inotersen Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antisense oligonucleotides 5319 1492984-65-2

Description:

MoleculeDescription

Synonyms:

  • inotersen
  • inotersen sodium
  • tegsedi
  • ISIS 420915
Inotersen is an antisense oligonucleotide that causes degradation of mutant and wild-type TTR mRNA through binding to the TTR mRNA, 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
Oct. 5, 2018 FDA AKCEA THERAPS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC N07XX15 NERVOUS SYSTEM
OTHER NERVOUS SYSTEM DRUGS
OTHER NERVOUS SYSTEM DRUGS
Other nervous system drugs
FDA CS M0025055 Oligonucleotides, Antisense
FDA PE N0000008852 Decreased RNULL Integrity
FDA PE N0000009531 Increased Protein Breakdown
MeSH PA D015335 Molecular Probes
MeSH PA D020319 Oligodeoxyribonucleotides, Antisense
MeSH PA D016376 Oligonucleotides, Antisense
FDA EPC N0000191626 Antisense Oligonucleotide
FDA EPC N0000193849 Transthyretin-directed RNULL Interaction

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Polyneuropathy in amyloidosis indication 193187004
Glomerulonephritis contraindication 36171008 DOID:2921
Thrombocytopenic disorder contraindication 302215000 DOID:1588

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) TEGSEDI AKCEA THERAPS N211172 Oct. 5, 2018 RX SOLUTION SUBCUTANEOUS Oct. 5, 2023 NEW CHEMICAL ENTITY
EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML) TEGSEDI AKCEA THERAPS N211172 Oct. 5, 2018 RX SOLUTION SUBCUTANEOUS Oct. 5, 2025 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 UNKNOWN DRUG LABEL

External reference:

IDSource
1432726-13-0 SECONDARY_CAS_RN
4037952 VANDF
C4731850 UMLSCUI
CHEMBL4297770 ChEMBL_ID
CHEMBL4297537 ChEMBL_ID
DB14713 DRUGBANK_ID
D10940 KEGG_DRUG
C000629536 MESH_SUPPLEMENTAL_RECORD_UI
10294 INN_ID
0IEO0F56LV UNII
121493436 PUBCHEM_CID
2099289 RXNORM
294316 MMSL
35311 MMSL
d09009 MMSL
017681 NDDF
017682 NDDF
782581008 SNOMEDCT_US
782583006 SNOMEDCT_US
782797001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tegsedi HUMAN PRESCRIPTION DRUG LABEL 1 72126-007 INJECTION, SOLUTION 284 mg SUBCUTANEOUS NDA 28 sections