Inclisiran
Highest phase reached
Phase 3
Drug type
Oligonucleotide
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Oligonucleotide
- Drug name
- Inclisiran
- 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
- CAS registry numbers
- 1639324-58-5
- ChEMBL ID
- CHEMBL3990033
- RxNorm IDs (RxCUI)
- 2588243
- FDA ingredient codes (UNII)
- UOW2C71PG5
- C10AX
- C10AX16
Sources for recorded values
- 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
- 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
- European Union (EMA)
- Authorised
- 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
- 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
- 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
- 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
- NCT02314442
- NCT04765657
- NCT05763875
- NCT02963311
- NCT03851705
- NCT05682378
- NCT03159416
- NCT03397121
- NCT04652726
- NCT04659863
- NCT03399370
- NCT03400800
- NCT03705234
- NCT04929249
- NCT04774003
- NCT04807400
- NCT05030428
- NCT05739383
- NCT04873934
- NCT05360446
- 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.
- 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
- 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)
In development for (9)
- Acute coronary syndrome Phase 3
- Atherosclerosis Phase 3
- Cardiovascular disorder Phase 3
- Coronary artery disorder Phase 3
- Diabetes mellitus Phase 3
- Familial hypercholesterolemia Phase 3
- Homozygous familial hypercholesterolemia Phase 3
- Hyperlipidemia Phase 1
- Kidney disorder Phase 1
Other linked conditions (1)
Targets (1)
- PCSK9 PCSK9 mRNA RNAi inhibitor