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Placebo to ezetimibe/atorvastatin
Placebo to ezetimibe/atorvastatin is a Cholesterol absorption inhibitor/HMG-CoA reductase inhibitor Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Hyperlipidemia, Homozygous familial hypercholesterolemia.
Ezetimibe inhibits the absorption of cholesterol in the small intestine, while atorvastatin inhibits HMG-CoA reductase to reduce cholesterol production in the liver.
Ezetimibe inhibits the absorption of cholesterol in the small intestine, while atorvastatin inhibits HMG-CoA reductase to reduce cholesterol production in the liver. Used for Hyperlipidemia, Homozygous familial hypercholesterolemia.
At a glance
| Generic name | Placebo to ezetimibe/atorvastatin |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Cholesterol absorption inhibitor/HMG-CoA reductase inhibitor |
| Target | NPC1L1/HMG-CoA reductase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Ezetimibe works by binding to the Niemann-Pick C1-like 1 (NPC1L1) protein on intestinal cells, preventing the absorption of cholesterol from the diet. Atorvastatin, on the other hand, inhibits the enzyme HMG-CoA reductase, which is involved in the production of cholesterol in the liver. By reducing both dietary and endogenous cholesterol, ezetimibe/atorvastatin helps to lower LDL cholesterol levels in the blood.
Approved indications
- Hyperlipidemia
- Homozygous familial hypercholesterolemia
Common side effects
- Musculoskeletal pain
- Liver enzyme elevation
- Diarrhea
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (PHASE3)
- An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED) (PHASE3)
- Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803) (PHASE3)
- A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077) (PHASE3)
- A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128) (PHASE3)
- Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED) (PHASE3)
- A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383) (PHASE3)
- Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439) (PHASE3)
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:
- Placebo to ezetimibe/atorvastatin CI brief — competitive landscape report
- Placebo to ezetimibe/atorvastatin updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Placebo to ezetimibe/atorvastatin
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Related
- Drug class: All Cholesterol absorption inhibitor/HMG-CoA reductase inhibitor drugs
- Target: All drugs targeting NPC1L1/HMG-CoA reductase
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hyperlipidemia
- Indication: Drugs for Homozygous familial hypercholesterolemia
- Compare: Placebo to ezetimibe/atorvastatin vs similar drugs
- Pricing: Placebo to ezetimibe/atorvastatin cost, discount & access