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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Tegsedi
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 RX2018-10-05
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tegsediNew Drug Application2020-09-02
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
2023-10-05NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Inotersen Sodium, Tegsedi, Akcea Theraps
86978602031-04-29DP
90610442031-04-29DP
93997742031-04-29U-2430
81017432025-04-01DS, DP
71019932023-09-05DP
70153152023-03-21DP
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
Clinical Trials
7 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AmyloidosisD000686EFO_1001875E85—32——4
Familial amyloid neuropathiesD028227E85.1—12——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.1————11
Familial amyloidosisD028226————11
Epidemiology
Epidemiological information for investigational and approved indications
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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
Image (chem structure or protein)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tegsedi - Akcea Therapeutics
$
€
£
₣
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Tegsedi - Ionis Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 661 documents
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Safety
Black-box Warning
Black-box warning for: Tegsedi
Adverse Events
Top Adverse Reactions
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187,701 adverse events reported
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