Last reviewed · How we verify
Placebo to Ezetimibe
Ezetimibe inhibits cholesterol absorption in the small intestine by blocking the Niemann-Pick C1-Like 1 (NPC1L1) transporter.
Ezetimibe inhibits cholesterol absorption in the small intestine by blocking the Niemann-Pick C1-Like 1 (NPC1L1) transporter. Used for Hypercholesterolemia (primary and secondary prevention of cardiovascular disease), Adjunctive therapy to statins for LDL cholesterol reduction.
At a glance
| Generic name | Placebo to Ezetimibe |
|---|---|
| Sponsor | Amgen |
| Drug class | Cholesterol absorption inhibitor |
| Target | NPC1L1 (Niemann-Pick C1-Like 1) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Ezetimibe selectively inhibits the NPC1L1 cholesterol transporter located on the brush border of the small intestine, reducing the absorption of dietary and biliary cholesterol. This leads to decreased plasma LDL cholesterol levels and increased hepatic cholesterol uptake. It is often used as an adjunct to statins or as monotherapy for cholesterol management.
Approved indications
- Hypercholesterolemia (primary and secondary prevention of cardiovascular disease)
- Adjunctive therapy to statins for LDL cholesterol reduction
Common side effects
- Abdominal pain
- Diarrhea
- Fatigue
- Arthralgia
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) (PHASE3)
- A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (PHASE3)
- Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides (PHASE4)
- Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) (PHASE3)
- A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C. (PHASE1)
- Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. (PHASE3)
- Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies (PHASE3)
- A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy (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 CI brief — competitive landscape report
- Placebo to Ezetimibe updates RSS · CI watch RSS
- Amgen portfolio CI