Primary completion· ClinicalTrials.gov
Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical
Inclisiran History and Updates
175 events · 2017 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
8
FDA Approvals
0
Label Revisions
165
Trial Milestones
2
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-18Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Inclisiran since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (11)
2026
- Results postedInclisiran Significantly Reduces LDL-C in Hypercholesterolemia, Lowers Muscle…· Apr 14, 2026
- FDA approval (supplemental)FDA Approves Supplemental Efficacy Application for Inclisiran (Leqvio)· Feb 12, 2026
- FDA approval (supplemental)Leqvio (inclisiran) Receives FDA Supplemental Efficacy Approval· Feb 12, 2026
2025
- Results postedInclisiran Shows Significant LDL-C Reduction in Acute Coronary Syndrome· Aug 21, 2025
- Results postedInclisiran Monotherapy Reduces LDL-C by 46.5% in Primary Hypercholesterolemia· Aug 13, 2025
- FDA approval (supplemental)Leqvio (Inclisiran) Receives FDA Supplemental Approval for Efficacy· Jul 31, 2025
- Results postedInclisiran for Heterozygous Familial Hypercholesterolemia Shows Significant…· Jun 10, 2025
- Results postedInclisiran Phase 3 Trial for Adolescent HoFH Shows LDL-C Reduction· May 31, 2025
- Results postedInclisiran Monotherapy Reduces LDL-C by 45.87% in Chinese Adults· Apr 20, 2025
2022
- Pivotal publicationInclisiran Trial Results Published for Heterozygous Familial…· Jan 1, 2022
2020
- Pivotal publicationInclisiran Phase 3 Trials for Elevated LDL Cholesterol Results Published· Jan 1, 2020
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Primary completion· ClinicalTrials.gov
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic P
Primary completion· ClinicalTrials.gov
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
Primary completion· ClinicalTrials.gov
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
Primary completion· ClinicalTrials.gov
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
Primary completion· ClinicalTrials.gov
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hyperch
Primary completion· ClinicalTrials.gov
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Primary completion· ClinicalTrials.gov
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
Primary completion· ClinicalTrials.gov
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Primary completion· ClinicalTrials.gov
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Primary completion· ClinicalTrials.gov
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Primary completion· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
Primary completion· ClinicalTrials.gov
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
Primary completion· ClinicalTrials.gov
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary completion· ClinicalTrials.gov
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary In
Primary completion· ClinicalTrials.gov
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION
Primary completion· ClinicalTrials.gov
The Prevent Coronary Artery Disease Trial
Past events
2026
Trial started· ClinicalTrials.gov
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hyperch
Trial started· ClinicalTrials.gov
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
Trial registered· ClinicalTrials.gov
Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hyperch
Trial registered· ClinicalTrials.gov
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
Primary completion· ClinicalTrials.gov
Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
Results posted· ClinicalTrials.gov
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipi
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
FDA approval (supplemental)· FDA
Sponsor: NOVARTIS. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: NOVARTIS. Class: Efficacy.
Primary completion· ClinicalTrials.gov
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Primary completion· ClinicalTrials.gov
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed
2025
Primary completion· ClinicalTrials.gov
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular D
Trial started· ClinicalTrials.gov
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
Primary completion· ClinicalTrials.gov
PET Imaging of Inflammation and Lipid Lowering Study
Primary completion· ClinicalTrials.gov
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
Results posted· ClinicalTrials.gov
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrom
Results posted· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Trial registered· ClinicalTrials.gov
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
FDA approval (supplemental)· FDA
Sponsor: NOVARTIS. Class: Efficacy.
Trial started· ClinicalTrials.gov
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary In
Primary completion· ClinicalTrials.gov
Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
Trial started· ClinicalTrials.gov
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Results posted· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
Primary completion· ClinicalTrials.gov
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
Results posted· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
Trial started· ClinicalTrials.gov
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Trial registered· ClinicalTrials.gov
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
Results posted· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Chol
Trial started· ClinicalTrials.gov
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Trial registered· ClinicalTrials.gov
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary In
Trial started· ClinicalTrials.gov
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Trial registered· ClinicalTrials.gov
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Trial registered· ClinicalTrials.gov
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
Trial started· ClinicalTrials.gov
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
Trial registered· ClinicalTrials.gov
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Primary completion· ClinicalTrials.gov
Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
2024
Trial started· ClinicalTrials.gov
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
Trial started· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
Trial started· ClinicalTrials.gov
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
Trial started· ClinicalTrials.gov
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed
Trial started· ClinicalTrials.gov
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
Trial registered· ClinicalTrials.gov
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
Trial registered· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
Results posted· ClinicalTrials.gov
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atheroscl
Trial registered· ClinicalTrials.gov
Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
Trial started· ClinicalTrials.gov
The Prevent Coronary Artery Disease Trial
Primary completion· ClinicalTrials.gov
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrom
Trial registered· ClinicalTrials.gov
The Prevent Coronary Artery Disease Trial
Trial started· ClinicalTrials.gov
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
Trial started· ClinicalTrials.gov
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular D
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Primary completion· ClinicalTrials.gov
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipi
FDA approval (supplemental)· FDA
Sponsor: NOVARTIS. Class: Labeling.
