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Dantrolene
Dantrium, Ryanodex (dantrolene) is a small molecule pharmaceutical. Dantrolene was first approved as Dantrium on 1982-01-01. It is used to treat cerebral infarction, cerebral palsy, malignant hyperthermia, multiple sclerosis, and muscle spasticity amongst others in the USA. The pharmaceutical is active against ryanodine receptor 1. In addition, it is known to target ryanodine receptor 3.
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Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
cardiovascular diseasesD002318
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
wounds and injuriesD014947
Trade Name
FDA
EMA
Dantrium, Ryanodex (generic drugs available since 2005-03-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dantrolene sodium
Tradename
Company
Number
Date
Products
RYANODEXEagle PharmaceuticalsN-205579 RX2014-07-22
1 products, RLD, RS
DANTRIUMPar PharmaceuticalN-017443 RX1982-01-01
3 products, RLD
DANTRIUMPar PharmaceuticalN-018264 RX1982-01-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dantriumNew Drug Application2018-03-01
dantrolene sodiumANDA2023-06-14
revontoANDA2021-11-02
ryanodex New Drug Application2020-09-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cerebral infarction—D002544I63
cerebral palsy—D002547G80
malignant hyperthermiaOrphanet_423D008305T88.3
multiple sclerosisEFO_0003885D009103G35
muscle spasticityHP_0001257D009128—
neuroleptic malignant syndromeEFO_1001379D009459G21.0
spinal cord injuriesEFO_1001919D013119—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dantrolene Sodium, Ryanodex, Eagle Pharms
77588902025-06-30DP
86854602023-02-15U-1546
ATC Codes
M: Musculo-skeletal system drugs
— M03: Muscle relaxants
— M03C: Muscle relaxants, directly acting agents
— M03CA: Dantrolene and derivatives, muscle relaxants, direct acting
— M03CA01: Dantrolene
HCPCS
No data
Clinical
Clinical Trials
2 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
No data
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 nameDANTROLENE
INNdantrolene
Description
Dantrolene is the hydrazone resulting from the formal condensation of 5-(4-nitrophenyl)furfural with 1-aminohydantoin. A ryanodine receptor antagonist used for the relief of chronic severe spasticity and malignant hyperthermia. It has a role as a muscle relaxant, a ryanodine receptor antagonist and a neuroprotective agent. It is an imidazolidine-2,4-dione and a hydrazone. It is a conjugate acid of a dantrolene(1-).
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C1CN(/N=C/c2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1
Identifiers
PDB—
CAS-ID7261-97-4
RxCUI3105
ChEMBL IDCHEMBL1201288
ChEBI ID—
PubChem CID2952
DrugBankDB01219
UNII IDF64QU97QCR (ChemIDplus, GSRS)
Target
Agency Approved
RYR1
RYR1
Organism
Homo sapiens
Gene name
RYR1
Gene synonyms
RYDR
NCBI Gene ID
6261
Protein name
ryanodine receptor 1
Protein synonyms
central core disease of muscle, protein phosphatase 1, regulatory subunit 137, ryanodine receptor 1 (skeletal), sarcoplasmic reticulum calcium release channel, Skeletal muscle calcium release channel, Skeletal muscle ryanodine receptor, Skeletal muscle-type ryanodine receptor, Type 1 ryanodine receptor, type 1-like ryanodine receptor
Uniprot ID
Q9P1U4
Mouse ortholog
Ryr1 (20190)
ryanodine receptor 1 (Q99JF9)
Alternate
RYR3
RYR3
Organism
Homo sapiens
Gene name
RYR3
Gene synonyms
HBRR
NCBI Gene ID
6263
Protein name
ryanodine receptor 3
Protein synonyms
Brain ryanodine receptor-calcium release channel, Brain-type ryanodine receptor, Type 3 ryanodine receptor
Uniprot ID
Q15413
Mouse ortholog
Ryr3 (20192)
ryanodine receptor 3 (Q9QY91)
Variants
Clinical Variant
No data
Financial
Ryanodex - Eagle Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,028 documents
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Safety
Black-box Warning
Black-box warning for: Dantrium, Dantrolene sodium
Adverse Events
Top Adverse Reactions
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643 adverse events reported
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