Hyperlipidemia

10
Pipeline Programs
11
Companies
14
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
5
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
350%
Small Molecule
233%
RNA Therapeutic
117%
+ 6 programs with unclassified modality

On Market (1)

Approved therapies currently available

Amgen
REPATHAApproved
evolocumab
Amgen
PCSK9 Inhibitor [EPC]injection2015

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Amgen
AmgenTHOUSAND OAKS, CA
2 programs
1
1
1
EvolocumabPhase 3Monoclonal Antibody1 trial
EvolocumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT01380730Completed631Est. Apr 2012
NCT01763918Completed331Est. Dec 2013
Takeda
TakedaTOKYO, Japan
2 programs
2
TAK-085Phase 41 trial
TAK-085Phase 41 trial
Active Trials
NCT02824432Completed37Est. Aug 2017
NCT02839902Completed53Est. Aug 2017
DS
Daiichi SankyoChina - Shanghai
1 program
1
Minute Maid Heart Wise orange juicePhase 41 trial
Active Trials
NCT00249938Completed60Est. Aug 2006
M&
Merck & Co.RAHWAY, NJ
1 program
1
Self Monitoring Lipid AnalyzerPhase 41 trial
Active Trials
NCT01212159Completed70Est. Aug 2015
Pfizer
PfizerNEW YORK, NY
4 programs
2
BococizumabPhase 3Monoclonal Antibody3 trials
torcetrapib/atorvastatinPhase 3Small Molecule1 trial
AtorvastatinN/ASmall Molecule1 trial
Lipid Self TestN/A1 trial
Active Trials
NCT00172419Completed43Est. Dec 2008
NCT00828945Completed259Est. Mar 2011
NCT02667223Terminated60Est. Jul 2016
+3 more trials
Novartis
NovartisBASEL, Switzerland
1 program
1
100 mg inclisiran sodiumPhase 1RNA Therapeutic1 trial
Active Trials
NCT04774003Completed40Est. Oct 2021
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and Rate of Patients Achieving N/A1 trial
Active Trials
NCT00781560Completed2,575Est. Jul 2009

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
TakedaTAK-085
TakedaTAK-085
Merck & Co.Self Monitoring Lipid Analyzer
Daiichi SankyoMinute Maid Heart Wise orange juice
PfizerBococizumab
AmgenEvolocumab
Pfizertorcetrapib/atorvastatin
AmgenEvolocumab
Novartis100 mg inclisiran sodium
PfizerBococizumab
PfizerBococizumab
PfizerLipid Self Test
AstraZenecaAwareness of Chinese National Adult Lipid Treatment Guideline (2007) and Rate of Patients Achieving
PfizerAtorvastatin

Clinical Trials (14)

Total enrollment: 6,373 patients across 14 trials

NCT02839902TakedaTAK-085

Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood

Start: Dec 2016Est. completion: Aug 201753 patients
Phase 4Completed
NCT02824432TakedaTAK-085

Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation

Start: Aug 2016Est. completion: Aug 201737 patients
Phase 4Completed
NCT01212159Merck & Co.Self Monitoring Lipid Analyzer

Telephone Based Management of Hyperlipidemia

Start: Nov 2010Est. completion: Aug 201570 patients
Phase 4Completed
NCT00249938Daiichi SankyoMinute Maid Heart Wise orange juice

Evaluation of Combination Cholesterol Treatments in Patients With High Cholesterol.

Start: Mar 2005Est. completion: Aug 200660 patients
Phase 4Completed
NCT01968967PfizerBococizumab

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

Start: Oct 2013Est. completion: Jul 20172,139 patients
Phase 3Completed
NCT01763918AmgenEvolocumab

Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

Start: Feb 2013Est. completion: Dec 2013331 patients
Phase 3Completed
NCT00267254Pfizertorcetrapib/atorvastatin

A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.

Start: Jan 2006Est. completion: Aug 2006
Phase 3Completed
NCT01380730AmgenEvolocumab

LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

Start: Jul 2011Est. completion: Apr 2012631 patients
Phase 2Completed
NCT04774003Novartis100 mg inclisiran sodium

Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C

Start: Feb 2021Est. completion: Oct 202140 patients
Phase 1Completed
NCT02667223PfizerBococizumab

Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase

Start: Feb 2016Est. completion: Jul 201660 patients
Phase 1Terminated
NCT02043301PfizerBococizumab

Pharmacokinetics And Relative Bioavailability Of Bococizumab (PF-04950615; RN316) When Administered To The Abdomen, Thigh Or Upper Arm

Start: Apr 2014Est. completion: Nov 201475 patients
Phase 1Completed
NCT00828945PfizerLipid Self Test

Compliance With Treatment For Patients With Hyperlipidemia

Start: Feb 2009Est. completion: Mar 2011259 patients
N/ACompleted
NCT00781560AstraZenecaAwareness of Chinese National Adult Lipid Treatment Guideline (2007) and Rate of Patients Achieving

Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and Rate of Patients Achieving the Treatment Goal

Start: Oct 2008Est. completion: Jul 20092,575 patients
N/ACompleted
NCT00172419PfizerAtorvastatin

The Effects of Atorvastatin on Vulnerable Plaques in Untreated Dyslipidemic Patients.

Start: Mar 2007Est. completion: Dec 200843 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
11 companies competing in this space