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Tofersen
Qalsody (tofersen) is an oligonucleotide pharmaceutical. Tofersen was first approved as Qalsody on 2023-04-25.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Qalsody
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tofersen
Tradename
Company
Number
Date
Products
QALSODYBIOGEN MAN-215887 RX2023-04-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
qalsodyNew Drug Application2023-04-25
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
5 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Amyotrophic lateral sclerosisD000690EFO_0000253G12.21——3—14
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 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)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID2088232-70-4
RxCUI—
ChEMBL IDCHEMBL3833346
ChEBI ID—
PubChem CID—
DrugBankDB14782
UNII ID2NU6F9601K (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tofersen - Ionis Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 217 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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