Tofersen
Qalsody (tofersen) is an oligonucleotide pharmaceutical. Tofersen was first approved as Qalsody on 2023-04-25.
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Qalsody
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tofersen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QALSODY | BIOGEN MA | N-215887 RX | 2023-04-25 | 1 products, RLD, RS |
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Clinical
Clinical Trials
8 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 |
|---|---|---|---|---|---|---|---|---|---|
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | 1 | — | 3 | — | 3 | 7 |
Indications Phases 2
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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
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tofersen |
| INN | tofersen |
| Description | Tofersen, sold under the brand name Qalsody, is a medication used for the treatment of amyotrophic lateral sclerosis (ALS). Tofersen is an antisense oligonucleotide that targets the production of superoxide dismutase 1, an enzyme whose mutant form is commonly associated with ALS. It is administered as an intrathecal injection into the spinal cord with 3 inital "loading doses" at 14-day intervals, before moving to a "maintenance" dose administered every 28 days thereafter.
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| Classification | Oligonucleotide |
| Drug class | antisense oligonucleotides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3833346 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14782 |
| UNII ID | 2NU6F9601K (ChemIDplus, GSRS) |
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Qalsody – Biogen
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Tofersen – Ionis Pharmaceuticals
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Additional graphs summarizing 379 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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