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Drug ReportsEteplirsen
Eteplirsen
Exondys (eteplirsen) is an oligonucleotide pharmaceutical. Eteplirsen was first approved as Exondys 51 on 2016-09-19. It is used to treat duchenne muscular dystrophy in the USA.
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Study first post date
Last update 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
Exondys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eteplirsen
Tradename
Company
Number
Date
Products
EXONDYS 51Sarepta TherapeuticsN-206488 RX2016-09-19
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
exondys 51New Drug Application2025-08-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
duchenne muscular dystrophyEFO_0000429D020388—
Agency Specific
FDA
EMA
Expiration
Code
ETEPLIRSEN, EXONDYS 51, SAREPTA THERAPS INC
2023-09-19ODE-122
Patent Expiration
Patent
Expires
Flag
FDA Information
Eteplirsen, Exondys 51, Sarepta Theraps Inc
95060582034-03-14U-1918, U-1919
103370032034-03-14U-1918
103644312034-03-14U-1918, U-1919
RE477692029-02-02DP
RE484682028-10-27U-2097
92432452028-10-27DPU-2097, U-2098
RE477512025-06-28U-1918, U-2664, U-2673, U-2674
90183682025-06-28DS, DP
107814512025-06-28DS, DP
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
— M09AX06: Eteplirsen
HCPCS
Code
Description
J1428
Injection, eteplirsen, 10 mg
Clinical
Clinical Trials
12 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
Duchenne muscular dystrophyD020388EFO_0000429—292—112
Muscular dystrophiesD009136EFO_0000757G71.0292——11
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 nameEteplirsen
INNeteplirsen
Description
Eteplirsen (oligonucleotide)
Classification
Oligonucleotide
Drug classantisense oligonucleotides
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108278
ChEBI ID—
PubChem CID—
DrugBankDB06014
UNII IDAIW6036FAS (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Exondys – Sarepta Therapeutics
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,727 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,870 adverse events reported
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