PRIMIDONE
Mysoline, Primidone (primidone) is a small molecule pharmaceutical. Primidone was first approved as Mysoline on 1982-01-01. It is used to treat epilepsy, partial epilepsies, tonic-clonic epilepsy, and tremor in the USA. It is known to target transient receptor potential cation channel subfamily M member 3.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Mysoline, Primidone (discontinued: Mysoline, Primidone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Primidone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MYSOLINE | Bausch Health Companies | N-009170 RX | 1982-01-01 | 2 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epilepsy | EFO_0000474 | D004827 | G40.9 |
| tremor | HP_0001337 | D014202 | R25.1 |
| partial epilepsies | EFO_0004263 | D004828 | — |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Nervous system neoplasms | D009423 | — | — | 1 | 2 | — | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Gliosarcoma | D018316 | — | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
| Oligodendroglioma | D009837 | EFO_0000631 | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | — | — | 2 | 2 |
| Financial stress | D000086522 | — | — | — | — | — | — | 1 | 1 |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | — | — | — | 1 | 1 |
| Tremor | D014202 | HP_0001337 | R25.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PRIMIDONE |
| INN | primidone |
| Description | Primidone is a pyrimidone that is dihydropyrimidine-4,6(1H,5H)-dione substituted by an ethyl and a phenyl group at position 5. It is used as an anticonvulsant for treatment of various types of seizures. It has a role as an environmental contaminant, a xenobiotic and an anticonvulsant. |
| Classification | Small molecule |
| Drug class | Anticonvulsant, barbiturate |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC1(c2ccccc2)C(=O)NCNC1=O |
Identifiers
| PDB | — |
| CAS-ID | 125-33-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL856 |
| ChEBI ID | 8412 |
| PubChem CID | 4909 |
| DrugBank | DB00794 |
| UNII ID | 13AFD7670Q (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
Variants
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Financial
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Estimated US medical usage
Primidone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,566 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,121 adverse events reported
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