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Viltolarsen
Viltepso (viltolarsen) is an oligonucleotide pharmaceutical. Viltolarsen was first approved as Viltepso on 2020-08-12. It is used to treat duchenne muscular dystrophy in the USA.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Viltepso
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Viltolarsen
Tradename
Company
Number
Date
Products
VILTEPSONippon ShinyakuN-212154 RX2020-08-12
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
viltepsoNew Drug Application2021-03-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
duchenne muscular dystrophyEFO_0000429D020388—
Agency Specific
FDA
EMA
Expiration
Code
VILTOLARSEN, VILTEPSO, NIPPON SHINYAKU
2027-08-12ODE-280
2025-08-12NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Viltolarsen, Viltepso, Nippon Shinyaku
90799342031-08-31DS, DP
108706762031-08-31DS, DPU-3039
ATC Codes
M: Musculo-skeletal system drugs
— M09: Other drugs for disorders of the musculo-skeletal system in atc
— M09A: Other drugs for disorders of the musculo-skeletal system in atc
— M09AX: Other drugs for disorders of the musculo-skeletal system in atc
— M09AX12: Viltolarsen
HCPCS
Code
Description
J1427
Injection, viltolarsen, 10 mg
Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Duchenne muscular dystrophyD020388132118
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVILTOLARSEN
INNviltolarsen
Description
Viltolarsen, sold under the brand name Viltepso, is a medication used for the treatment of Duchenne muscular dystrophy (DMD). Viltolarsen is a Morpholino antisense oligonucleotide.
Classification
Oligonucleotide
Drug classantisense oligonucleotides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID2055732-84-6
RxCUI—
ChEMBL IDCHEMBL4298062
ChEBI ID—
PubChem CID—
DrugBankDB15005
UNII IDSXA7YP6EKX (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 271 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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4,750 adverse events reported
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