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Primary Hypercholesterolemia

33
Pipeline Programs
14
Companies
22
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
0
3
0
23
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
975%
RNA Therapeutic
325%
+ 27 programs with unclassified modality

On Market (1)

Approved therapies currently available

Merck & Co.
ZETIAApproved
ezetimibe
Merck & Co.
Dietary Cholesterol Absorption Inhibitor [EPC]oral2002
7M Part D

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
3 programs
1
inclisiranPhase 4RNA Therapeutic
InclisiranN/ARNA Therapeutic
InclisiranN/ARNA Therapeutic
Merck & Co.
Merck & Co.RAHWAY, NJ
3 programs
1
Comparator: simvastatinPHASE_3Small Molecule
ezetimibePHASE_3
niacinPHASE_3
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
P-OM3Phase 4
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
9 programs
1
1
7
Comparator: simvastatinPhase 3Small Molecule
Comparator: simvastatinPhase 3Small Molecule
ER niacin/laropiprantPhase 3
Extended-release niacin/laropiprantPhase 3
SimvastatinPhase 3Small Molecule
+4 more programs
MSD
MSDIreland - Ballydine
9 programs
1
1
7
Comparator: simvastatinPhase 3Small Molecule1 trial
Comparator: simvastatinPhase 3Small Molecule1 trial
ER niacin/laropiprantPhase 31 trial
Extended-release niacin/laropiprantPhase 31 trial
SimvastatinPhase 3Small Molecule1 trial
+4 more programs
Active Trials
NCT01012219Completed36Est. Apr 2010
NCT00941603Completed619Est. Feb 2010
NCT00479388Completed1,216Est. Oct 2008
+6 more trials
Hanlim Pharm
Hanlim PharmKorea - Seoul
3 programs
1
2
Experimental : Ezetimibe / Rosuvastatin + TelmisartanPhase 3Small Molecule1 trial
HL140 5/10Phase 31 trial
Crecheck Tablet 2.5 mgPhase 11 trial
Active Trials
NCT06475872Completed36Est. Dec 2023
NCT04659070Unknown156Est. May 2022
NCT03571087Completed374Est. Sep 2015
Hanmi Pharmaceutical
3 programs
1
2
HGP0816 5mgPhase 31 trial
HGP1910Phase 31 trial
HGP0816Phase 11 trial
Active Trials
NCT02941848Completed60Est. Jan 2015
NCT02205606Completed412Est. Apr 2015
NCT04652349Completed279Est. Jan 2021
Alvogen
AlvogenNJ - Morristown
2 programs
2
Rosuvastatin 5mgPhase 31 trial
rosuvastatin and ezetimibePhase 3
Active Trials
NCT02445352Completed379Est. Mar 2015
Chong Kun Dang Pharmaceutical
1 program
1
D377Phase 31 trial
Active Trials
NCT05657574Unknown228Est. Jun 2023
Daewon Pharma
Daewon PharmaKorea - Hwaseong
1 program
1
DW5421APhase 31 trial
Active Trials
NCT07444762Completed184Est. Oct 2025
JW Pharmaceutical
JW PharmaceuticalKorea - Seoul
1 program
1
Livalo, EzetrolPhase 31 trial
Active Trials
NCT04584736Completed283Est. Oct 2020
Biocorp
BiocorpFrance - Issoire
1 program
1
EprotiromePhase 21 trial
Active Trials
NCT00776321Completed142Est. Oct 2007
Daiichi Sankyo
Daiichi SankyoChina - Shanghai
1 program
Bempedoic acid and/or its fixed dose combination with ezetimibeN/A1 trial
Active Trials
NCT05798390Withdrawn0Est. Apr 2026
Hikma
HikmaNJ - Berkeley Heights
1 program
RosuvastatinN/ASmall Molecule1 trial
Active Trials
NCT03516955Completed317Est. Aug 2015

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Daewon PharmaDW5421A
Chong Kun Dang PharmaceuticalD377
Hanlim PharmExperimental : Ezetimibe / Rosuvastatin + Telmisartan
Hanmi PharmaceuticalHGP1910
JW PharmaceuticalLivalo, Ezetrol
Hanlim PharmHL140 5/10
AlvogenRosuvastatin 5mg
Hanmi PharmaceuticalHGP0816 5mg
MSDER niacin/laropiprant
MSDExtended-release niacin/laropiprant
MSDSimvastatin
MSDezetimibe
MSDComparator: simvastatin
MSDComparator: simvastatin
MSDniacin

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 11,962 patients across 22 trials

Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421A

Start: Apr 2025Est. completion: Oct 2025184 patients
Phase 3Completed

A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia

Start: Nov 2022Est. completion: Jun 2023228 patients
Phase 3Unknown
NCT04659070Hanlim PharmExperimental : Ezetimibe / Rosuvastatin + Telmisartan

To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia

Start: Jul 2020Est. completion: May 2022156 patients
Phase 3Unknown

Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

Start: Jul 2020Est. completion: Jan 2021279 patients
Phase 3Completed

To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

Start: Jun 2019Est. completion: Oct 2020283 patients
Phase 3Completed

Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

Start: Sep 2014Est. completion: Sep 2015374 patients
Phase 3Completed
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

Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

Start: Jun 2014Est. completion: Apr 2015412 patients
Phase 3Completed
NCT01335997MSDER niacin/laropiprant

Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)

Start: May 2011Est. completion: Jan 20121,139 patients
Phase 3Terminated
NCT01274559MSDExtended-release niacin/laropiprant

Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)

Start: Mar 2011Est. completion: Feb 20131,173 patients
Phase 3Terminated
NCT01294683MSDSimvastatin

A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)

Start: Feb 2011Est. completion: Jan 2012977 patients
Phase 3Terminated

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
NCT00479388MSDComparator: simvastatin

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

Start: Jul 2007Est. completion: Oct 20081,216 patients
Phase 3Completed
NCT00479882MSDComparator: simvastatin

MK-0524B Lipid Study (MK-0524B-063)

Start: Jun 2007Est. completion: Jun 20082,414 patients
Phase 3Completed

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

Start: Jan 2006Est. completion: Jan 20071,400 patients
Phase 3Completed
NCT00941603MSDSCH 900271 15mg

Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)

Start: Jun 2009Est. completion: Feb 2010619 patients
Phase 2Completed

Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

Start: Sep 2006Est. completion: Oct 2007142 patients
Phase 2Completed
NCT06475872Hanlim PharmCrecheck Tablet 2.5 mg

Study to Evaluate the Bioequivalence of "Crecheck Tablet 2.5 mg (Rosuvastatin Calcium)" and "Crestor Tablet 5 mg (Rosuvastatin Calcium)" in Healthy Adult Subjects

Start: Nov 2023Est. completion: Dec 202336 patients
Phase 1Completed

Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers

Start: Nov 2014Est. completion: Jan 201560 patients
Phase 1Completed

A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED)

Start: Nov 2009Est. completion: Apr 201036 patients
Phase 1Completed
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
NCT03516955HikmaRosuvastatin

Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting

Start: Nov 2014Est. completion: Aug 2015317 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

23 late-stage (Phase 3) programs, potential near-term approvals
14 companies competing in this space

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.