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Drug ReportsNusinersen
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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
Trade Name
FDA
EMA
Spinraza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nusinersen sodium
Tradename
Company
Number
Date
Products
SPINRAZABiogenN-209531 RX2016-12-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
spinrazaNew Drug Application2024-04-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
spinal muscular atrophyEFO_0003823D009134G12.1
Agency Specific
FDA
EMA
Expiration
Code
NUSINERSEN SODIUM, SPINRAZA, BIOGEN IDEC
2023-12-23ODE-127
Patent Expiration
Patent
Expires
Flag
FDA Information
Nusinersen Sodium, Spinraza, Biogen Idec
104368022035-09-11U-1941, U-1942, U-1943, U-1944, U-2093, U-2094
99265592034-01-09U-1943
89808532030-11-24U-1941
97177502030-06-17U-1942, U-1943, U-2093, U-2094
83619772030-05-27DS, DP
78386572027-07-11DP
81105602025-12-05U-1942, U-1943, U-1944
102668222025-12-05U-1942, U-1943, U-1944
71019932023-09-05DP
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
— M09AX07: Nusinersen
HCPCS
Code
Description
J2326
Injection, nusinersen, 0.1 mg
Clinical
Clinical Trials
56 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal muscular atrophyD009134EFO_0003823G12.154611227
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Muscular atrophyD009133——436—921
AtrophyD001284——436—618
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal muscular atrophies of childhoodD014897Orphanet_83419G12.1————11
ScoliosisD012600EFO_0004273M41————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNusinersen
INNnusinersen
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 classantisense oligonucleotides: neurologic indications
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3301572
ChEBI ID—
PubChem CID131801471
DrugBankDB13161
UNII ID5Z9SP3X666 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Spinraza – Biogen
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,341 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,095 adverse events reported
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