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Casimersen
Amondys (casimersen) is an oligonucleotide pharmaceutical. Casimersen was first approved as Amondys 45 on 2021-02-25. It is used to treat duchenne muscular dystrophy in the USA.
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FDA Novel Drug Approvals 2021
Searched
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Amondys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Casimersen
Tradename
Company
Number
Date
Products
AMONDYS 45Sarepta TherapeuticsN-213026 RX2021-02-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
amondys 45New Drug Application2021-02-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
duchenne muscular dystrophyEFO_0000429D020388—
Agency Specific
FDA
EMA
Expiration
Code
CASIMERSEN, AMONDYS 45, SAREPTA THERAPS INC
2028-02-25ODE-347
2026-02-25NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Casimersen, Amondys 45, Sarepta Theraps Inc
92281872030-11-12DS, DP
97587832030-11-12U-3088, U-3089
102875862030-11-12DS, DP
107814502030-11-12U-3089
RE489602025-06-28DS, DPU-3087, U-3088
94474152025-06-28DS, 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
— M09AX13: Casimersen
HCPCS
Code
Description
J1426
Injection, casimersen, 10 mg
Clinical
Clinical Trials
4 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 dystrophyD020388112——4
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 nameCASIMERSEN
INNcasimersen
Description
Casimersen, sold under the brand name Amondys 45, is an antisense oligonucleotide medication used for the treatment of Duchenne muscular dystrophy (DMD) in people who have a confirmed mutation of the dystrophin gene that is amenable to exon 45 skipping. It is an antisense oligonucleotide of phosphorodiamidate morpholino oligomer (PMO). Duchenne muscular dystrophy is a rare disease that primarily affects boys. It is caused by low levels of a muscle protein called dystrophin. The lack of dystrophin causes progressive muscle weakness and premature death.
Classification
Oligonucleotide
Drug classantisense oligonucleotides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1422958-19-7
RxCUI—
ChEMBL IDCHEMBL4297566
ChEBI ID—
PubChem CID—
DrugBankDB14984
UNII IDX8UHF7SX0R (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Amondys - 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 220 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,592 adverse events reported
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