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Phenobarbital sodium
Sezaby (phenobarbital sodium) is a small molecule pharmaceutical. Phenobarbital sodium 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
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
signs and symptoms pathological conditionsD013568
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
SEZABYSun Pharmaceutical IndustriesN-215910 RX2022-11-17
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
phenobarbital sodiumunapproved drug other2023-06-05
sezabyNew Drug Application2023-01-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
benign neonatal epilepsy—D020936—
febrile seizuresHP_0002373D003294R56.0
hyperbilirubinemia—D006932—
partial epilepsiesEFO_0004263D004828—
tonic-clonic epilepsyEFO_0007262D004830—
Agency Specific
FDA
EMA
Expiration
Code
PHENOBARBITAL SODIUM, SEZABY, SUN PHARM INDS INC
2029-11-17ODE-414
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AA: Barbiturates and derivatives
— N03AA02: Phenobarbital
HCPCS
Code
Description
J2560
Injection, phenobarbital sodium, up to 120 mg
Clinical
Clinical Trials
29 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SeizuresD012640G40.4231217
Alcohol withdrawal deliriumD000430EFO_1000800———123
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9——4—37
Neonatal abstinence syndromeD009357EFO_0005799P96.1—12—14
Status epilepticusD013226EFO_0008526G41—11——2
DementiaD003704F03——1——1
Psychophysiologic disordersD011602F45.9——1——1
SchizophreniaD012559EFO_0000692F20——1——1
DepressionD003863F33.9——1——1
Anxiety disordersD001008EFO_0006788F41.1——1——1
Benign neonatal epilepsyD020936——1——1
Intracranial hemorrhagesD020300EFO_0000551I62——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain diseasesD001927HP_0001298G93.40—1———1
Brain hypoxia-ischemiaD020925EFO_1000846P91.6—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeutropeniaD009503D701————1
NeoplasmsD009369C801————1
LymphomaD008223C85.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N19————11
Acute kidney injuryD058186HP_0001919N17————11
PharmacokineticsD010599————11
Alcohol withdrawal seizuresD020270————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePHENOBARBITAL SODIUM
INNphenobarbital sodium
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 classbarbituric acid derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCC1(c2ccccc2)C(=O)N=C([O-])NC1=O.[Na+]
Identifiers
PDB—
CAS-ID50-06-6
RxCUI8134
ChEMBL IDCHEMBL149972
ChEBI ID8070
PubChem CID4763
DrugBankDB01174
UNII IDSW9M9BB5K3 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
NR1I2
NR1I2
Organism
Homo sapiens
Gene name
NR1I2
Gene synonyms
PXR
NCBI Gene ID
8856
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
Q9UNW4
Mouse ortholog
Nr1i2 (18171)
nuclear receptor subfamily 1 group I member 2 (O54915)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 698 documents
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Safety
Black-box Warning
Black-box warning for: Sezaby
Adverse Events
Top Adverse Reactions
0 adverse events reported
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