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Golodirsen
Vyondys (golodirsen) is an oligonucleotide pharmaceutical. Golodirsen was first approved as Vyondys 53 on 2019-12-12. It is used to treat duchenne muscular dystrophy in the USA.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Vyondys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Golodirsen
Tradename
Company
Number
Date
Products
VYONDYS 53Sarepta TherapeuticsN-211970 RX2019-12-12
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
vyondys 53New Drug Application2021-02-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
duchenne muscular dystrophyEFO_0000429D020388—
Agency Specific
FDA
EMA
Expiration
Code
GOLODIRSEN, VYONDYS 53, SAREPTA THERAPS INC
2026-12-12ODE-280
2024-12-12NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Golodirsen, Vyondys 53, Sarepta Theraps Inc
RE476912025-06-28DP
90240072025-06-28DS, DP
99948512025-06-28DS, DP
102275902025-06-28DS, DP
102668272025-06-28U-2675
104219662025-06-28DS, DP
109684502025-06-28DS, DP
109953372025-06-28DPU-2675
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
— M09AX08: Golodirsen
HCPCS
Code
Description
J1429
Injection, golodirsen, 10 mg
Clinical
Clinical Trials
5 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 dystrophyD0203881221—5
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 nameGOLODIRSEN
INNgolodirsen
Description
Golodirsen, sold under the brand name Vyondys 53, is a medication used for the treatment of Duchenne muscular dystrophy (DMD). It is an antisense oligonucleotide drug of phosphorodiamidate morpholino oligomer (PMO) chemistry.
Classification
Oligonucleotide
Drug classantisense oligonucleotides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297762
ChEBI ID—
PubChem CID—
DrugBankDB15593
UNII ID033072U4MZ (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vyondys - Sarepta Therapeutics, Inc.
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 450 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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11,768 adverse events reported
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