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
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 |
|---|---|---|
| sezaby | New Drug Application | 2022-12-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| benign neonatal epilepsy | — | D020936 | — |
| febrile seizures | HP_0002373 | D003294 | R56.0 |
| hyperbilirubinemia | — | D006932 | — |
| partial epilepsies | EFO_0004263 | D004828 | — |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PHENOBARBITAL SODIUM, SEZABY, SUN PHARM INDS INC | |||
| 2029-11-17 | ODE-414 | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2560 | Injection, phenobarbital sodium, up to 120 mg |
Clinical
Clinical Trials
37 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Seizures | D012640 | G40.4 | 2 | 3 | 1 | 2 | 1 | 7 | |
| Alcohol withdrawal delirium | D000430 | EFO_1000800 | — | — | — | 1 | 2 | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | 4 | — | 3 | 7 |
| Neonatal abstinence syndrome | D009357 | EFO_0005799 | P96.1 | — | 1 | 2 | — | 1 | 4 |
| Status epilepticus | D013226 | EFO_0008526 | G41 | — | 1 | 1 | — | — | 2 |
| Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
| Depression | D003863 | F33.9 | — | — | 1 | — | — | 1 | |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Benign neonatal epilepsy | D020936 | — | — | 1 | — | — | 1 | ||
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | — | 1 | — | — | 2 | 3 | |
| Castration-resistant prostatic neoplasms | D064129 | — | 1 | — | — | — | 1 | ||
| Triple negative breast neoplasms | D064726 | 1 | 1 | — | — | — | 1 | ||
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | 1 | — | — | — | 1 |
| Brain hypoxia-ischemia | D020925 | EFO_1000846 | P91.6 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | 1 | 1 | ||
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 1 | 1 |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | — | 1 | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | — | — | — | — | 1 | 1 |
| Fecal incontinence | D005242 | R15 | — | — | — | — | 1 | 1 | |
| Alcohol withdrawal seizures | D020270 | — | — | — | — | 1 | 1 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Bile duct neoplasms | D001650 | — | — | — | — | 1 | 1 |
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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 | 8134 |
| 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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Sezaby
Adverse Events
Top Adverse Reactions
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6,457 adverse events reported
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