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Drug ReportsTofersen
Tofersen
Qalsody (tofersen) is an oligonucleotide pharmaceutical. Tofersen was first approved as Qalsody on 2023-04-25.
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Trade Name
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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
QALSODYBiogenN-215887 RX2023-04-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
qalsodyNew Drug Application2024-11-13
Indications
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Clinical
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Drug
General
Drug common nameTofersen
INNtofersen
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.
Classification
Oligonucleotide
Drug classantisense oligonucleotides
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL3833346
ChEBI ID
PubChem CID
DrugBankDB14782
UNII ID2NU6F9601K (ChemIDplus, GSRS)
Target
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Variants
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Financial
Revenue by drug
$
£
Tofersen Ionis Pharmaceuticals
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Qalsody Biogen
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Qalsody Ionis Pharmaceuticals
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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