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Date	Agency	Company	Orphan
Dec. 9, 2020	EMA	Novartis Europharm Limited
Dec. 22, 2021	FDA	NOVARTIS PHARMS CORP

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Low density lipoprotein increased	610.51	30.24	122	3323	7963	90617039
Myalgia	308.12	30.24	144	3301	174981	90450021
Injection site rash	209.08	30.24	64	3381	24109	90600893
Injection site reaction	162.19	30.24	76	3369	92004	90532998
Injection site erythema	113.45	30.24	61	3384	98441	90526561
Injection site pruritus	93.30	30.24	44	3401	53790	90571212
Injection site pain	88.45	30.24	64	3381	173635	90451367
Blood triglycerides increased	72.28	30.24	25	3420	13736	90611266
Arthralgia	70.39	30.24	114	3331	778408	89846594
Product storage error	66.39	30.24	26	3419	20215	90604787
Peripheral arterial occlusive disease	60.95	30.24	17	3428	4604	90620398
Pain in extremity	46.09	30.24	70	3375	450459	90174543
Immobilisation syndrome	40.81	30.24	8	3437	465	90624537
Apolipoprotein B increased	39.22	30.24	5	3440	14	90624988
Low density lipoprotein abnormal	37.33	30.24	7	3438	321	90624681
Therapy non-responder	37.08	30.24	35	3410	136669	90488333
Rash	34.54	30.24	86	3359	796014	89828988
Fear of death	33.48	30.24	8	3437	1179	90623823
Low density lipoprotein decreased	32.13	30.24	6	3439	269	90624733

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Low density lipoprotein increased	380.71	32.56	85	2793	5270	42613187
Myalgia	302.81	32.56	141	2737	95939	42522518
Leriche syndrome	98.80	32.56	15	2863	98	42618359
Arthralgia	93.26	32.56	90	2788	205148	42413309
Lipoprotein (a) increased	87.72	32.56	16	2862	348	42618109
Spleen ischaemia	66.59	32.56	10	2868	60	42618397
Ischaemic nephropathy	63.23	32.56	10	2868	88	42618369
Blood creatine phosphokinase increased	61.23	32.56	39	2839	48299	42570158
Ulnar nerve injury	61.12	32.56	10	2868	111	42618346
Blood triglycerides increased	58.05	32.56	26	2852	15870	42602587
Peripheral artery bypass	58.01	32.56	9	2869	69	42618388
Myopathy	55.06	32.56	24	2854	13737	42604720
Injection site pain	50.32	32.56	37	2841	57761	42560696
Injection site reaction	48.89	32.56	23	2855	15698	42602759
Low density lipoprotein decreased	47.09	32.56	12	2866	1292	42617165
Drug intolerance	45.51	32.56	40	2838	80384	42538073
Peripheral arterial occlusive disease	44.81	32.56	17	2861	6821	42611636
Low density lipoprotein abnormal	37.35	32.56	8	2870	403	42618054
Low density lipoprotein	36.90	32.56	5	2873	12	42618445
Muscle discomfort	36.02	32.56	7	2871	216	42618241
Myocardial infarction	32.69	32.56	41	2837	123968	42494489

