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.
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.
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).
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.
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Inclisiran Sodium: Clinical Trials, Market Analysis, and Projections
Last updated: March 29, 2026
What is the status of clinical development for inclisiran sodium?
Inclisiran sodium is an RNA interference (RNAi) therapeutic approved for lowering LDL cholesterol. It inhibits PCSK9 synthesis in the liver, resulting in increased LDL receptor recycling. The drug's development began with promising Phase 3 trial results, leading to regulatory approvals in several markets.
Clinical Trial Phases and Results
Phase 1: Demonstrated safety and dose-dependent LDL reduction.
Phase 2: Confirmed efficacy in reducing LDL cholesterol by approximately 50% to 60%, with sustained effects over several months.
Phase 3: ORION program comprising multiple trials, including ORION-9, ORION-10, and ORION-11, enrolled over 4,600 patients. Results showed LDL reductions of approximately 50% sustained with biannual dosing.
Regulatory Status: Approved by the U.S. Food and Drug Administration (FDA) in December 2020 under the brand name Leqvio. Approved in Europe by EMA in December 2020.
Ongoing Trials and Future Development
Trials evaluating efficacy in specific populations, such as familial hypercholesterolemia and statin-intolerant patients.
Long-term safety studies are ongoing.
Additional indications, including secondary prevention of cardiovascular events, are under investigation.
How does the market for inclisiran sodium compare to competing therapies?
Market Landscape
Traditional therapies: Statins dominate LDL management but have limitations in responders or intolerant patients.
Other PCSK9 inhibitors: Monoclonal antibodies alirocumab and evolocumab generate annual revenues exceeding $3 billion each but require biweekly or monthly injections.
RNAi therapies: Inclisiran's biannual dosing offers an advantage over monoclonal antibodies for some patient segments.
Market Size and Growth
Parameter
Data
Global hypercholesterolemia market
Estimated at $13 billion in 2022 (GlobalData).
PCSK9 inhibitor market share
Expected to reach $5 billion by 2025 (Fitch Ratings).
Inclisiran market penetration
Projected to reach $2 billion by 2027 (EvaluatePharma).
Competitive Advantages
Dosing schedule: Twice a year compared to monthly or biweekly monoclonal antibodies.
Long-lasting LDL reduction: Sustained over months post-administration.
Potential for broader patient adherence and compliance.
Pricing and Reimbursement
U.S.: List price around $3,500 per dose.
Europe: Pricing varies but generally comparable on a per-dose basis.
Reimbursement policies differ by country, influencing uptake rates.
What are the projections for inclisiran sodium's market growth?
Revenue Forecasts
2023-2025: Compound annual growth rate (CAGR) around 20%, driven by increasing adoption.
2026-2030: Growth slows slightly, stabilization expected as competition intensifies; projected revenues could approach $2.5 billion globally.
Key Drivers
Expanding indications, including primary hyperlipidemia.
Increased awareness and physician adoption, especially with growing data on cardiovascular outcomes.
Cost-effectiveness compared to existing PCSK9 inhibitors may improve access.
Risks and Barriers
High drug price may limit adoption.
Reimbursement constraints in emerging markets.
Competition from new RNAi or gene-editing treatments.
Key Takeaways
Inclisiran sodium has completed Phase 3 trials with positive efficacy and safety profiles; approved in the U.S. and Europe.
It offers a biannual dosing schedule, creating a competitive advantage over monoclonal antibody PCSK9 inhibitors.
Market penetration is strong but faces competition from established therapies; total revenues could reach $2.5 billion globally by 2030.
Ongoing trials will expand indications and reinforce long-term safety data, supporting market growth.
Pricing and reimbursement strategies will influence adoption rates and revenue potential.
FAQs
What is the primary benefit of inclisiran sodium over existing lipid-lowering therapies?
Its infrequent dosing schedule (twice a year) improves patient compliance compared to monthly or weekly injections of monoclonal antibodies.
Are there any significant safety concerns associated with inclisiran?
Clinical trials report a safety profile comparable to placebo, with no new safety signals identified.
What markets are currently approved for inclisiran sodium?
The U.S., Europe, and Japan hold approvals, with regulatory reviews ongoing in other regions.
How does inclisiran's pricing compare to other PCSK9 inhibitors?
Its price per dose is roughly similar to monotherapy costs of monoclonal antibodies but may offer savings via reduced administration frequency.
What are the main challenges to its market expansion?
Reimbursement policies, physician familiarity, competition, and pricing constraints are primary obstacles.
References
[1] European Medicines Agency. (2020). Leqvio (inclisiran): Marketing Authorization.
[2] U.S. Food and Drug Administration. (2020). Leqvio Approval Announcement.
[3] EvaluatePharma. (2022). Market Forecast Data.
[4] Fitch Ratings. (2021). PCSK9 Inhibitor Market Analysis.
[5] GlobalData. (2022). Hypercholesterolemia Market Report.
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