CLINICAL TRIALS PROFILE FOR PRALUENT

All Clinical Trials for PRALUENT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01507831 ↗	Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)	Completed	Regeneron Pharmaceuticals	Phase 3	2012-01-01	Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters.
NCT01507831 ↗	Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)	Completed	Sanofi	Phase 3	2012-01-01	Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters.
NCT01576484 ↗	Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)	Completed	Sanofi	Phase 2	2012-02-28	The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
NCT01576484 ↗	Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)	Completed	Regeneron Pharmaceuticals	Phase 2	2012-02-28	The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).
NCT01617655 ↗	Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)	Completed	Regeneron Pharmaceuticals	Phase 3	2012-06-01	Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points - To evaluate the effects of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab
NCT01617655 ↗	Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)	Completed	Sanofi	Phase 3	2012-06-01	Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points - To evaluate the effects of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab

Clinical Trial Conditions for PRALUENT

Condition Name

Condition Name for PRALUENT
Intervention	Trials
Hypercholesterolemia	11
Hypercholesterolaemia	4
Atherosclerosis	3
Heterozygous Familial Hypercholesterolemia	2

Condition MeSH

Condition MeSH for PRALUENT
Intervention	Trials
Hypercholesterolemia	17
Hyperlipoproteinemia Type II	8
Atherosclerosis	6
Dyslipidemias	3

Clinical Trial Locations for PRALUENT

Trials by Country

Trials by Country for PRALUENT
Location	Trials
United States	239
United Kingdom	27
South Africa	23
Canada	13
Hungary	10

Trials by US State

Trials by US State for PRALUENT
Location	Trials
Ohio	13
North Carolina	12
Missouri	12
Florida	12
California	12

Clinical Trial Progress for PRALUENT

Clinical Trial Phase

Clinical Trial Phase for PRALUENT
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	9
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PRALUENT
Clinical Trial Phase	Trials
Completed	17
Active, not recruiting	3
Terminated	3

Clinical Trial Sponsors for PRALUENT

Sponsor Name

Sponsor Name for PRALUENT
Sponsor	Trials
Regeneron Pharmaceuticals	22
Sanofi	18
University of Virginia	1

Sponsor Type

Sponsor Type for PRALUENT
Sponsor	Trials
Industry	41
Other	18
U.S. Fed	1

PRALUENT (alirocumab) Clinical Trials Update and Market Projection

Last updated: April 24, 2026

What is PRALUENT and where does it sit clinically?

PRALUENT is the PCSK9 monoclonal antibody (alirocumab) for lowering LDL-C in patients with hypercholesterolemia and related cardiovascular risk. The product’s clinical profile is anchored by large outcomes data and a broad label focused on lipid lowering and cardiovascular event reduction in defined high-risk populations.

Core clinical positioning (label-consistent categories)

• Established ASCVD (secondary prevention; used to reduce risk of major adverse cardiovascular events in high-risk patients)
• Heterozygous familial hypercholesterolemia (HeFH) and primary hypercholesterolemia
• Homozygous familial hypercholesterolemia (HoFH), including use in combination regimens depending on background therapy
• Adjunct to diet and other lipid-lowering therapies where LDL-C remains above thresholds

Outcomes evidence basis

• The pivotal cardiovascular outcomes trial ODYSSEY OUTCOMES showed that alirocumab reduced ischemic events vs placebo in post-acute coronary syndrome patients (median follow-up 2.8 years). The trial reported a significant reduction in the composite of major adverse cardiovascular events (MACE), with additional benefit in key endpoints in pre-specified analyses. [1]

What clinical trials are active or have driven recent updates?

A comprehensive “active trials” refresh is not computable from the information provided in this session. The only rigorous, citeable clinical trial anchor available here is ODYSSEY OUTCOMES, which established outcomes benefit. [1]

Primary clinical outcomes trial (anchor)

• ODYSSEY OUTCOMES (alirocumab vs placebo)
  • Population: recent ACS
  • Endpoints: MACE and related ischemic outcomes
  • Result: significant reduction in MACE vs placebo [1]

How does PRALUENT’s evidence compare with the PCSK9 class?

PRALUENT competes in the PCSK9 inhibitor class dominated by two mAbs: alirocumab (PRALUENT) and evolocumab. From an evidence standpoint, PRALUENT’s outcomes readout is anchored by ODYSSEY OUTCOMES, while class comparators have their own outcomes programs. For business decisions, the practical takeaway is that PRALUENT’s positioning rests on outcomes data in post-ACS patients and on durable LDL-C lowering across hypercholesterolemia phenotypes. [1]

What is the market structure for PCSK9 inhibitors?

The PCSK9 market is structured around:

• Route of administration: subcutaneous self-injection
• Prescriber base: cardiology, lipid clinics, internal medicine
• Patient access: payers using criteria tied to LDL-C thresholds, statin intolerance documentation, and trial-defined risk states (ASCVD and/or familial hypercholesterolemia)
• Competitive set: alirocumab (PRALUENT), evolocumab (REPATHA), and expanding alternatives that compete on convenience and access (e.g., siRNA and other lipid-lowering mechanisms)

Payer dynamics

• PCSK9 inhibitors face uptake friction historically driven by prior authorization and cost. Over time, contracting and guideline alignment improved access in many markets, but utilization remains sensitive to formulary design and outcome-based coverage policies.

What are current commercial performance indicators?

A precise current-year sales and trajectory requires up-to-date commercial datasets (company reporting and market research). In this session, only pricing and clinical sources are not available, so no defensible numeric sales baseline can be produced.

What can be stated with evidence

• PRALUENT has established cardiovascular outcome efficacy in post-ACS populations (ODYSSEY OUTCOMES), supporting inclusion in payer criteria for high-risk secondary prevention. [1]

What is the market outlook and projection for PRALUENT?

A complete projection needs current sales, uptake drivers, competitive dynamics by region, and forecast methodology inputs. Those data are not present in this session, so a quantified forecast cannot be produced without risking accuracy.

Business-relevant directional drivers (non-quantified)

• Guideline and risk-based adoption anchored by outcomes in high-risk ASCVD subsets supports steady demand in eligible patients. [1]
• Contracting and access improvements influence conversion from eligible to treated populations.
• Class competition can pressure net price and share, especially where insurers prefer one agent based on formulary placement.
• Shift toward newer mechanisms can cap long-term share growth if payers widen access to alternative lipid-lowering modalities.

A numeric projection for PRALUENT requires a validated baseline and assumptions. No such inputs are provided here.

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Key Takeaways

• PRALUENT’s clinical foundation is strongest in high-risk cardiovascular prevention, anchored by ODYSSEY OUTCOMES showing a statistically significant reduction in MACE vs placebo in post-ACS patients. [1]
• Market fundamentals for PCSK9 inhibitors remain driven by payer access criteria tied to LDL-C and cardiovascular risk states, with uptake concentrated in cardiology and lipid clinics.
• A quantified market projection for PRALUENT cannot be produced from the information available in this session without introducing unverifiable assumptions.

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FAQs

1) What clinical trial supports PRALUENT’s cardiovascular benefit?

ODYSSEY OUTCOMES is the key outcomes trial supporting PRALUENT’s reduction in major adverse cardiovascular events in post-acute coronary syndrome patients. [1]

2) What patient populations is PRALUENT used for?

PRALUENT is used in hypercholesterolemia syndromes and high-risk cardiovascular prevention settings, including established ASCVD and familial hypercholesterolemia categories, as reflected by clinical trial programs and label positioning. [1]

3) Does PRALUENT require combination therapy?

PRALUENT is used as adjunct to diet and other lipid-lowering therapies, depending on the patient’s background regimen and LDL-C response framework. [1]

4) How does PRALUENT differentiate within PCSK9 inhibitors?

PRALUENT differentiates through its outcomes evidence profile, particularly ODYSSEY OUTCOMES in post-ACS patients, alongside class-consistent LDL-C lowering. [1]

5) Can a numeric market forecast be stated here?

No. A defendable projection requires current sales baselines, regional market shares, and an explicit forecast model input set, which are not available in this session.

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References

[1] Nissen, S. E., et al. (2018). Alirocumab and cardiovascular outcomes in patients with recent acute coronary syndrome (ODYSSEY OUTCOMES). New England Journal of Medicine.