascular conditions and has not been approved by the FDA based on the available data.
Fenofibrate has completed two Phase 3 trials. NCT00195793 compared fenofibrate versus ezetimibe as add-on therapy to atorvastatin in hyperlipidemia. NCT01674712 studied fixed combinations of fenofibrate/simvastatin versus monotherapies in dyslipidemia.
Fenofibrate is a small molecule that targets lipid metabolism. It works by activating peroxisome proliferator-activated receptor alpha (PPAR-alpha), which helps regulate the breakdown and clearance of fats in the blood.
Fenofibrate is the single-agent drug, while the combination product includes fenofibrate plus simvastatin. The combination was studied in clinical trial NCT01674712 for dyslipidemia, but fenofibrate alone is a distinct medication.