Phenobarbital
Sezaby (phenobarbital) is a small molecule pharmaceutical. Phenobarbital was first approved as Sezaby on 2022-11-17. It is used to treat benign neonatal epilepsy, febrile seizures, hyperbilirubinemia, partial epilepsies, and tonic-clonic epilepsy in the USA. It is known to target nuclear receptor subfamily 1 group I member 2.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Sezaby
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Phenobarbital sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SEZABY | Sun Pharmaceutical Industries | N-215910 RX | 2022-11-17 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| donnatal | unapproved drug other | 2023-01-10 |
| donnatal extentabs | unapproved drug other | 2011-10-17 |
| phenobarbital | unapproved drug other | 2024-10-29 |
| phenobarbital oral solution | unapproved drug other | 2024-11-19 |
| phenobarbital sodium | unapproved drug other | 2024-09-06 |
| phenobarbital with belladonna alkaloids | unapproved drug other | 2020-08-05 |
| phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide | unapproved drug other | 2023-01-10 |
| phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide | unapproved drug other | 2023-01-12 |
| phenohytro | unapproved drug other | 2024-04-08 |
| quadrapax | unapproved drug other | 2011-09-13 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hyperbilirubinemia | — | D006932 | — |
| partial epilepsies | EFO_0004263 | D004828 | — |
| febrile seizures | HP_0002373 | D003294 | R56.0 |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
| benign neonatal epilepsy | — | D020936 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PHENOBARBITAL SODIUM, SEZABY, SUN PHARM INDS INC | |||
| 2029-11-17 | ODE-414 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Phenobarbital Sodium, Sezaby, Sun Pharm Inds Inc | |||
| 11857683 | 2042-04-07 | DP | U-3779 |
HCPCS
Code | Description |
|---|---|
| J2560 | Injection, phenobarbital sodium, up to 120 mg |
Clinical
Clinical Trials
314 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 42 | 11 | 4 | 40 | 99 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | 1 | 1 | 24 | 27 |
| Seizures | D012640 | HP_0002069 | G40.4 | 4 | 5 | 5 | 3 | 6 | 20 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | 2 | 4 | 2 | 6 | 14 |
| Pathologic constriction | D003251 | — | — | — | — | — | 1 | 9 | 10 |
| Syndrome | D013577 | — | — | — | 1 | 1 | 2 | 6 | 10 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 2 | 7 | 9 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 2 | 6 | 8 |
| Coronary stenosis | D023921 | EFO_1000882 | — | — | — | — | 1 | 7 | 8 |
| Male breast neoplasms | D018567 | — | — | — | 1 | 1 | 1 | 4 | 7 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 3 | 7 | 1 | — | 5 | 13 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 2 | — | 6 | 8 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 1 | — | 4 | 6 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 1 | 4 | — | — | 5 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 2 | — | 3 | 5 |
| Brain stem neoplasms | D020295 | EFO_1001767 | — | — | 1 | 1 | — | — | 2 |
| Breast diseases | D001941 | — | N60-N65 | — | 1 | 1 | — | 1 | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 1 | — | 1 | 2 |
| Rectal neoplasms | D012004 | — | — | — | — | 1 | — | 1 | 2 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 2 | — | — | 2 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 4 | 6 |
| Adenoma | D000236 | — | — | — | 1 | — | — | 4 | 5 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | 3 | 4 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | 3 | 4 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 1 | — | — | — | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Nervous system neoplasms | D009423 | — | — | 1 | 2 | — | — | — | 2 |
| Neoadjuvant therapy | D020360 | — | — | — | 1 | — | — | 1 | 2 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 1 | — | — | 1 | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | 1 | 2 |
Show 8 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 2 | — | — | — | 3 | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | — | — | — | — | 4 |
| Glioma | D005910 | EFO_0000520 | — | 4 | — | — | — | — | 4 |
| Gliosarcoma | D018316 | — | — | 4 | — | — | — | — | 4 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | 2 | 3 |
| Astrocytoma | D001254 | EFO_0000271 | — | 3 | — | — | — | — | 3 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | 1 | 2 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | 1 | 2 |
| Ulcer | D014456 | MPATH_579 | — | 1 | — | — | — | 1 | 2 |
| Dentin dysplasia | D003805 | — | K00.5 | 1 | — | — | — | — | 1 |
Show 8 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 20 | 20 |
| Coronary disease | D003327 | — | — | — | — | — | — | 14 | 14 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | — | 10 | 10 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | — | 5 | 5 |
| Coronary restenosis | D023903 | EFO_0004224 | — | — | — | — | — | 4 | 4 |
| Arteriosclerosis | D001161 | EFO_0009086 | I70 | — | — | — | — | 3 | 3 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | — | 3 | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 3 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 3 | 3 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 3 | 3 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Phenobarbital |
| INN | phenobarbital |
| Description | Phenobarbital is a member of the class of barbiturates, the structure of which is that of barbituric acid substituted at C-5 by ethyl and phenyl groups. It has a role as an anticonvulsant, a sedative, an excitatory amino acid antagonist and a drug allergen. |
| Classification | Small molecule |
| Drug class | barbituric acid derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC1(c2ccccc2)C(=O)NC(=O)NC1=O |
Identifiers
| PDB | — |
| CAS-ID | 50-06-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL40 |
| ChEBI ID | 8069 |
| PubChem CID | 4763 |
| DrugBank | DB01174 |
| UNII ID | YQE403BP4D (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NR1I2
NR1I2
Organism
Homo sapiens
Gene name
NR1I2
Gene synonyms
PXR
NCBI Gene ID
Protein name
nuclear receptor subfamily 1 group I member 2
Protein synonyms
Orphan nuclear receptor PAR1, Orphan nuclear receptor PXR, Pregnane X receptor, Steroid and xenobiotic receptor, SXR
Uniprot ID
Mouse ortholog
Nr1i2 (18171)
nuclear receptor subfamily 1 group I member 2 (O54915)
Variants
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Financial
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Estimated US medical usage
Phenobarbital
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 142,145 documents
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Safety
Black-box Warning
Black-box warning for: Sezaby
Adverse Events
Top Adverse Reactions
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8,538 adverse events reported
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