inclisiran
inclisiran: sourced relationships with 2 companies · 19 clinical trials tracked · 1 FDA decision.
inclisiran evidence translation
What we can confirm
1 FDA record · 19 tracked trials
What it means
What to watch
Prepared research question
What is verified about inclisiran, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence6 indications · 1 study sponsors
Related indications
Study sponsors
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| MEDICINES CO /DE (MDCO) hypercholesterolemia, ASCVD, ASCVD-risk equivalents, familia… | Phase 3 |
| Novartis AG (NVS) Reported 2021-12-22 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (19)showing 10 most recent
Statin, Ezetimibe, and Inclisiran for Plaque Regression in Acute Coronary Syndrome: A Randomized Controlled Trial (SEsiR-ACS Trial)
Primary endpoint: Change in Minimal Fibrous Cap Thickness
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
Primary endpoint: Percent change in LDL-C from baseline at Day 60
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
Primary endpoint: Percent change from baseline of PCSK9 levels
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
Primary endpoint: Percent change in LDL-C
Reduction in Low-Density Lipoprotein Cholesterol With Alirocumab 150 mg as Compared With Inclisiran: Comparative Evaluation Via Target-Trial Emulation and G-Computation
Primary endpoint: Mean Percentage Reduction in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline Over the 60 to 450 Days Follow-up
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Atherosclerotic Cardiovascular Disease (ASCVD), and Elevated LDL-C and Lp(a)
Primary endpoint: Change in log transformed lipoprotein A (Lp(a)) concentration
Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Children (2 to Less Than 12 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol
Primary endpoint: Percentage change in LDL-C from baseline to Day 330 (Year 1)
VictORION-INCLUSION: Evaluating INClisiran as a soLUtion to Improve LDL-C Management and cloSe Care Gaps in an Inclusive ASCVD and ASCVD Risk Equivalent populatiON
Primary endpoint: Achievement of LDL-C targets
Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children (6 to Less Than 12 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL- Cholesterol
Primary endpoint: Percentage change in LDL-C from baseline to Day 330 (Year 1)
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
Primary endpoint: Incidence and type of treatment-emergent adverse events (TEAEs)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with inclisiran?
inclisiran has dated SEC/FDA relationship records for MEDICINES CO /DE, Novartis AG.
How many clinical trials involve inclisiran?
BioSniper tracks 19 clinical trials involving inclisiran.
What is inclisiran's latest FDA decision?
The most recent tracked FDA decision for inclisiran is Approval, dated December 22, 2021.