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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Drug Products
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Abbreviated New Drug Application (ANDA)
Inotersen sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEGSEDI | Akcea Therapeutics | N-211172 DISCN | 2018-10-05 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tegsedi | New Drug Application | 2024-01-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| familial amyloid neuropathies | — | D028227 | E85.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
INOTERSEN SODIUM, TEGSEDI, AKCEA THERAPS | |||
| 2025-10-05 | ODE-212 | ||
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Clinical
Clinical Trials
11 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | 4 | 3 | 1 | 4 | 11 |
| Familial amyloid neuropathies | D028227 | — | E85.1 | — | 1 | 2 | 1 | 2 | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyloid neuropathies | D017772 | — | — | — | 1 | 3 | — | 1 | 4 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | 1 | 3 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 2 | — | — | 1 | 3 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Familial amyloidosis | D028226 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Inotersen |
| INN | inotersen |
| 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 class | antisense oligonucleotides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1492984-65-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297770 |
| ChEBI ID | — |
| PubChem CID | 121492004 |
| DrugBank | DB14713 |
| UNII ID | 0IEO0F56LV (ChemIDplus, GSRS) |
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Tegsedi – Akcea Therapeutics
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Tegsedi – Ionis Pharmaceuticals
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Additional graphs summarizing 917 documents
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Safety
Black-box Warning
Black-box warning for: Tegsedi
Adverse Events
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1,170 adverse events reported
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