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Label indication VYTORIN VYTORIN ® is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). FDA label
Also known as MK0653A, Vytorin®
simvastatin ezetimibe · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Vytorin® | EXPERIMENTAL | simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks |
| atorvastatin | ACTIVE_COMPARATOR | atorvastatin 10 mg; tablet, once daily, 8 Weeks |
| Name | Type | Description |
|---|---|---|
| simvastatin (+) ezetimibe | DRUG | simvastatin (+) ezetimibe 10/20 mg ; tablet, once daily, 8 Weeks |
| Comparator: atorvastatin | DRUG | atorvastatin 10 mg; tablet, once daily, 8 Weeks |
Inclusion Criteria: * Diagnosis of the metabolic syndrome according to 2005 American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) scientific statement * No history of diabetes and 100 \<=LDL-C \<=250 mg/dl Exclusion Criteria: * Myocardial Infarction, coronary artery bypa...
Top 12 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 4 | PHASE3 | Enlicitide |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Inclisiran, Pelacarsen, DII235, QCZ484 |
| AstraZeneca PLC | AZN | 3 | PHASE3 | AZD0780, Laroprovstat, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 5 | PHASE3 | Plozasiran, zodasiran, VSA003 |
| Ionis Pharmaceuticals, Inc. | IONS | 2 | PHASE3 | Olezarsen, ION775 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE2 | Alirocumab |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Solbinsiran |
| MediciNova, Inc. | MNOV | 1 | PHASE2 | MN-001 |
| Verve Therapeutics, Inc. | VERV | 4 | PHASE2 | VERVE-102, VERVE-201 |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE1 | Obicetrapib |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| Esperion Therapeutics, Inc. | ESPR | 1 | - | Bempedoic acid+ Ezetimibe |
Simvastatin ezetimibe is a fixed-dose combination small molecule therapy being developed for hypercholesterolemia, a condition of elevated cholesterol in the blood. It combines two lipid-lowering agents in a single treatment and is also written as simvastatin (+) ezetimibe. Organon & Co. (ticker OGN) is the developer.
Simvastatin ezetimibe is used for hypercholesterolemia, meaning elevated cholesterol levels in the blood. It is a combination lipid-lowering product in the metabolic therapeutic area. The clinical program studied it in patients with hypercholesterolemia, including a Phase 3 trial conducted in patients with metabolic syndrome in Korea.
Simvastatin ezetimibe targets HMGCR, or HMG-CoA reductase, and acts as an inhibitor of that target. HMGCR is the rate-limiting enzyme in cholesterol synthesis, so inhibiting it reduces cholesterol production. The combination pairs this HMGCR inhibitor with a second lipid-lowering component in one oral small molecule product.
Organon & Co., which trades under the ticker OGN, is the developer of simvastatin ezetimibe. The company is listed as the sponsor of the clinical program for this hypercholesterolemia combination product.
Simvastatin ezetimibe has been studied in Phase 3 clinical development for hypercholesterolemia. It is an investigational combination product, and the Phase 3 trial in the program has been completed. The program includes one trial overall, with a total enrollment of 256 participants.
Simvastatin ezetimibe was evaluated in the Phase 3 trial NCT00496730, a multicenter, randomized, open label study comparing Vytorin 10/20 with atorvastatin 10 mg in hypercholesterolemia patients with metabolic syndrome in Korea. The trial enrolled 256 participants, was active controlled, and has been completed.