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Ezetimibe/Rosuvastatin
Ezetimibe/Rosuvastatin is a Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor (statin combination) Small molecule drug developed by Addpharma Inc.. It is currently FDA-approved for Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk. Also known as: Rosuvamibe Tab., Ezetimibe/Rosuvastatin 10 mg/10 mg, Rosuzet, Crezet Tablet.
This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting HMG-CoA reductase to decrease hepatic cholesterol synthesis (rosuvastatin).
This combination reduces cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting HMG-CoA reductase to decrease hepatic cholesterol synthesis (rosuvastatin). Used for Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk.
At a glance
| Generic name | Ezetimibe/Rosuvastatin |
|---|---|
| Also known as | Rosuvamibe Tab., Ezetimibe/Rosuvastatin 10 mg/10 mg, Rosuzet, Crezet Tablet |
| Sponsor | Addpharma Inc. |
| Drug class | Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor (statin combination) |
| Target | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (rosuvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Ezetimibe selectively inhibits the Niemann-Pick C1-like 1 (NPC1L1) transporter in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Rosuvastatin is a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. Together, they provide complementary mechanisms to lower LDL cholesterol and reduce cardiovascular risk.
Approved indications
- Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk
Common side effects
- Myalgia
- Elevated liver enzymes
- Headache
- Abdominal pain
- Rhabdomyolysis (rare)
Key clinical trials
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (PHASE3)
- Moderate-intensity Statin vs. Individualized LDL-C Target-based Therapy in Older Adults With Type 2 Diabetes (iTARGET-Elderly Study) (NA)
- A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial (NA)
- Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM) (PHASE4)
- Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis (PHASE2)
- LATAM LOWERS LDL-C (PHASE4)
- Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ezetimibe/Rosuvastatin CI brief — competitive landscape report
- Ezetimibe/Rosuvastatin updates RSS · CI watch RSS
- Addpharma Inc. portfolio CI
Frequently asked questions about Ezetimibe/Rosuvastatin
What is Ezetimibe/Rosuvastatin?
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Is Ezetimibe/Rosuvastatin also known as anything else?
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Related
- Drug class: All Cholesterol absorption inhibitor + HMG-CoA reductase inhibitor (statin combination) drugs
- Target: All drugs targeting NPC1L1 transporter (ezetimibe); HMG-CoA reductase (rosuvastatin)
- Manufacturer: Addpharma Inc. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk
- Also known as: Rosuvamibe Tab., Ezetimibe/Rosuvastatin 10 mg/10 mg, Rosuzet, Crezet Tablet
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing