Inclisiran sodium
Highest phase reached
Approved
Drug type
Oligonucleotide
First approval year
2020
- First approval year
- 2020
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Oligonucleotide
- Drug name
- Inclisiran sodium
- leqvio
- Leqvio
- 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
- CAS registry numbers
- 1639324-62-1
- ChEMBL ID
- CHEMBL5095052
- RxNorm IDs (RxCUI)
- 2588259
- FDA ingredient codes (UNII)
- UPC6BTX7PY
- Applicant
- NOVARTIS
- Approval date
- 22 Dec 2021
- Application number
- NDA214012
- 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 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
- 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
- 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
- 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
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 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.
- 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
- 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)
Targets (1)
- PCSK9 PCSK9 mRNA rnai inhibitor