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Drug ReportsInotersen
Tegsedi(inotersen)
Tegsedi (inotersen) is an oligonucleotide pharmaceutical. Inotersen was first approved as Tegsedi on 2018-07-06. It is used to treat familial amyloid neuropathies in the USA. It has been approved in Europe to treat amyloidosis.
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Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Inotersen sodium
Tradename
Company
Number
Date
Products
TEGSEDIAkcea TherapeuticsN-211172 DISCN2018-10-05
1 products, RLD
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FDA
EMA
Brand Name
Status
Last Update
tegsediNew Drug Application2024-01-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
familial amyloid neuropathies—D028227E85.1
Agency Specific
FDA
EMA
Expiration
Code
INOTERSEN SODIUM, TEGSEDI, AKCEA THERAPS
2025-10-05ODE-212
Patent Expiration
Patent
Expires
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FDA Information
Inotersen Sodium, Tegsedi, Akcea Theraps
86978602031-04-29DP
90610442031-04-29DP
93997742031-04-29U-2430
81017432025-04-01DS, DP
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX15: Inotersen
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameInotersen
INNinotersen
Description
Inotersen, sold under the brand name Tegsedi, is a 2'-O-(2-methoxyethyl) (2'-MOE) antisense oligonucleotide medication used for the treatment of nerve damage in adults with hereditary transthyretin-mediated amyloidosis. The sequence is TCTTG GTTACATGAA ATCCC, where C is methylated C, and the first and third section (bases 1-5 and 16–20, separated from the middle section by spaces) are MOE-modified.
Classification
Oligonucleotide
Drug classantisense oligonucleotides
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1492984-65-2
RxCUI—
ChEMBL IDCHEMBL4297770
ChEBI ID—
PubChem CID121492004
DrugBankDB14713
UNII ID0IEO0F56LV (ChemIDplus, GSRS)
Target
No data
Variants
No data
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Tegsedi – Akcea Therapeutics
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Tegsedi – Ionis Pharmaceuticals
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Estimated US medical usage
No data
Trends
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Safety
Black-box Warning
Black-box warning for: Tegsedi
Adverse Events
0 adverse events reported
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