> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/inclisiran-260e84bb-7090-441d-a494-adb1a029049a > Record changed: 2026-11-04 # Inclisiran Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990033) Drug type Oligonucleotide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990033) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990033) ## Names and chemistry **Drug type** Oligonucleotide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990033) **Drug name** Inclisiran Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990033) ### Other names (22) - aln 60212 - aln pcssc - aln pscsc - ALN-60212 - ALN-PCSSC - ALN-PSCsc - inclisiran - Inclisiran - inclisiran \[INN\] - Inclisiran \[MI\] - INCLISIRAN \[USAN\] - Inclisiran \[WHO-DD\] - inclisiran inn - inclisiran mi - inclisiran usan - inclisiran who dd - kjx 839 - KJX-839 - kjx839 - KJX839 - leqvio - Leqvio ## Identifiers **CAS registry numbers** - 1639324-58-5 **ChEMBL ID** CHEMBL3990033 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990033) **RxNorm IDs (RxCUI)** - 2588243 **FDA ingredient codes (UNII)** - UOW2C71PG5 ### ATC classification codes (2) - C10AX - C10AX16 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3990033) ## Regulatory information ### European Union **Status** Authorised **Status date** 9 Dec 2020 **Authorisation date** 9 Dec 2020 **Approved indications** Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. **Product number** EMEA/H/C/005333 **Authorisation holder** Novartis Europharm Limited **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Dyslipidemias - Hypercholesterolemia European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/leqvio) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No ## Approval status **European Union (EMA)** Authorised ## Pharmacology ### Drug classification **Pharmacology name** inclisiran **Type** Nucleic acid **Approval recorded by Guide to Pharmacology** Yes ### 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 (9) - **Condition** Cardiovascular Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0000319 **Subject identifier** D002318 - **Condition** Coronary Disease **Highest recorded phase** 3 **Condition identifier** EFO:0001645 **Subject identifier** D003327 - **Condition** Kidney Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Atherosclerosis **Highest recorded phase** 3 **Condition identifier** EFO:0003914 **Subject identifier** D050197 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 3 **Condition identifier** EFO:0004911 **Subject identifier** D006938 - **Condition** Acute Coronary Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:0005672 **Subject identifier** D054058 - **Condition** Hypercholesterolemia **Highest recorded phase** 3 **Condition identifier** HP:0003124 **Subject identifier** D006937 - **Condition** Hyperlipoproteinemia Type II **Highest recorded phase** 3 **Condition identifier** MONDO:0018328 **Subject identifier** D006938 - **Condition** Hyperlipidemias **Highest recorded phase** 1 **Condition identifier** MONDO:0021187 **Subject identifier** D006949 ### Open Targets indications (23) - **Condition identifier** EFO\_0000319 - **Condition identifier** EFO\_0001645 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003914 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004911 - **Condition identifier** EFO\_0005672 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008585 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008586 **Highest recorded phase** 3 - **Condition identifier** HP\_0003124 - **Condition identifier** HP\_0003124 **Highest recorded phase** 3 - **Condition identifier** HP\_0003124 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0002525 - **Condition identifier** MONDO\_0002525 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004995 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005010 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005015 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005068 - **Condition identifier** MONDO\_0005240 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005311 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005439 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005542 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0018328 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0021187 **Highest recorded phase** 1 ### Reported adverse events (10) - **Event** hypertriglyceridaemia **Reports** 5 **Reporting signal score** 26.9209 - **Event** ischaemic nephropathy **Reports** 2 **Reporting signal score** 18.2026 - **Event** leriche syndrome **Reports** 2 **Reporting signal score** 18.0543 - **Event** myalgia **Reports** 6 **Reporting signal score** 16.7043 - **Event** myopathy **Reports** 6 **Reporting signal score** 31.818 - **Event** peripheral arterial occlusive disease **Reports** 3 **Reporting signal score** 16.6316 - **Event** peripheral artery bypass **Reports** 2 **Reporting signal score** 17.1055 - **Event** spleen ischaemia **Reports** 2 **Reporting signal score** 23.3324 - **Event** therapeutic product effect incomplete **Reports** 5 **Reporting signal score** 19.8641 - **Event** ulnar nerve injury **Reports** 2 **Reporting signal score** 16.0574 ### Trial references (20) - NCT02314442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02314442) - NCT04765657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04765657) - NCT05763875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05763875) - NCT02963311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02963311) - NCT03851705 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03851705) - NCT05682378 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682378) - NCT03159416 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03159416) - NCT03397121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03397121) - NCT04652726 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04652726) - NCT04659863 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04659863) - NCT03399370 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03399370) - NCT03400800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03400800) - NCT03705234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03705234) - NCT04929249 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04929249) - NCT04774003 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04774003) - NCT04807400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04807400) - NCT05030428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) - NCT05739383 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) - NCT04873934 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04873934) - NCT05360446 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05360446) ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences - **Component** Sequence **Type** Nucleic Acid **Sequence** (3'-5')C=U=A-G-A-C-CX-U-GX-U-T-U-U-G-C-U-U-U-U-G-U-R1$(5'-3')A=A=G-A-U-CX-U-GX-G-AX-C-AX-A-AX-A-CX-G-AX-AX-AX-A=CX=A ## Related records ### Trials (44) - A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia - A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C) - 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) - A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease - A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH) - A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7) - [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 Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia - A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia - An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol - [Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation](https://trialight.com/data/trial/assessment-of-safety-tolerability-pharmacokinetics-and-1f3654b9-13c2-4a2d-8ca0-284e1a4344ad.md) - Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia - Comparing Inclisiran Versus Statin for Primary Aldosteronism - Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease - Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention - Early Intensive Lipid-Lowering With Inclisiran for Plaque Stabilization in Acute Coronary Syndrome - Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound - Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol. - Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. - Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes ### Approved for (1) - [Inherited lipid metabolism disorder](https://trialight.com/data/condition/inherited-lipid-metabolism-disorder-37fa2264-1fbc-5478-9987-67169bc5aaae.md) ### In development for (9) - [Acute coronary syndrome](https://trialight.com/data/condition/acute-coronary-syndrome-3d7c2c1f-86ca-5a25-913a-6f9a7e95f989.md) Phase 3 - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) Phase 3 - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Phase 3 - [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Phase 3 - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) Phase 3 - [Familial hypercholesterolemia](https://trialight.com/data/condition/familial-hypercholesterolemia-ee6bd6b4-71cd-509a-9360-eb8a7c2bd428.md) Phase 3 - Homozygous familial hypercholesterolemia Phase 3 - [Hyperlipidemia](https://trialight.com/data/condition/hyperlipidemia-bd121998-6952-5bac-beaa-6b00584851e2.md) Phase 1 - [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 1 ### Other linked conditions (1) - [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.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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