NDAORALTABLET
Approved
Oct 2002
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
20
Data completeness
5/8 — Partial
ZETIA (ezetimibe) by Merck & Co. is intestine. First approved in 2002.
Drug data last refreshed 15h ago · AI intelligence enriched 18h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZETIA (ezetimibe) is an oral small-molecule dietary cholesterol absorption inhibitor approved in 2002 for reducing LDL cholesterol. It works by blocking the Niemann-Pick C1-Like 1 (NPC1L1) sterol transporter at the intestinal brush border, preventing cholesterol and phytosterol absorption and increasing hepatic LDL receptor expression. Ezetimibe is typically used as monotherapy or in combination with statins for hypercholesterolemia management.
$0.007BPart D
Post-LOEDeclining
Post-LOEZETIA is in post-LOE phase with modest Part D utilization, indicating a mature product with smaller commercial team and focus on maintenance rather than growth.
Mechanism of Action
intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of…
Pharmacologic Class:
Dietary Cholesterol Absorption Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
Started Aug 2026
103 enrolled
Coronary AtherosclerosisMixed DyslipidemiaHypercholesterolemia
A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults
Started Jun 2026
18 enrolled
Healthy Participants
A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia
Started Mar 2026
2,120 enrolled
Primary HypercholesterolaemiaMixed Dyslipidemia
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
Started Dec 2025
300 enrolled
LipidemiaType 2 Diabetes (T2DM)Metabolic Syndrome (MetS)
Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin
Started Dec 2025
58 enrolled
Healthy Subjects
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.