Dantrolene
Dantrium, Dantrolene, Revonto, 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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Commercial
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 |
|---|---|---|---|---|
| RYANODEX | Eagle Pharmaceuticals | N-205579 RX | 2014-07-22 | 1 products, RLD, RS |
| DANTRIUM | Par Pharmaceutical | N-017443 RX | 1982-01-01 | 3 products, RLD |
| DANTRIUM | Par Pharmaceutical | N-018264 RX | 1982-01-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dantrium | New Drug Application | 2024-06-24 |
| dantrolene | ANDA | 2022-02-09 |
| dantrolene sodium | ANDA | 2024-08-20 |
| revonto | ANDA | 2024-05-14 |
| ryanodex | New Drug Application | 2024-04-08 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dantrolene Sodium, Ryanodex, Eagle Pharms | |||
| 7758890 | 2025-06-30 | DP | |
HCPCS
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Clinical
Clinical Trials
11 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | 2 | 3 | 1 | — | — | 3 |
| Heat stroke | D018883 | EFO_1001340 | T67.01 | — | 1 | 1 | — | — | 2 |
| Sunstroke | D013474 | — | T67.01 | — | 1 | 1 | — | — | 2 |
| Ventricular tachycardia | D017180 | — | I47.2 | — | 1 | 1 | — | — | 1 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | 1 | 1 | — | — | 1 |
| Heat stress disorders | D018882 | — | T67.2 | — | — | 1 | — | — | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | — | 1 | 1 | — | — | 1 |
| Hyperthermia | D000084462 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 2 | 2 | — | — | — | 2 |
| Intracranial vasospasm | D020301 | EFO_1000994 | G45.9 | 2 | 2 | — | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | 1 | — | — | — | 1 |
| Ataxia | D001259 | — | R27.0 | 1 | 1 | — | — | — | 1 |
| Atrophy | D001284 | — | — | 1 | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 1 |
| Wolfram syndrome | D014929 | Orphanet_3463 | E13.8 | 1 | 1 | — | — | — | 1 |
| Optic atrophy | D009896 | HP_0000648 | H47.2 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dantrolene |
| INN | dantrolene |
| 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-ID | 7261-97-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201288 |
| ChEBI ID | — |
| PubChem CID | 2952 |
| DrugBank | DB01219 |
| UNII ID | F64QU97QCR (ChemIDplus, GSRS) |
Target
Agency Approved
RYR1
RYR1
Organism
Homo sapiens
Gene name
RYR1
Gene synonyms
RYDR
NCBI Gene ID
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
Mouse ortholog
Ryr1 (20190)
ryanodine receptor 1 (Q99JF9)
Alternate
Variants
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Financial
Revenue by drug
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Ryanodex – Eagle Pharmaceuticals
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Estimated US medical usage
Dantrolene
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 4,529 documents
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Safety
Black-box Warning
Black-box warning for: Dantrolene sodium
Adverse Events
Top Adverse Reactions
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379 adverse events reported
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