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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 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 Application2020-06-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
spinal muscular atrophyEFO_0008525D009134G12.1
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
29 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_0008525G12.154611227
Indications Phases 3
No data
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_83419G12.0————22
TremorD014202R25.1————11
Motor neuron diseaseD016472EFO_0003782G12.2————11
DyskinesiasD020820G24————11
UltrasonographyD014463————11
Spinal anesthesiaD000775————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)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1258984-36-9
RxCUI1863556
ChEMBL IDCHEMBL3301572
ChEBI ID—
PubChem CID131801471
DrugBankDB13161
UNII ID5Z9SP3X666 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Spinraza - Biogen
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,187 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2 adverse events reported
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