Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fixed Combination of Fenofibrate/simvastatin 145 · 1 trial · 1 indication
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 |
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 ...
Top 7 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Enlicitide |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran, Muvalaplin |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Pelacarsen |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | Obicetrapib |
| AstraZeneca PLC | AZN | 2 | PHASE2 | Rosuvastatin, AZD0780, AZD4954 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
The Fixed Combination of Fenofibrate/simvastatin 145 is being developed for dyslipidemia, a condition marked by abnormal blood levels of fats such as cholesterol and triglycerides. It is intended for patients at high risk of cardiovascular disease. The fixed-dose combination pairs fenofibrate with simvastatin in a single tablet.
Abbott Laboratories, which trades under the ticker ABT, is the developer of the Fixed Combination of Fenofibrate/simvastatin 145. The company is studying the fixed-dose combination of fenofibrate and simvastatin for dyslipidemia in patients at high cardiovascular risk.
The Fixed Combination of Fenofibrate/simvastatin 145 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.
The Fixed Combination of Fenofibrate/simvastatin 145 has been evaluated in the completed Phase 3 trial NCT01674712. This randomized, double-blind, active-controlled study enrolled 575 adults with dyslipidemia and compared fenofibrate/simvastatin 145/20 mg and 145/40 mg tablets against fenofibrate or simvastatin monotherapy. It ran in Argentina, Czechia, Germany, Mexico, Poland, Romania, and Russia.