Hypercholesterolaemia

6
Pipeline Programs
5
Companies
4
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
1
0
1
0
3
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1100%
+ 7 programs with unclassified modality

On Market (1)

Approved therapies currently available

Regeneron
PRALUENTApproved
alirocumab
Regeneron
PCSK9 Inhibitor [EPC]injection2015

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Regeneron
RegeneronTARRYTOWN, NY
4 programs
1
3
1
AlirocumabPhase 3Monoclonal Antibody
Alirocumab SAR236553Phase 3
Alirocumab SAR236553Phase 3
alirocumab SAR236553Phase 2
M&
Merck & Co.RAHWAY, NJ
1 program
1
Enlicitide DecanoatePhase 11 trial
Active Trials
NCT05934292Completed33Est. Jan 2024
Amgen
AmgenTHOUSAND OAKS, CA
2 programs
Chart Review of Repatha® in Subjects With HyperlipidaemiaN/A1 trial
Study to Evaluate the Safety of Repatha® in PregnancyN/A1 trial
Active Trials
NCT02770131Completed1,986Est. Jun 2021
NCT02906124Terminated4Est. Nov 2020
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target ValuesN/A1 trial
Active Trials
NCT01483950Completed800Est. Jan 2013

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Merck & Co.Enlicitide Decanoate
AmgenStudy to Evaluate the Safety of Repatha® in Pregnancy
AmgenChart Review of Repatha® in Subjects With Hyperlipidaemia
AstraZenecaEvaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

Clinical Trials (4)

Total enrollment: 2,823 patients across 4 trials

NCT05934292Merck & Co.Enlicitide Decanoate

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)

Start: Jul 2023Est. completion: Jan 202433 patients
Phase 1Completed
NCT02906124AmgenStudy to Evaluate the Safety of Repatha® in Pregnancy

Study to Evaluate the Safety of Repatha® in Pregnancy

Start: Jan 2017Est. completion: Nov 20204 patients
N/ATerminated
NCT02770131AmgenChart Review of Repatha® in Subjects With Hyperlipidaemia

Chart Review of Repatha® in Subjects With Hyperlipidaemia

Start: May 2016Est. completion: Jun 20211,986 patients
N/ACompleted
NCT01483950AstraZenecaEvaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

Evaluation of Patients Treated With HMG-CoA Reductase Inhibitors to Reach Cholesterol Target Values

Start: Apr 2012Est. completion: Jan 2013800 patients
N/ACompleted

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

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