Trial started· ClinicalTrials.gov
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
Primary completion· ClinicalTrials.gov
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
Trial registered· ClinicalTrials.gov
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular D
Trial registered· ClinicalTrials.gov
Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
Trial registered· ClinicalTrials.gov
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed
Trial registered· ClinicalTrials.gov
Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Chol
Trial started· ClinicalTrials.gov
Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
Trial registered· ClinicalTrials.gov
Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
Results posted· ClinicalTrials.gov
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
Trial started· ClinicalTrials.gov
Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
Results posted· ClinicalTrials.gov
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
Trial started· ClinicalTrials.gov
Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
Primary completion· ClinicalTrials.gov
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
Trial registered· ClinicalTrials.gov
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
Trial registered· ClinicalTrials.gov
Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
Trial registered· ClinicalTrials.gov
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
2023
Primary completion· ClinicalTrials.gov
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Diseas
Primary completion· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
Trial started· ClinicalTrials.gov
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Diseas
Primary completion· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
Primary completion· ClinicalTrials.gov
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atheroscl
Trial registered· ClinicalTrials.gov
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Diseas
Trial started· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Chol
FDA approval (supplemental)· FDA
Sponsor: NOVARTIS. Class: Labeling.
Trial registered· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Chol
Results posted· ClinicalTrials.gov
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Results posted· ClinicalTrials.gov
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
Trial started· ClinicalTrials.gov
PET Imaging of Inflammation and Lipid Lowering Study
Trial started· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Trial registered· ClinicalTrials.gov
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Trial started· ClinicalTrials.gov
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Trial registered· ClinicalTrials.gov
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary completion· ClinicalTrials.gov
Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques
FDA approval (supplemental)· FDA
Sponsor: NOVARTIS. Class: Labeling.
Primary completion· ClinicalTrials.gov
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
Trial started· ClinicalTrials.gov
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION
Primary completion· ClinicalTrials.gov
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
Trial registered· ClinicalTrials.gov
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION
2022
Trial registered· ClinicalTrials.gov
Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques
Results posted· ClinicalTrials.gov
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Trial started· ClinicalTrials.gov
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
Trial registered· ClinicalTrials.gov
Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
Trial started· ClinicalTrials.gov
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic P
Trial started· ClinicalTrials.gov
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
Primary completion· ClinicalTrials.gov
Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and
FDA approval (supplemental)· FDA
Sponsor: NOVARTIS. Class: Labeling.
Trial registered· ClinicalTrials.gov
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic P
Primary completion· ClinicalTrials.gov
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Trial started· ClinicalTrials.gov
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipi
Trial registered· ClinicalTrials.gov
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipi
Pivotal publication· PubMed
ORION-9 — Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
2021
FDA approval· FDA
Sponsor: NOVARTIS. Class: Type 1 - New Molecular Entity.
Primary completion· ClinicalTrials.gov
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
Trial started· ClinicalTrials.gov
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Primary completion· ClinicalTrials.gov
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
Trial registered· ClinicalTrials.gov
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
Trial registered· ClinicalTrials.gov
Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
Trial started· ClinicalTrials.gov
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
Trial started· ClinicalTrials.gov
Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques
Trial started· ClinicalTrials.gov
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atheroscl
Trial started· ClinicalTrials.gov
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrom
Trial registered· ClinicalTrials.gov
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atheroscl
Trial registered· ClinicalTrials.gov
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrom
Trial registered· ClinicalTrials.gov
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
Trial started· ClinicalTrials.gov
Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and
Trial registered· ClinicalTrials.gov
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
Trial started· ClinicalTrials.gov
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
Trial registered· ClinicalTrials.gov
Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and
Trial started· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
Trial started· ClinicalTrials.gov
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Trial started· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
2020
Trial registered· ClinicalTrials.gov
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Trial registered· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
Trial registered· ClinicalTrials.gov
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
Results posted· ClinicalTrials.gov
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial H
Results posted· ClinicalTrials.gov
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Results posted· ClinicalTrials.gov
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
Primary completion· ClinicalTrials.gov
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Pivotal publication· PubMed
ORION-11 — Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
2019
Primary completion· ClinicalTrials.gov
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Trial registered· ClinicalTrials.gov
PET Imaging of Inflammation and Lipid Lowering Study
Primary completion· ClinicalTrials.gov
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial H
Primary completion· ClinicalTrials.gov
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
Trial started· ClinicalTrials.gov
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
Trial registered· ClinicalTrials.gov
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Trial started· ClinicalTrials.gov
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Trial registered· ClinicalTrials.gov
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
2018
Trial started· ClinicalTrials.gov
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
Trial registered· ClinicalTrials.gov
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
Primary completion· ClinicalTrials.gov
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
Trial registered· ClinicalTrials.gov
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
Trial registered· ClinicalTrials.gov
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Trial registered· ClinicalTrials.gov
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial H
2017
Trial started· ClinicalTrials.gov
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Trial started· ClinicalTrials.gov
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial H
Trial started· ClinicalTrials.gov
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
Trial started· ClinicalTrials.gov
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
Trial registered· ClinicalTrials.gov
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
Trial started· ClinicalTrials.gov
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
Trial registered· ClinicalTrials.gov
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.