Eplontersen
Wainua (eplontersen) is an oligonucleotide pharmaceutical. Eplontersen was first approved as Wainua (autoinjector) on 2023-12-21.
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Commercial
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Trade Name
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Wainua
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eplontersen sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| WAINUA (AUTOINJECTOR) | AstraZeneca | N-217388 RX | 2023-12-21 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| wainua | New Drug Application | 2024-09-25 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EPLONTERSEN SODIUM, WAINUA (AUTOINJECTOR), ASTRAZENECA AB | |||
| 2030-12-21 | ODE-461 | ||
| 2028-12-21 | NCE | ||
ATC Codes
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Clinical
Clinical Trials
13 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyloidosis | D000686 | EFO_1001875 | E85 | 2 | 2 | 6 | — | 1 | 10 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 1 | 4 | — | 2 | 7 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | 2 | — | — | 2 |
| Amyloid neuropathies | D017772 | — | — | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | 1 | — | — | — | 2 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Eplontersen |
| INN | eplontersen |
| Description | Eplontersen, sold under the brand name Wainua, is a medication used for the treatment of transthyretin-mediated amyloidosis. It is a transthyretin-directed antisense oligonucleotide. It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca.
|
| Classification | Oligonucleotide |
| Drug class | antisense oligonucleotides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594334 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16199 |
| UNII ID | 0GRZ0F5XJ6 (ChemIDplus, GSRS) |
Target
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Eplontersen – Ionis Pharmaceuticals
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Wainua – AstraZeneca
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Additional graphs summarizing 139 documents
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Safety
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39 adverse events reported
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