Wednesday, July 8, 2026

Drug profile · INN

ezetimibe

ezetimibe (APO-EZETIMIBE) is a niemann-pick c1-like protein 1 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved PMDA: approved NMPA: clinical trials
US status approved
Patents linked 10
Pipeline programs 14
News articles 0
Drug details — ezetimibe
US status
approved
Class
Route
ORAL
Patents
10
Programs
14
Data quality
0.89

Quick answer

ezetimibe (APO-EZETIMIBE) is a niemann-pick c1-like protein 1 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ezetimibe
Brand APO-EZETIMIBE
Mechanism Niemann-Pick C1-like protein 1 inhibitor
Target NPC1-like intracellular cholesterol transporter 1
Route ORAL
Formulation TABLET

Mechanism of action

Niemann-Pick C1-like protein 1 inhibitor

Primary target: NPC1-like intracellular cholesterol transporter 1

Approval history

Authority Status Date
FDA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. Bempedoic Acid + Ezetimibe Fixed-Dose Combination Phase 3 · Esperion Therapeutics · Hyperlipidemias
  2. MK-0616-018 Phase 3 · MSD Merck Sharp · Hypercholesterolemia
  3. OBEZ-302 Phase 3 · Anaxis Pharma · Atherosclerotic Cardiovascular Disease
  4. OBEZ-303 Phase 3 · Anaxis Pharma · Adults with Type 2 Diabetes and/or Metabolic Syndrome on gu
  5. Bempedoic acid + Ezetimibe FDC Oral Tablet Phase 2 · Esperion Therapeutics · Diabetes
  6. Bioequivalence clinical trial of two formulations of ezetimibe/atorvastatin Phase 1 · Tillomed Laboratories · Healthy volunteers
  7. DSE-BMP-0001-CIS-MA Phase 1 · Daiichi Sankyo US · No medical condition.
  8. DSE-BMP-0002-CIS-MA Phase 1 · Daiichi Sankyo US · No medical condition
  1. US 12404227

    Methods of making bempedoic acid and compositions of the same

    Expires Mon Aug 28 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12398087

    Methods of making bempedoic acid and compositions of the same

    Expires Mon Aug 21 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11926584

    Methods of making bempedoic acid and compositions of the same

    Expires Mon Mar 07 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11760714

    Methods of making bempedoic acid and compositions of the same

    Expires Mon Sep 14 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11744816

    Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease

    Expires Mon Aug 31 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11613511

    Methods of making bempedoic acid and compositions of the same

    Expires Mon Mar 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 10912751

    Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease

    Expires Mon Feb 04 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 10905736

    Ezetimibe-associated ApoA-I mimetic peptides showing enhanced synergism

    Expires Mon Jan 28 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 9095515

    Ezetimibe compositions

    Expires Mon Jul 30 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 7335799

    Hydroxyl compounds and compositions for cholesterol management and related uses

    Expires Mon Feb 21 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ezetimibe?

ezetimibe (APO-EZETIMIBE) is a niemann-pick c1-like protein 1 inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ezetimibe?

APO-EZETIMIBE is a marketed brand name for ezetimibe. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ezetimibe?

ezetimibe has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.