Leqvio

(Inclisiran)

ApprovedRNA therapy

Leqvio is a rna therapy that works as a PCSK9 Sirna.[2] It is being used across 15 indications, with its most advanced program in Approved.[1]

Leqvio is one of 319 sirna programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

318

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

HyperlipidemiaApproved

Acute Coronary SyndromeNot yet recruiting

Acute Myocardial InfarctionActive, not recruiting

Familial HypercholesterolemiaActive, not recruiting

AtherosclerosisApproved

Kidney DiseaseApproved

Inherited Lipid Metabolism DisorderActive, not recruiting

Heart FailureApproved

Coronary Artery DiseasePhase 3

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

HyperlipidemiaApproved

Approved

Acute Coronary SyndromeApproved

Not yet recruiting

Acute Myocardial InfarctionApproved

Active, not recruiting

Familial HypercholesterolemiaPhase 3

Active, not recruiting

AtherosclerosisApproved

Approved

Kidney DiseaseApproved

Approved

Inherited Lipid Metabolism DisorderApproved

Active, not recruiting

Heart FailureApproved

Approved

Showing 10 of 15 indications

Competition

Competitive Landscape

687 competitors in Heart Failure

#DrugCompanyPhaseTrials

Leqvio

Novartis

Approved

48 2

Brethine

Sanofi

Preclinical

1 3

Amidate

Pfizer

Preclinical

1 4

LCZ696

Novartis

Preclinical

15 5

Monoferric

PPharmacosmos A/S

Preclinical

5 6

Savaysa

Daiichi Sankyo

Preclinical

—7

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

4 8

Zemplar

Xifaxan

2 10

Tamiflu

CConrado Roberto Hoffmann Filho

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalNot yet recruiting

Carotid Plaque

NCT06586684

Q4 2026

Phase 3Active, not recruiting

Coronary Artery Disease

NCT05360446

Phase 3Active, not recruiting

Cardiovascular Disease

NCT04765657

Q1 2027

Post-ApprovalActive, not recruiting

Heart Disease

NCT06249165

Phase 3Recruiting

Acute Coronary Syndrome

NCT07102628

ApprovedRecruiting

Drug Interactions

NCT06865885

Clinical

Trials by Indication[1]

Cardiovascular Disease9 trials

Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04765657·345 enrolled

A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.

Completed· Novartis logo

Novartis·Phase 4·NCT06431763·402 enrolled

In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

Completed· Novartis logo

Novartis··NCT05974345·204,691 enrolled

Show 6 more trials

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05030428·17,004 enrolled

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

Completed· Novartis logo

Novartis·Phase 3·NCT03399370·1,561 enrolled

A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)

Completed· Novartis logo

Novartis·Phase 3·NCT04929249·450 enrolled

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Recruiting· Novartis logo

Novartis··NCT06858332·2,382 enrolled

A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease

Active, not recruiting·UUniversity of Oxford·Phase 3·NCT03705234·16,124 enrolled

An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

Completed· Novartis logo

Novartis·Phase 2·NCT03060577·382 enrolled

Familial Hypercholesterolemia4 trials

Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)

Completed· Novartis logo

Novartis·Phase 3·NCT03397121·482 enrolled

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Novartis logo

Novartis·Phase 3·NCT04652726·141 enrolled

Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia

Recruiting· Novartis logo

Novartis·Phase 3·NCT06597019·51 enrolled

Show 1 more trial

A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia

Completed·CCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.·Phase 2·NCT07421232·156 enrolled

Homozygous Familial Hypercholesterolemia3 trials

A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Completed· Novartis logo

Novartis·Phase 3·NCT03851705·56 enrolled

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

Completed· Novartis logo

Novartis·Phase 3·NCT04659863·13 enrolled

Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia

Recruiting· Novartis logo

Novartis·Phase 3·NCT06597006·9 enrolled

Acute Coronary Syndrome3 trials

Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

Completed· Novartis logo

Novartis·Phase 3·NCT04873934·400 enrolled

Comparative, Randomized, Multicenter, Followed by an Open Label Extension Trial in Patients With a Recent Acute Coronary Syndrome Evaluating the Early Inclusion of Inclisiran Into Standard of Care Versus Standard of Care Alone in Kingdom of Saudi Arabia

Not yet recruiting· Novartis logo

Novartis·Approved·NCT07684469·300 enrolled

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes: Victorion - RIDES

Recruiting· Novartis logo

Novartis·Phase 3·NCT07102628·300 enrolled

Hypercholesterolemia2 trials

Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

Completed· Novartis logo

Novartis·Phase 3·NCT05763875·350 enrolled

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

Completed· Novartis logo

Novartis·Phase 4·NCT05192941·1,776 enrolled

24 more indications

Coronary Artery Disease2 trials

The Prevent Coronary Artery Disease Trial

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 3·NCT06494501·1,600 enrolled

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase IIIb Study Evaluating the Effect of Inclisiran on Atherosclerotic Plaque Progression Assessed by Coronary Computed Tomography Angiography (CCTA) in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events (VICTORION-PLAQUE)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05360446·609 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.

