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Drug ReportsViltolarsen
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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 Application2023-08-01
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 dystrophyD020388EFO_0000429—132118
Muscular dystrophiesD009136HP_0003560G71.0132118
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)Loading
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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 410 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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62 adverse events reported
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