Inclisiran Sodium

Summary

Inclisiran Sodium (CHEMBL5095052) is an approved oligonucleotide; indicated across 4 conditions including atherosclerosis and familial hypercholesterolemia.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Oligonucleotide
• Indications: 4 conditions
• Clinical trials: 11

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5095052
Name	Inclisiran Sodium
Type	Oligonucleotide
Max phase	4

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

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

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
atherosclerosis	4	MONDO:0005311	EFO:0003914
familial hypercholesterolemia	4	MONDO:0005439	EFO:0004911

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

Clinical trials

Total trials: 11.

Phase distribution

Phase	Trials
PHASE3	5
PHASE4	4
PHASE2	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06338293	PHASE4	RECRUITING	Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
NCT05192941	PHASE4	COMPLETED	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
NCT06280976	PHASE4	WITHDRAWN	Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)
NCT06431763	PHASE4	COMPLETED	A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
NCT04765657	PHASE3	ACTIVE_NOT_RECRUITING	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)
NCT03399370	PHASE3	COMPLETED	Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
NCT03400800	PHASE3	COMPLETED	Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
NCT03814187	PHASE3	COMPLETED	Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
NCT03851705	PHASE3	COMPLETED	A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
NCT04666298	PHASE2	COMPLETED	Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
NCT05974345	Not specified	COMPLETED	In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

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).