vutrisiran

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Stem definition	Drug id	CAS RN
small interfering RNA including siRNA, miRNA and piRNA	5699	1867157-35-4

Stem definition

Drug id

CAS RN

small interfering RNA including siRNA, miRNA and piRNA

5699

1867157-35-4

Description:

Molecule	Description
Molfile Synonyms: vutrisiran amvuttra vutrisiran sodium ALN-65492 ALN-TTRSC02	Vutrisiran is a double-stranded siRNA-GalNAc conjugate that causes degradation of mutant and wild-type TTR mRNA through RNA interference, which results in a reduction of serum TTR protein and TTR protein deposits in tissues. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

vutrisiran
amvuttra
vutrisiran sodium
ALN-65492
ALN-TTRSC02

Vutrisiran is a double-stranded siRNA-GalNAc conjugate that causes degradation of mutant and wild-type TTR mRNA through RNA interference, which results in a reduction of serum TTR protein and TTR protein deposits in tissues.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Date	Agency	Company
June 13, 2022	FDA	ALNYLAM PHARMS INC
June 13, 2022	EMA	ALNYLAM NETHERLANDS B.V.
Sept. 26, 2022	PMDA	ALNYLAM JAPAN, K.K

Date

Agency

Company

Orphan

June 13, 2022

FDA

ALNYLAM PHARMS INC

June 13, 2022

EMA

ALNYLAM NETHERLANDS B.V.

Sept. 26, 2022

PMDA

ALNYLAM JAPAN, K.K

FDA Adverse Event Reporting System (Geriatric)

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
Intentional dose omission	91.31	49.94	18	220	20062	110568999
Death	69.40	49.94	32	206	698837	109890224

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

Intentional dose omission

91.31

49.94

220

20062

110568999

Death

69.40

49.94

206

698837

109890224

Pharmacologic Action:

Source	Code	Description
ATC	N07XX18	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs
FDA CS	M0406100	RNA, Small Interfering
FDA PE	N0000008852	Decreased RNA Integrity
FDA PE	N0000009531	Increased Protein Breakdown
FDA EPC	N0000193848	Small Interfering RNA
FDA EPC	N0000193849	Transthyretin-directed RNA Interaction

Source

Code

Description

ATC

N07XX18

NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
OTHER NERVOUS SYSTEM DRUGS
Other nervous system drugs

FDA CS

M0406100

RNA, Small Interfering

FDA PE

N0000008852

Decreased RNA Integrity

FDA PE

N0000009531

Increased Protein Breakdown

FDA EPC

N0000193848

Small Interfering RNA

FDA EPC

N0000193849

Transthyretin-directed RNA Interaction

Disease	Relation	SNOMED_ID	DOID
Transthyretin familial amyloid polyneuropathy	indication	42295001

Disease

Relation

SNOMED_ID

DOID

Transthyretin familial amyloid polyneuropathy

indication

42295001

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	10131907	Aug. 24, 2028	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	8828956	Dec. 4, 2028	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	9370581	Dec. 4, 2028	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	8106022	Dec. 12, 2029	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	10570391	Nov. 16, 2032	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	9399775	Nov. 16, 2032	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	10612024	Aug. 14, 2035	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	11401517	Aug. 14, 2035	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	10208307	July 28, 2036	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	10683501	July 28, 2036	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	11286486	July 28, 2036	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	12049628	July 28, 2036	AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

Formulation strength

Trade name

Applicant

Application number

Approval date

Type

Dose form

Route

Patent number

Patent expiration date

Patent use

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

10131907

Aug. 24, 2028

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

8828956

Dec. 4, 2028

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

9370581

Dec. 4, 2028

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

8106022

Dec. 12, 2029

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

10570391

Nov. 16, 2032

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

9399775

Nov. 16, 2032

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

10612024

Aug. 14, 2035

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

11401517

Aug. 14, 2035

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

10208307

July 28, 2036

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

10683501

July 28, 2036

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

11286486

July 28, 2036

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

12049628

July 28, 2036

AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	June 13, 2027	NEW CHEMICAL ENTITY
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	March 20, 2028	TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	June 13, 2029	INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	AMVUTTRA	ALNYLAM PHARMS INC	N215515	June 13, 2022	RX	SOLUTION	SUBCUTANEOUS	March 20, 2032	TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS

Formulation strength

Trade name

Applicant

Application number

Approval date

Type

Dose form

Route

Exclusivity date

Description

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

June 13, 2027

NEW CHEMICAL ENTITY

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

March 20, 2028

TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

June 13, 2029

INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)

AMVUTTRA

ALNYLAM PHARMS INC

N215515

June 13, 2022

SOLUTION

SUBCUTANEOUS

March 20, 2032

TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY, CARDIOVASCULAR HOSPITALIZATIONS AND URGENT HEART FAILURE VISITS

Bioactivity Summary:

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
transthyretin (TTR) mRNA	RNA	P02766	TTHY_HUMAN	ANTISENSE INHIBITOR	IC50	9.97	DRUG LABEL	DRUG LABEL

Target

Class

Pharos

UniProt

Action

Type

Activity value
(-log[M])

Mechanism
action

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

transthyretin (TTR) mRNA

RNA

P02766

TTHY_HUMAN

ANTISENSE INHIBITOR

IC50

9.97

DRUG LABEL

External reference:

ID	Source
CHEBI:757985	CHEBI
CHEMBL4594511	ChEMBL_ID
C000731927	MESH_SUPPLEMENTAL_RECORD_UI
13616	IUPHAR_LIGAND_ID
DB16699	DRUGBANK_ID
41463211000001109	SNOMEDCT_US
41463311000001101	SNOMEDCT_US
4041547	VANDF
C5446328	UMLSCUI
CHEMBL5095303	ChEMBL_ID
10579	INN_ID
D11917	KEGG_DRUG
359855	MMSL
40746	MMSL
d09899	MMSL
019095	NDDF
019096	NDDF
GB4I2JI8UI	UNII
2604578	RXNORM

Source

CHEBI:757985

CHEBI

CHEMBL4594511

ChEMBL_ID

C000731927

MESH_SUPPLEMENTAL_RECORD_UI

IUPHAR_LIGAND_ID

DRUGBANK_ID

SNOMEDCT_US

SNOMEDCT_US

4041547

VANDF

C5446328

UMLSCUI

CHEMBL5095303

ChEMBL_ID

10579

INN_ID

D11917

KEGG_DRUG

359855

MMSL

40746

MMSL

d09899

MMSL

019095

NDDF

019096

NDDF

GB4I2JI8UI

UNII

2604578

RXNORM

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
AMVUTTRA	HUMAN PRESCRIPTION DRUG LABEL	1	71336-1003	INJECTION	25 mg	SUBCUTANEOUS	NDA	29 sections
AMVUTTRA	HUMAN PRESCRIPTION DRUG LABEL	1	71336-1003	INJECTION	25 mg	SUBCUTANEOUS	NDA	29 sections

Product

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vutrisiran 🐶 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: