Donidalorsen
Donidalorsen is an oligonucleotide pharmaceutical. It is currently being investigated in clinical studies.
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FDA approval date
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Study first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Dawnzera
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Donidalorsen sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DAWNZERA (AUTOINJECTOR) | Ionis Pharmaceuticals | N-219407 RX | 2025-08-21 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dawnzera | New Drug Application | 2025-09-24 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
No data
Clinical
Clinical Trials
6 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hereditary angioedemas | D054179 | EFO_0004131 | — | — | 2 | 2 | — | 1 | 5 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | — | 2 | 2 | — | 1 | 5 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Donidalorsen |
| INN | donidalorsen |
| Description | Donidalorsen is an oligonucleotide pharmaceutical. It is currently being investigated in clinical studies. |
| Classification | Oligonucleotide |
| Drug class | antisense oligonucleotides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4650235 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | ZD4D8M32TL (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 33 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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