Tofersen
Qalsody (tofersen) is an oligonucleotide pharmaceutical. Tofersen was first approved as Qalsody on 2023-04-25.
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Commercial
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Qalsody
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| qalsody | New Drug Application | 2024-11-13 |
Indications
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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 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | — | 2 | — | 3 | 6 |
| Sclerosis | D012598 | — | — | 1 | — | 1 | — | 2 | 4 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Nervous system diseases | D009422 | — | G00-G99 | — | — | — | — | 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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Qalsody – Ionis Pharmaceuticals
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Tofersen – Ionis Pharmaceuticals
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Additional graphs summarizing 530 documents
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Safety
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193 adverse events reported
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