vutrisiran 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
small interfering RNA including siRNA, miRNA and piRNA 5699 1867157-35-4

Description:

MoleculeDescription

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

Drug dosage:

None

ADMET properties:

None

Approvals:

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

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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

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

DiseaseRelationSNOMED_IDDOID
Transthyretin familial amyloid polyneuropathy indication 42295001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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 June 13, 2029 INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
transthyretin (TTR) mRNA RNA ANTISENSE INHIBITOR IC50 9.97 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL4594511 ChEMBL_ID
DB16699 DRUGBANK_ID
019095 NDDF
019096 NDDF
4041547 VANDF
C5446328 UMLSCUI
CHEMBL5095303 ChEMBL_ID
10579 INN_ID
D11917 KEGG_DRUG
2604578 RXNORM
359855 MMSL
40746 MMSL
d09899 MMSL
GB4I2JI8UI UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
AMVUTTRA HUMAN PRESCRIPTION DRUG LABEL 1 71336-1003 INJECTION 25 mg SUBCUTANEOUS NDA 28 sections
AMVUTTRA HUMAN PRESCRIPTION DRUG LABEL 1 71336-1003 INJECTION 25 mg SUBCUTANEOUS NDA 28 sections