CLINICAL TRIALS PROFILE FOR INCLISIRAN SODIUM

All Clinical Trials for inclisiran sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03397121 ↗	Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)	Completed	The Medicines Company	Phase 3	2017-11-28	This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
NCT03399370 ↗	Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol	Completed	The Medicines Company	Phase 3	2017-12-21	This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.
NCT03400800 ↗	Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol	Completed	The Medicines Company	Phase 3	2017-11-01	This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).
NCT03705234 ↗	A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease	Recruiting	Novartis Pharmaceuticals	Phase 3	2018-10-30	ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.
NCT03705234 ↗	A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease	Recruiting	The Medicines Company	Phase 3	2018-10-30	ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.
NCT03705234 ↗	A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease	Recruiting	The TIMI Study Group	Phase 3	2018-10-30	ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.

Clinical Trial Conditions for inclisiran sodium

Condition Name

Condition Name for inclisiran sodium
Intervention	Trials
Elevated Cholesterol	4
Hypercholesterolemia	4
ASCVD	3
Atherosclerotic Cardiovascular Disease	3

Condition MeSH

Condition MeSH for inclisiran sodium
Intervention	Trials
Hypercholesterolemia	9
Atherosclerosis	6
Cardiovascular Diseases	5
Hyperlipoproteinemia Type II	3

Clinical Trial Locations for inclisiran sodium

Trials by Country

Trials by Country for inclisiran sodium
Location	Trials
United States	69
Japan	15
United Kingdom	12
China	11
South Africa	10

Trials by US State

Trials by US State for inclisiran sodium
Location	Trials
Ohio	3
New Jersey	3
Nevada	3
Minnesota	3
Georgia	3

Clinical Trial Progress for inclisiran sodium

Clinical Trial Phase

Clinical Trial Phase for inclisiran sodium
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	11
Phase 2	1

Clinical Trial Status

Clinical Trial Status for inclisiran sodium
Clinical Trial Phase	Trials
Not yet recruiting	5
Recruiting	3
Completed	3

Clinical Trial Sponsors for inclisiran sodium

Sponsor Name

Sponsor Name for inclisiran sodium
Sponsor	Trials
Novartis Pharmaceuticals	10
The Medicines Company	5
The TIMI Study Group	1

Sponsor Type

Sponsor Type for inclisiran sodium
Sponsor	Trials
Industry	15
Other	2

Inclisiran Sodium: Clinical Trials Update, Market Analysis, and Projections

Introduction to Inclisiran Sodium

Inclisiran sodium, a small interfering RNA (siRNA) therapy, has been at the forefront of innovative treatments for lowering low-density lipoprotein cholesterol (LDL-C) levels. Developed by Novartis, this drug targets the PCSK9 gene, which is involved in the regulation of LDL-C. Here, we will delve into the recent clinical trials, market analysis, and future projections for inclisiran sodium.

Clinical Trials Overview

ORION-5 Study

The ORION-5 study is a pivotal trial that evaluated the efficacy, safety, and tolerability of inclisiran in patients with homozygous familial hypercholesterolemia (HoFH). This two-part study consisted of a 6-month double-blind placebo-controlled phase followed by an 18-month open-label single-arm phase. Despite significant reductions in PCSK9 levels, inclisiran did not lower LDL-C levels in these patients, highlighting the complexity of treating HoFH[1][4].

Cardiovascular Event Reduction

In another significant study, inclisiran was shown to reduce major adverse cardiovascular events (MACE) when used in combination with diet and maximally tolerated statins. The study involved 3655 patients and demonstrated a 50.6% placebo-corrected reduction in LDL-C levels at Day 90. Inclisiran significantly reduced composite MACE, although it did not individually reduce fatal and non-fatal myocardial infarctions or strokes[2].

Ongoing Trials

The CKJX839D12302 study is a Phase III trial designed to evaluate whether inclisiran can reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) in patients at high cardiovascular risk without prior major atherosclerotic cardiovascular disease (ASCVD) events. This study will provide further insights into the drug's efficacy in preventing cardiovascular events[5].

Safety and Tolerability

Anti-Drug Antibodies

Studies have shown that inclisiran does not induce the formation of anti-drug antibodies (ADA), which is a significant safety advantage. This was confirmed in a pilot study where none of the subjects developed ADA against inclisiran[4].

Hypersensitivity Reactions

The clinical trials have also monitored for potential anaphylactic/hypersensitivity reactions, new onset of diabetes, and worsening of glycemic control. So far, the data suggest that inclisiran is well-tolerated with minimal adverse effects[4].

Market Analysis

Current Market Position

Inclisiran has been approved for use in patients with primary hypercholesterolemia in combination with diet and maximally tolerated statins. Its unique mechanism of action and twice-yearly dosing regimen make it an attractive option for patients who struggle with daily or weekly treatments.

Market Growth

Novartis has reported significant growth in the sales of inclisiran, driven by volume increases in the US and other geographies. The drug's market performance is expected to continue growing as more patients and healthcare providers become aware of its benefits[3].

Market Projections

Demand-Driven Growth

The demand for inclisiran is expected to rise due to its efficacy in reducing LDL-C levels and the associated cardiovascular risk. With ongoing trials aiming to expand its indications, the market potential for inclisiran is substantial.

Competitive Landscape

Inclisiran operates in a competitive landscape dominated by statins and other lipid-lowering therapies. However, its unique siRNA mechanism and less frequent dosing schedule position it as a preferred choice for many patients and healthcare providers.

Geographic Expansion

Novartis is expanding the availability of inclisiran across various geographies, including the US, EU, and China. This geographic expansion is expected to drive further growth and increase the drug's global market share[3].

Key Takeaways

• Clinical Efficacy: Inclisiran significantly reduces LDL-C levels and composite MACE in patients with primary hypercholesterolemia.
• Safety Profile: The drug is well-tolerated with no induction of anti-drug antibodies and minimal adverse effects.
• Market Growth: Inclisiran is experiencing strong sales growth driven by volume increases in key markets.
• Future Projections: The drug is expected to continue growing as it expands into new indications and geographies.

FAQs

What is inclisiran sodium used for?

Inclisiran sodium is used to lower LDL-C levels in patients with primary hypercholesterolemia, often in combination with diet and maximally tolerated statins.

How is inclisiran administered?

Inclisiran is administered subcutaneously, typically at a dose of 300 mg (equivalent to 284 mg of inclisiran) on Day 1, Day 90, and every 6 months thereafter.

What are the main findings from the ORION-5 study?

The ORION-5 study found that inclisiran did not reduce LDL-C levels in patients with homozygous familial hypercholesterolemia despite lowering PCSK9 levels significantly.

Does inclisiran induce anti-drug antibodies?

No, studies have shown that inclisiran does not induce the formation of anti-drug antibodies.

What are the future market projections for inclisiran?

Inclisiran is expected to continue growing due to its efficacy, unique dosing regimen, and expanding indications and geographic availability.

Sources

1. Efficacy, Safety, and Tolerability of Inclisiran in Patients With Homozygous Familial Hypercholesterolemia. Circulation, 2023.
2. Inclisiran and Cardiovascular Events: A Patient-Level Analysis. European Heart Journal, 2022.
3. Novartis Q2 2024 Investor Presentation. Novartis, 2024.
4. ClinicalTrials.gov: A Two-Part Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia.
5. ClinicalTrials.gov: A Study of Inclisiran to Prevent Cardiovascular Events in High-Risk Patients.