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 | 2024-12-05 |
| donnatal extentabs | unapproved drug other | 2011-10-17 |
| phenobarbital | unapproved drug other | 2025-09-29 |
| phenobarbital oral solution | unapproved drug other | 2025-02-11 |
| phenobarbital sodium | unapproved drug other | 2025-08-18 |
| 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 | 2025-09-22 |
| 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 | — | 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
343 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 | 44 | 14 | 4 | 40 | 104 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | 1 | 1 | 24 | 27 |
| Seizures | D012640 | — | G40.4 | 4 | 5 | 5 | 3 | 6 | 20 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | 2 | 4 | 2 | 6 | 14 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 2 | 9 | 11 |
| Pathologic constriction | D003251 | — | — | — | — | — | 1 | 10 | 11 |
| Syndrome | D013577 | — | — | — | 1 | 1 | 2 | 6 | 10 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 2 | 6 | 8 |
| Coronary stenosis | D023921 | EFO_1000882 | — | — | — | — | 1 | 7 | 8 |
| Asthma | D001249 | EFO_0000270 | J45 | 4 | 5 | 2 | 1 | — | 8 |
Show 27 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 | 8 | 1 | — | 5 | 14 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 2 | — | 6 | 8 |
| Dyspnea | D004417 | — | R06.0 | 2 | 3 | 2 | — | — | 5 |
| 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 |
| Sclerosis | D012598 | — | — | — | — | 2 | — | — | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 1 | — | 1 | 2 |
| Rectal neoplasms | D012004 | — | — | — | — | 1 | — | 1 | 2 |
Show 17 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 3 | — | — | 5 | 9 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 3 | — | — | 5 | 8 |
| Glioblastoma | D005909 | EFO_0000515 | — | 5 | 2 | — | — | — | 6 |
| Gliosarcoma | D018316 | — | — | 5 | 2 | — | — | — | 6 |
| Adenoma | D000236 | — | — | — | 1 | — | — | 4 | 5 |
| Astrocytoma | D001254 | EFO_0000271 | — | 4 | 1 | — | — | — | 4 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | 3 | 4 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | 3 | 4 |
| Respiratory sounds | D012135 | — | R06.1 | 2 | 3 | — | — | — | 3 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 1 | — | — | — | 2 |
Show 20 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 |
| Glioma | D005910 | EFO_0000520 | — | 4 | — | — | — | — | 4 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 3 | 4 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | 2 | 3 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | 1 | 2 |
| Dentin dysplasia | D003805 | — | K00.5 | 1 | — | — | — | — | 1 |
| Neutropenia | D009503 | — | D70 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | — | 1 |
Show 19 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 | — | — | — | — | 19 | 19 |
| Coronary disease | D003327 | — | — | — | — | — | — | 13 | 13 |
| 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 |
| Colonic polyps | D003111 | — | K63.5 | — | — | — | — | 4 | 4 |
| Arteriosclerosis | D001161 | EFO_0009086 | I70 | — | — | — | — | 3 | 3 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | — | 3 | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 3 | 3 |
Show 131 more
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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Phenobarbital
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Ergotamine
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Atropa belladonna
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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Trends
PubMed Central
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Additional graphs summarizing 162,845 documents
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Safety
Black-box Warning
Black-box warning for: Sezaby
Adverse Events
Top Adverse Reactions
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10,200 adverse events reported
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