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Low density lipoprotein increased	385.22	27.14	86	3693	10580	110574940
Myalgia	372.62	27.14	171	3608	222210	110363310
Injection site rash	145.51	27.14	47	3732	23372	110562148
Leriche syndrome	103.98	27.14	15	3764	143	110585377
Injection site pain	81.53	27.14	59	3720	177863	110407657
Injection site pruritus	80.86	27.14	38	3741	51220	110534300
Arthralgia	77.92	27.14	113	3666	779519	109806001
Injection site reaction	76.80	27.14	44	3735	89026	110496494
Spleen ischaemia	73.40	27.14	10	3769	60	110585460
Injection site erythema	69.31	27.14	42	3737	94134	110491386
Ischaemic nephropathy	68.88	27.14	10	3769	100	110585420
Blood triglycerides increased	68.33	27.14	27	3752	23899	110561621
Peripheral artery bypass	60.19	27.14	9	3770	112	110585408
Peripheral arterial occlusive disease	59.13	27.14	19	3760	9261	110576259
Ulnar nerve injury	58.99	27.14	10	3769	286	110585234
Acute myocardial infarction	58.15	27.14	36	3743	83741	110501779
Lipoprotein (a) increased	52.36	27.14	8	3771	116	110585404
Blood creatine phosphokinase increased	47.18	27.14	30	3749	73047	110512473
Myocardial infarction	46.47	27.14	44	3735	192039	110393481
Glycosylated haemoglobin increased	45.06	27.14	20	3759	23599	110561921
Low density lipoprotein decreased	38.05	27.14	9	3770	1413	110584107
High density lipoprotein increased	37.76	27.14	9	3770	1460	110584060
Immobilisation syndrome	36.74	27.14	8	3771	868	110584652
Hepatic fibrosis	33.58	27.14	12	3767	8054	110577466
Vascular stent stenosis	32.31	27.14	8	3771	1521	110583999
Apolipoprotein B increased	31.85	27.14	4	3775	11	110585509
Fear of death	31.62	27.14	8	3771	1659	110583861
Lipoprotein increased	30.32	27.14	4	3775	18	110585502
Muscle spasms	28.57	27.14	41	3738	278116	110307404
Peripheral artery occlusion	27.22	27.14	8	3771	2897	110582623

Source	Code	Description
ATC	C10AX16	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Other lipid modifying agents
CHEBI has role	CHEBI:35554	cardiovascular drug
CHEBI has role	CHEBI:35821	anticholesteremic drug
CHEBI has role	CHEBI:145947	antiatherosclerotic agent
CHEBI has role	CHEBI:231911	renoprotective agent

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inclisiran 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products:

Disease	Relation	SNOMED_ID	DOID
Atherosclerotic cardiovascular disease	indication	72092001
Familial hypercholesterolemia - heterozygous	indication	238079002

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8809292	May 10, 2027	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8809292	May 10, 2027	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8809292	May 10, 2027	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8222222	Dec. 29, 2027	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8222222	Dec. 29, 2027	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8222222	Dec. 29, 2027	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10131907	Aug. 24, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10131907	Aug. 24, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10131907	Aug. 24, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8828956	Dec. 4, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8828956	Dec. 4, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8828956	Dec. 4, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	9370582	Dec. 4, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	9370582	Dec. 4, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	9370582	Dec. 4, 2028	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8106022	Dec. 12, 2029	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8106022	Dec. 12, 2029	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	8106022	Dec. 12, 2029	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10125369	Aug. 18, 2034	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10125369	Aug. 18, 2034	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10125369	Aug. 18, 2034	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10851377	Aug. 25, 2036	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF ADULTS WITH HYPERCHOLESTEROLEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10851377	Aug. 25, 2036	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) BY INHIBITING EXPRESSION OF THE PCSK9 GENE
EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)	LEQVIO	NOVARTIS	N214012	Dec. 22, 2021	RX	SOLUTION	SUBCUTANEOUS	10851377	Aug. 25, 2036	AS AN ADJUNCT TO DIET AND EXERCISE FOR THE TREATMENT OF PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Asialoglycoprotein receptor 1	Membrane receptor	P07306	ASGR1_HUMAN	BINDING AGENT			UNKNOWN	DRUG LABEL
Asialoglycoprotein receptor 2	Membrane receptor	P07307	ASGR2_HUMAN	BINDING AGENT			UNKNOWN	DRUG LABEL
Proprotein convertase subtilisin/kexin type 9	Enzyme	Q8NBP7	PCSK9_HUMAN	ANTISENSE INHIBITOR	IC50	11.54	DRUG LABEL	DRUG LABEL

ID	Source
CHEBI:176399	CHEBI
CHEMBL3990033	ChEMBL_ID
C585830	MESH_SUPPLEMENTAL_RECORD_UI
13624	IUPHAR_LIGAND_ID
DB14901	DRUGBANK_ID
1306560009	SNOMEDCT_US
39492511000001108	SNOMEDCT_US
4041078	VANDF
C4307388	UMLSCUI
D11931	KEGG_DRUG
CHEMBL5095052	ChEMBL_ID
10268	INN_ID
345011	MMSL
d09728	MMSL
018725	NDDF
UOW2C71PG5	UNII
2588243	RXNORM