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SPC ezetimibe/rosuvastatin · 1 trial · 1 indication
The percent change from baseline in measured LDL-C at Week 8 will be analyzed in the modified intent-to-treat (mITT) population using a mixed effect model with repeated measures (MMRM) approach.
| Arm | Type | Description |
|---|---|---|
| Single pill combination (SPC) | EXPERIMENTAL | Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks |
| Rosuvastatin | ACTIVE_COMPARATOR | Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks |
| Name | Type | Description |
|---|---|---|
| Rosuvastatin | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
| SPC ezetimibe/rosuvastatin | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
| Rosuvastatin active capsule | DRUG | Pharmaceutical form:Capsule Route of administration: Oral |
| Placebo | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
Inclusion criteria : * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent. * Patients with primary hypercholesterolemia. * Inclusion criteria in the run-in period: Participants who are not adequately controlled (defined by screening LDL-C \>2.6 mmol/...
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 |
SPC ezetimibe/rosuvastatin is a single pill combination used for hypercholesterolemia, specifically in Chinese adult patients with primary hypercholesterolemia not adequately controlled on statin therapy. It is a small molecule being developed by Sanofi and is currently in Phase 3 clinical development.
SPC ezetimibe/rosuvastatin combines two active ingredients: ezetimibe, which inhibits cholesterol absorption in the intestine, and rosuvastatin, a statin that inhibits HMG-CoA reductase to reduce cholesterol synthesis. Together they lower LDL cholesterol levels in patients with hypercholesterolemia.
SPC ezetimibe/rosuvastatin is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 3 clinical development for the treatment of hypercholesterolemia.
SPC ezetimibe/rosuvastatin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with 305 participants enrolled.
SPC ezetimibe/rosuvastatin has one completed Phase 3 trial, NCT04669041, which evaluated its efficacy and safety in Chinese adult patients with primary hypercholesterolemia not adequately controlled on statin therapy. The trial enrolled 305 participants and was randomized, double-blind, and active-controlled.