Inclisiran - PharmaKB

Leqvio(inclisiran)

Leqvio (inclisiran) is an oligonucleotide pharmaceutical. Inclisiran was first approved as Leqvio on 2020-12-09. It is used to treat hypercholesterolemia in the USA. It has been approved in Europe to treat dyslipidemias and hypercholesterolemia.

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Drug

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YTD

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750

Trade Name

FDA

EMA

Leqvio

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Inclisiran sodium

Tradename	Company	Number	Date	Products
LEQVIO	Novartis	N-214012 RX	2021-12-22	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
leqvio	New Drug Application	2025-07-31

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hypercholesterolemia	—	D006937	—

Agency Specific

FDA

EMA

Expiration	Code
INCLISIRAN SODIUM, LEQVIO, NOVARTIS
2026-12-22	NCE

Patent Expiration

Patent	Expires	Flag	FDA Information
Inclisiran Sodium, Leqvio, Novartis
10851377	2036-08-25		U-3652
10125369	2034-08-18	DS, DP	U-3652
8106022	2029-12-12	DS, DP	U-3652
8828956	2028-12-04	DS, DP	U-3652
9370582	2028-12-04	DS, DP	U-3652
10806791	2028-12-04	DP
10131907	2028-08-24	DS, DP	U-3652
8222222	2027-12-29		U-3652
8809292	2027-05-10	DS, DP	U-3652
11530408	2024-05-18	DP
9708615	2024-03-08	DP
10273477	2024-03-08	DP
10669544	2024-03-08	DP

ATC Codes

C: Cardiovascular system drugs

— C10: Lipid modifying agents

— C10A: Lipid modifying agents, plain

— C10AX: Other lipid modifying agents in atc

— C10AX16: Inclisiran

HCPCS

Code	Description
J1306	Injection, inclisiran, 1 mg

Clinical

Clinical Trials

68 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypercholesterolemia	D006937	—	—	1	3	15	5	12	36
Atherosclerosis	D050197	EFO_0003914	I25.1	—	2	7	3	10	22
Cardiovascular diseases	D002318	EFO_0000319	I98	—	1	7	3	9	20
Coronary artery disease	D003324	—	I25.1	—	—	3	5	2	10
Dyslipidemias	D050171	—	—	—	—	5	1	2	8
Hyperlipidemias	D006949	EFO_0003774	E78.5	1	—	5	1	—	7
Acute coronary syndrome	D054058	EFO_0005672	—	—	—	2	1	2	5
Myocardial ischemia	D017202	EFO_1001375	I20-I25	—	—	2	2	1	5
Atherosclerotic plaque	D058226	HP_0031678	I70	—	—	1	2	2	5
Coronary disease	D003327	—	—	—	—	2	1	1	4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hyperlipoproteinemia type ii	D006938	EFO_0004911	E78.00	—	4	8	—	5	17
Homozygous familial hypercholesterolemia	D000090542	—	—	—	1	5	—	—	6
Heart failure	D006333	EFO_0003144	I50	—	—	2	—	—	2
Aortic valve stenosis	D001024	EFO_0000266	—	—	—	2	—	—	2
Syndrome	D013577	—	—	—	—	1	—	1	2
Heart disease risk factors	D000082742	—	—	—	—	1	—	—	1
Arterial occlusive diseases	D001157	EFO_0009085	—	—	—	1	—	—	1
Stroke	D020521	EFO_0000712	I63.9	—	—	1	—	—	1
Coronary stenosis	D023921	EFO_1000882	—	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Diabetes mellitus	D003920	EFO_0000400	E08-E13	—	1	—	—	1	2
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Renal insufficiency	D051437	—	N19	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inflammation	D007249	MP_0001845	—	—	—	—	—	1	1
St elevation myocardial infarction	D000072657	—	—	—	—	—	—	1	1
Non-st elevated myocardial infarction	D000072658	—	—	—	—	—	—	1	1
Cerebrovascular disorders	D002561	EFO_0003763	I60-I69	—	—	—	—	1	1
Peripheral arterial disease	D058729	EFO_0004265	—	—	—	—	—	1	1
Peripheral vascular diseases	D016491	EFO_0003875	I73.9	—	—	—	—	1	1
Aortic valve disease	D000082862	—	—	—	—	—	—	1	1
Congenital heart defects	D006330	—	Q24.9	—	—	—	—	1	1
Heart valve diseases	D006349	EFO_0009551	I08	—	—	—	—	1	1
Vascular diseases	D014652	EFO_0004264	I77	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Inclisiran
INN	inclisiran
Description	Inclisiran, sold under the brand name Leqvio, is a medication used for the treatment of high low-density lipoprotein (LDL) cholesterol and for the treatment of people with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk-equivalents, and heterozygous familial hypercholesterolemia (HeFH). It is a small interfering RNA (siRNA) that acts as an inhibitor of a proprotein convertase, specifically, inhibiting translation of the protein PCSK9.
Classification	Oligonucleotide
Drug class	Antilipemic agent
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—