Primidone
Mysoline (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
Trade Name
FDA
EMA
Mysoline (generic drugs available since 1982-01-01)
Drug Products
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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 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| epilepsy | EFO_0000474 | D004827 | G40.9 |
| partial epilepsies | EFO_0004263 | D004828 | — |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
| tremor | HP_0002080 | D014202 | R25.1 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
1212 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | 10 | 33 | 20 | 1 | 8 | 69 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 5 | 15 | 11 | 9 | 2 | 39 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | 13 | 9 | 11 | 1 | 36 |
| Prostatic neoplasms | D011471 | C61 | 4 | 14 | 11 | 2 | 5 | 32 | |
| Asthma | D001249 | EFO_0000270 | J45 | 2 | 4 | 7 | 9 | 6 | 28 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | 1 | 7 | 16 | 2 | 26 |
| Covid-19 | D000086382 | U07.1 | — | 7 | 13 | 3 | 5 | 25 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 4 | 6 | 6 | 5 | 3 | 23 |
| Inflammation | D007249 | 2 | 2 | 6 | 8 | 3 | 20 | ||
| Kidney transplantation | D016030 | 1 | 5 | 6 | 6 | 1 | 18 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | C95 | 9 | 41 | 13 | — | 8 | 64 | |
| Myelodysplastic syndromes | D009190 | D46 | 7 | 30 | 2 | — | 4 | 39 | |
| Graft vs host disease | D006086 | D89.81 | 5 | 19 | 9 | — | 5 | 35 | |
| Plasma cell neoplasms | D054219 | 3 | 9 | 2 | — | 4 | 18 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | 2 | 13 | 1 | — | — | 14 | |
| Neoplasms | D009369 | C80 | 3 | 5 | 3 | — | 2 | 13 | |
| Multiple myeloma | D009101 | C90.0 | 3 | 6 | 2 | — | — | 11 | |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 6 | 3 | — | 2 | 10 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | 3 | 6 | — | 2 | 9 | |
| Alcoholic hepatitis | D006519 | EFO_1001345 | K70.1 | 1 | 4 | 3 | — | 2 | 9 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | D47.1 | 3 | 7 | — | — | 2 | 12 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 2 | 11 | — | — | — | 11 | |
| Myelodysplastic-myeloproliferative diseases | D054437 | 1 | 8 | — | — | 2 | 11 | ||
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 3 | 6 | — | — | 1 | 8 |
| Neuroblastoma | D009447 | EFO_0000621 | 1 | 5 | — | — | — | 6 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 6 | — | — | — | 6 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | 4 | — | — | — | 4 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 4 | — | — | — | 4 |
| Myeloid leukemia chronic-phase | D015466 | — | 3 | — | — | — | 3 | ||
| Myelomonocytic leukemia juvenile | D054429 | C93.3 | 1 | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | 3 | — | — | — | — | 3 | ||
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | — | — | 1 | 2 | |
| Myositis | D009220 | EFO_0000783 | G72.49 | 1 | — | — | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
| T-cell lymphoma | D016399 | 1 | — | — | — | — | 1 | ||
| T-cell leukemia | D015458 | 1 | — | — | — | — | 1 | ||
| Syndrome | D013577 | 1 | — | — | — | — | 1 | ||
| Lymphoid leukemia | D007945 | C91 | 1 | — | — | — | — | 1 | |
| Innate immunity | D007113 | 1 | — | — | — | — | 1 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | — | — | 2 | 2 | |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 2 | 2 | |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 2 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | 2 | 2 | |
| Pathologic dilatation | D004108 | — | — | — | — | 2 | 2 | ||
| Regeneration | D012038 | — | — | — | — | 2 | 2 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 1 | 1 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | — | — | — | 1 | 1 |
| Hypertrophic cicatrix | D017439 | L91.0 | — | — | — | — | 1 | 1 |
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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 | 8691 |
| ChEMBL ID | CHEMBL856 |
| ChEBI ID | 8412 |
| PubChem CID | 4909 |
| DrugBank | DB00794 |
| UNII ID | 13AFD7670Q (ChemIDplus, GSRS) |
Target
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Alternate
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Trends
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Safety
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Adverse Events
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108,352 adverse events reported
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