Inclisiran

Summary

Inclisiran (CHEMBL3990033) is a phase-3 clinical-stage oligonucleotide (ATC C10AX16); indicated across 9 conditions including cardiovascular disorder and familial hypercholesterolemia.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Oligonucleotide
• ATC class: C10AX16
• Indications: 9 conditions
• Clinical trials: 46

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3990033
Name	Inclisiran
Type	Oligonucleotide
Max phase	3
ATC	C10AX16

Also known as: ALN-60212, ALN-PCSSC, ALN-PSCsc, Inclisiran, Leqvio, INCLISIRAN

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

7 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
cardiovascular disorder	3	MONDO:0004995	EFO:0000319
familial hypercholesterolemia	3	MONDO:0005439	EFO:0004911
acute coronary syndrome	3	MONDO:0005542	EFO:0005672
coronary artery disorder	3	MONDO:0005010	EFO:0001645
atherosclerosis	3	MONDO:0005311	EFO:0003914
kidney disorder	1	MONDO:0005240	EFO:0003086
hyperlipidemia	1	MONDO:0021187	MONDO:0021187

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 46.

Phase distribution

Phase	Trials
PHASE3	18
Not specified	13
PHASE4	8
PHASE2	4
PHASE1	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06249165	PHASE4	ACTIVE_NOT_RECRUITING	VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
NCT06372925	PHASE4	RECRUITING	Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction
NCT06421363	PHASE4	NOT_YET_RECRUITING	Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
NCT06586684	PHASE4	NOT_YET_RECRUITING	Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound
NCT06941792	PHASE4	ACTIVE_NOT_RECRUITING	Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
NCT07581808	PHASE4	NOT_YET_RECRUITING	Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
NCT06280976	PHASE4	WITHDRAWN	Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
NCT06386419	PHASE4	COMPLETED	A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT03705234	PHASE3	ACTIVE_NOT_RECRUITING	A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
NCT05030428	PHASE3	ACTIVE_NOT_RECRUITING	Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
NCT05360446	PHASE3	ACTIVE_NOT_RECRUITING	Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
NCT05682378	PHASE3	RECRUITING	Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
NCT06494501	PHASE3	RECRUITING	The Prevent Coronary Artery Disease Trial
NCT06597006	PHASE3	RECRUITING	Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
NCT06597019	PHASE3	RECRUITING	Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
NCT06813911	PHASE3	RECRUITING	Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
NCT07102628	PHASE3	RECRUITING	Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
NCT03397121	PHASE3	COMPLETED	Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
NCT04652726	PHASE3	COMPLETED	Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
NCT04659863	PHASE3	COMPLETED	Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
NCT04807400	PHASE3	COMPLETED	Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
NCT04873934	PHASE3	COMPLETED	Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
NCT04929249	PHASE3	COMPLETED	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)
NCT05004675	PHASE3	COMPLETED	Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
NCT05763875	PHASE3	COMPLETED	Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
NCT05888103	PHASE3	COMPLETED	Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
NCT07610278	PHASE2	NOT_YET_RECRUITING	A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
NCT02597127	PHASE2	COMPLETED	Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
NCT02963311	PHASE2	COMPLETED	A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
NCT03060577	PHASE2	COMPLETED	An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
NCT02314442	PHASE1	COMPLETED	A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C)
NCT03159416	PHASE1	COMPLETED	A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)
NCT04774003	PHASE1	COMPLETED	Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
NCT04073797	Not specified	RECRUITING	PET Imaging of Inflammation and Lipid Lowering Study
NCT05399992	Not specified	ACTIVE_NOT_RECRUITING	Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
NCT05587621	Not specified	NOT_YET_RECRUITING	Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
NCT05726838	Not specified	ACTIVE_NOT_RECRUITING	The Belgian REAL (BE.REAL) Registry
NCT06275724	Not specified	ACTIVE_NOT_RECRUITING	Specified Drug-use Survey of Leqvio for s.c. Injection.
NCT06287177	Not specified	RECRUITING	Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
NCT06770543	Not specified	RECRUITING	Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
NCT06858332	Not specified	RECRUITING	Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
NCT06958315	Not specified	RECRUITING	Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
NCT07615166	Not specified	ACTIVE_NOT_RECRUITING	Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practice
NCT05118230	Not specified	COMPLETED	Study to Assess the Real World Effectiveness of Inclisiran in Chinese Adult Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT05362903	Not specified	COMPLETED	A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting
NCT05639218	Not specified	UNKNOWN	Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).