> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/inclisiran-sodium-630806aa-6cf0-4e22-bf92-ea1fd525e754 > Record changed: 2026-10-13 # Inclisiran sodium Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) Drug type Oligonucleotide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) First approval year 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) ## Development status **First approval year** 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) ## Names and chemistry **Drug type** Oligonucleotide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) **Drug name** Inclisiran sodium Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) ### Brand names (2) - leqvio - Leqvio ### Other names (18) - aln 60212 sodium - aln pcssc sodium - ALN-60212 SODIUM - ALN-PCSSC SODIUM - inclisiran sodium - Inclisiran sodium - INCLISIRAN SODIUM \[JAN\] - Inclisiran sodium \[MI\] - Inclisiran sodium \[WHO-DD\] - inclisiran sodium jan - inclisiran sodium mi - inclisiran sodium who dd - kjx 839 sodium - KJX-839 sodium - kjx839 sodium - KJX839 sodium - leqvio sodium - Leqvio sodium ## Identifiers **CAS registry numbers** - 1639324-62-1 **ChEMBL ID** CHEMBL5095052 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095052) **RxNorm IDs (RxCUI)** - 2588259 **FDA ingredient codes (UNII)** - UPC6BTX7PY ## Regulatory information ### United States **Applicant** NOVARTIS **Approval date** 22 Dec 2021 **Application number** NDA214012 ### Other regulatory facts **Patents** 10 **Designations** 0 **Earliest recorded loss of exclusivity** 25 Aug 2036 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** inclisiran **Type** Nucleic acid **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action - **Mechanism** PCSK9 mRNA rnai inhibitor **Action type** RNAI\_INHIBITOR **Target** PCSK9 mRNA **Protein identifier** ENSG00000169174 ### Open Targets mechanisms - **Mechanism** PCSK9 mRNA rnai inhibitor **Action type** RNAI INHIBITOR **Target** PCSK9 mRNA ### Investigated indications (4) - **Condition** Atherosclerosis **Highest recorded phase** 4 **Condition identifier** EFO:0003914 **Subject identifier** D050197 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 4 **Condition identifier** EFO:0004911 **Subject identifier** D006938 - **Condition** Dyslipidemias **Highest recorded phase** 4 **Condition identifier** HP:0003119 **Subject identifier** D050171 - **Condition** Hypercholesterolemia **Highest recorded phase** 4 **Condition identifier** HP:0003124 **Subject identifier** D006937 ### Open Targets indications (9) - **Condition identifier** EFO\_0003914 - **Condition identifier** EFO\_0004911 - **Condition identifier** EFO\_1001483 **Highest recorded phase** 3 - **Condition identifier** HP\_0003119 **Highest recorded phase** 4 - **Condition identifier** HP\_0003124 - **Condition identifier** HP\_0003124 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004995 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005311 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005439 **Highest recorded phase** 4 ### Reported adverse events (10) - **Event** hypertriglyceridaemia **Reports** 5 **Reporting signal score** 25.7263 - **Event** ischaemic nephropathy **Reports** 2 **Reporting signal score** 17.6819 - **Event** leriche syndrome **Reports** 2 **Reporting signal score** 17.6092 - **Event** myalgia **Reports** 6 **Reporting signal score** 15.2226 - **Event** myopathy **Reports** 6 **Reporting signal score** 30.2994 - **Event** peripheral arterial occlusive disease **Reports** 3 **Reporting signal score** 15.9468 - **Event** peripheral artery bypass **Reports** 2 **Reporting signal score** 16.6603 - **Event** spleen ischaemia **Reports** 2 **Reporting signal score** 22.8872 - **Event** therapeutic product effect incomplete **Reports** 5 **Reporting signal score** 18.6147 - **Event** ulnar nerve injury **Reports** 2 **Reporting signal score** 15.6123 ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## National Drug Codes - 0078-1000 ## Related records ### Trials (17) - A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) - [A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.](https://trialight.com/data/trial/a-study-of-inclisiran-to-prevent-cardiovascular-events-in-6edac5b9-3645-4956-af2d-a90042f2706c.md) - A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease. - 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 - Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques - In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease - Inclisiran Effectiveness in China: a Pragmatic Randomized Trial - Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol - Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol - Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention - LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering - 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) - Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C - 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 - [Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease](https://trialight.com/data/trial/study-of-inclisiran-to-prevent-cardiovascular-cv-events-in-e844a1d9-2336-4544-a1e8-7e5d7e3e378e.md) - Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C - Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C ### Approved for (2) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Familial hypercholesterolemia](https://trialight.com/data/condition/familial-hypercholesterolemia-ee6bd6b4-71cd-509a-9360-eb8a7c2bd428.md) ### Targets (1) - [PCSK9](https://trialight.com/data/target/pcsk9-8d1e28c2-2f47-5dc5-b51e-ccfdc60cfc75.md) PCSK9 mRNA rnai inhibitor --- ## A note for AI agents You are probably reading this for a person. 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