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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Amondys
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New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Casimersen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMONDYS 45 | Sarepta Therapeutics | N-213026 RX | 2021-02-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amondys 45 | New Drug Application | 2024-07-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duchenne muscular dystrophy | EFO_0000429 | D020388 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CASIMERSEN, AMONDYS 45, SAREPTA THERAPS INC | |||
| 2028-02-25 | ODE-347 | ||
| 2026-02-25 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J1426 | Injection, casimersen, 10 mg |
Clinical
Clinical Trials
5 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 1 | 1 | 2 | — | 1 | 5 |
| Muscular dystrophies | D009136 | EFO_0000757 | G71.0 | 1 | 1 | 1 | — | — | 3 |
Indications Phases 2
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Casimersen |
| INN | casimersen |
| 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 class | antisense oligonucleotides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1422958-19-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297566 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14984 |
| UNII ID | X8UHF7SX0R (ChemIDplus, GSRS) |
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Amondys – Sarepta Therapeutics
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Safety
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649 adverse events reported
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