Spinraza(nusinersen)
Spinraza (nusinersen) is an oligonucleotide pharmaceutical. Nusinersen was first approved as Spinraza on 2016-12-23. It is used to treat spinal muscular atrophy in the USA. It has been approved in Europe to treat spinal muscular atrophy.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Spinraza
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| spinraza | New Drug Application | 2024-04-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| spinal muscular atrophy | EFO_0003823 | D009134 | G12.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NUSINERSEN SODIUM, SPINRAZA, BIOGEN IDEC | |||
| 2023-12-23 | ODE-127 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Nusinersen Sodium, Spinraza, Biogen Idec | |||
| 10436802 | 2035-09-11 | U-1941, U-1942, U-1943, U-1944, U-2093, U-2094 | |
| 9926559 | 2034-01-09 | U-1943 | |
| 8980853 | 2030-11-24 | U-1941 | |
| 9717750 | 2030-06-17 | U-1942, U-1943, U-2093, U-2094 | |
| 8361977 | 2030-05-27 | DS, DP | |
| 7838657 | 2027-07-11 | DP | |
| 8110560 | 2025-12-05 | U-1942, U-1943, U-1944 | |
| 10266822 | 2025-12-05 | U-1942, U-1943, U-1944 | |
| 7101993 | 2023-09-05 | DP | |
HCPCS
Code | Description |
|---|---|
| J2326 | Injection, nusinersen, 0.1 mg |
Clinical
No data
Drug
General
| Drug common name | Nusinersen |
| INN | nusinersen |
| Description | Nusinersen, marketed as Spinraza, is a medication used in treating spinal muscular atrophy (SMA), a rare neuromuscular disorder. In December 2016, it became the first approved drug used in treating this disorder.
|
| Classification | Oligonucleotide |
| Drug class | antisense oligonucleotides: neurologic indications |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301572 |
| ChEBI ID | — |
| PubChem CID | 131801471 |
| DrugBank | DB13161 |
| UNII ID | 5Z9SP3X666 (ChemIDplus, GSRS) |
Target
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Variants
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Spinraza – Biogen
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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