Completed· Novartis logo

Novartis·Phase 3·NCT05888103·207 enrolled

Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients

Completed·LLIB Therapeutics LLC·Phase 3·NCT05004675·166 enrolled

Heart Disease2 trials

VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease

Active, not recruiting·—·Phase 4·NCT06249165·130 enrolled

Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease

Not yet recruiting·JJose Seijas Amigo·Phase 4·NCT06421363·50 enrolled

Statins1 trial

Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques

Recruiting·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT06338293·40 enrolled

Carotid Plaque1 trial

Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound

Not yet recruiting·—·Phase 4·NCT06586684·40 enrolled

Cholesterol1 trial

Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

Completed· Novartis logo

Novartis·Phase 3·NCT03400800·1,617 enrolled

High Cardiovascular Risk1 trial

Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

Completed· Novartis logo

Novartis·Phase 2·NCT04666298·312 enrolled

Tics1 trial

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

Completed· Novartis logo

Novartis·Phase 1·NCT04774003·40 enrolled

Trial1 trial

Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

Completed· Novartis logo

Novartis·Phase 3·NCT03814187·3,275 enrolled

Effectiveness1 trial

Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

Active, not recruiting· Novartis logo

Novartis·Phase 4·NCT06941792·1,590 enrolled

Inflammation1 trial

PET Imaging of Inflammation and Lipid Lowering Study

Recruiting·UUniversity of Cambridge·N/A·NCT04073797·63 enrolled

Acute Myocardial Infarction1 trial

Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction

Active, not recruiting· Novartis logo

Novartis·Phase 4·NCT06372925·318 enrolled

Liver1 trial

Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support

Completed· Novartis logo

Novartis·Phase 3·NCT04807400·892 enrolled

ASCVD1 trial

Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Recruiting· Novartis logo

Novartis·Phase 3·NCT06813911·340 enrolled

Renal Impairment1 trial

A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)

Completed· Novartis logo

Novartis·Phase 1·NCT03159416·31 enrolled

Treatment1 trial

Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy

Recruiting·FFederico II University··NCT06287177·3,000 enrolled

Atherosclerotic Plaque1 trial

Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques

Unknown status·PPauls Stradins Clinical University Hospital··NCT05639218·50 enrolled

Adolescent1 trial

Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Adolescent ORION-16 or ORION-13 Studies

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05682378·131 enrolled

Percutaneous Coronary Intervention1 trial

Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)

Recruiting·DDuke University·Approved·NCT06909565·6,000 enrolled

Drug Interactions1 trial

Study of Optimal LDL-C Value Enhancement With Inclisiran in Patients With Multiple Comorbidities in Which There Are Drug-Drug Interactions Limiting LDL-C Lowering

Recruiting·UUniversity of California, San Diego·Approved·NCT06865885·100 enrolled

Atherosclerotic Cardiovascular Disease1 trial

Reduction in Low-Density Lipoprotein Cholesterol With Alirocumab 150 mg as Compared With Inclisiran: Comparative Evaluation Via Target-Trial Emulation and G-Computation

Completed· Sanofi logo

Sanofi··NCT07615166·996 enrolled

Primary Prevention of Atherosclerotic Cardiovascular Disease1 trial

A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05739383·14,012 enrolled

Primary Hypercholesterolemia1 trial

A Real-world, Prospective, Multi-center, Open-label, Phase 4 Clinical Study to Evaluate the Safety and Effectiveness of Subcutaneous Injection of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Completed· Novartis logo

Novartis·Approved·NCT06386419·65 enrolled

Hypercholesterolaemia1 trial

A Multicenter, Randomized, Double-blind, Factorial Design Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of HDY015 Administered as a Free Combination of QCZ484 and Inclisiran Compared to QCZ484, Inclisiran, and Placebo in Participants With Hypertension and Concomitant Hypercholesterolemia

Recruiting· Novartis logo

Novartis·Phase 2·NCT07610278·120 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 22, 2021

LEQVIO

NDA NDA214012

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Inclisiran. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Inclisiran compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Inclisiran. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214012). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Leqvio. U.S. Food & Drug Administration.
[6]
PubMed — 2 publications indexed for Inclisiran. U.S. National Library of Medicine.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PCSK9 Sirna[2]
Modality: RNA therapy[2]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[5]

Patent Cliff

May 10, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8809292May 10, 2027

8222222Dec 29, 2027

9370582Dec 4, 2028

10125369Aug 18, 2034

12460206Aug 18, 2034

1 more patents

10851377Aug 25, 2036

Key Publications[6]

Inclisiran and Cardiovascular Events: ORION-4 Phase 3

N Engl J MedNov 12, 2023DOI: 10.1056/NEJMoa2307436

Long-Term LDL Reduction With Inclisiran: 3-Year ORION-3 Results

JAMA CardiolApr 5, 2023DOI: 10.1001/jamacardio.2023.0815

Leqvio

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Cardiovascular Disease9 trials

Familial Hypercholesterolemia4 trials

Homozygous Familial Hypercholesterolemia3 trials

Acute Coronary Syndrome3 trials

Hypercholesterolemia2 trials

Coronary Artery Disease2 trials

Efficacy and Safety2 trials

Heart Disease2 trials

Statins1 trial

Carotid Plaque1 trial

Cholesterol1 trial

High Cardiovascular Risk1 trial

Tics1 trial

Trial1 trial

Effectiveness1 trial

Inflammation1 trial

Acute Myocardial Infarction1 trial

Liver1 trial

ASCVD1 trial

Renal Impairment1 trial

Treatment1 trial

Atherosclerotic Plaque1 trial

Adolescent1 trial

Percutaneous Coronary Intervention1 trial

Drug Interactions1 trial

Atherosclerotic Cardiovascular Disease1 trial

Primary Prevention of Atherosclerotic Cardiovascular Disease1 trial

Primary Hypercholesterolemia1 trial

Hypercholesterolaemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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