Primary Hypercholesterolemia

7
Pipeline Programs
4
Companies
6
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
5
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 5 programs with unclassified modality

On Market (2)

Approved therapies currently available

U
NIACORApproved
niacin
Unknown Company
Nicotinic Acid [EPC]oral2000
M&
ZETIAApproved
ezetimibe
Merck & Co.
Dietary Cholesterol Absorption Inhibitor [EPC]oral2002

Competitive Landscape

4 companies ranked by most advanced pipeline stage

M&
Merck & Co.RAHWAY, NJ
3 programs
3
1
Comparator: simvastatinPhase 3Small Molecule1 trial
ezetimibePhase 31 trial
niacinPhase 31 trial
Active Trials
NCT00479388Completed1,216Est. Oct 2008
NCT00867165Completed138Est. Apr 2012
NCT00269217Completed1,400Est. Jan 2007
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
Evolocumab AMDPhase 31 trial
Active Trials
NCT01879319Completed164
Alvogen
AlvogenNJ - Morristown
1 program
1
Rosuvastatin 5mgPhase 31 trial
Active Trials
NCT02445352Completed379Est. Mar 2015
DS
Daiichi SankyoChina - Shanghai
1 program
Bempedoic acid and/or its fixed dose combination with ezetimibeN/A1 trial
Active Trials
NCT05798390Withdrawn0Est. Apr 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AlvogenRosuvastatin 5mg
AmgenEvolocumab AMD
Merck & Co.ezetimibe
Merck & Co.Comparator: simvastatin
Merck & Co.niacin
Daiichi SankyoBempedoic acid and/or its fixed dose combination with ezetimibe

Clinical Trials (6)

Total enrollment: 3,297 patients across 6 trials

NCT02445352AlvogenRosuvastatin 5mg

Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

Start: Jul 2014Est. completion: Mar 2015379 patients
Phase 3Completed
NCT01879319AmgenEvolocumab AMD

Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen

Start: Jul 2013164 patients
Phase 3Completed
NCT00867165Merck & Co.ezetimibe

Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)

Start: May 2009Est. completion: Apr 2012138 patients
Phase 3Completed
NCT00479388Merck & Co.Comparator: simvastatin

Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Start: Jul 2007Est. completion: Oct 20081,216 patients
Phase 3Completed
NCT00269217Merck & Co.niacin

Lipid Efficacy Study (0524B-022)(COMPLETED)

Start: Jan 2006Est. completion: Jan 20071,400 patients
Phase 3Completed
NCT05798390Daiichi SankyoBempedoic acid and/or its fixed dose combination with ezetimibe

Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia

Start: Sep 2023Est. completion: Apr 20260
N/AWithdrawn

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
4 companies competing in this space