Carbamazepine
Carbatrol, Equetro, Tegretol (carbamazepine) is a small molecule pharmaceutical. Carbamazepine was first approved as Tegretol on 1982-01-01. It is used to treat bipolar disorder, complex partial epilepsy, mood disorders, post-traumatic stress disorders, and psychotic disorders amongst others in the USA. It is known to target frizzled-8.
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Novartis Pharmaceuticals
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Commercial
Trade Name
FDA
EMA
Carbatrol, Equetro, Tegretol (generic drugs available since 1986-09-17, discontinued: Carnexiv, Teril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Carbamazepine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TEGRETOL | Novartis | N-016608 RX | 1982-01-01 | 1 products, RLD, RS |
| TEGRETOL | Novartis | N-018927 RX | 1987-12-18 | 1 products, RLD, RS |
| TEGRETOL-XR | Novartis | N-020234 RX | 1996-03-25 | 3 products, RLD, RS |
| CARBATROL | Takeda | N-020712 RX | 1997-09-30 | 3 products, RLD |
| EQUETRO | Validus Pharmaceuticals | N-021710 RX | 2004-12-10 | 3 products, RLD, RS |
Show 2 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bipolar disorder | EFO_0000289 | D001714 | F30.9 |
| complex partial epilepsy | EFO_1000877 | D017029 | — |
| mood disorders | EFO_0004247 | D019964 | F30-F39 |
| post-traumatic stress disorders | EFO_0001358 | D013313 | F43.1 |
| psychotic disorders | — | D011618 | F20.81 |
| restless legs syndrome | EFO_0004270 | D012148 | G25.81 |
| schizophrenia | EFO_0000692 | D012559 | F20 |
| substance withdrawal syndrome | EFO_0005800 | D013375 | — |
| tonic-clonic epilepsy | EFO_0007262 | D004830 | — |
| trigeminal neuralgia | EFO_1001219 | D014277 | G50.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CARBAMAZEPINE, CARNEXIV, LUNDBECK PHARMS LLC | |||
| 2023-10-07 | ODE-124 | ||
Patent Expiration
HCPCS
No data
Clinical
Clinical Trials
93 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 3 | 1 | 8 | 5 | 4 | 21 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | — | 2 | 8 | 1 | 12 |
| Seizures | D012640 | G40.4 | — | — | 4 | 1 | 2 | 7 | |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | 1 | 1 | 1 | 2 | 4 |
| Cocaine-related disorders | D019970 | F14 | — | 3 | — | 1 | — | 4 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 2 | — | 1 | — | 3 |
| Neuralgia | D009437 | EFO_0009430 | — | — | — | 1 | 1 | 2 | |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | — | 2 | — | 2 | |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 2 | — | 2 |
| Metabolic clearance rate | D008657 | — | — | — | 1 | — | 1 |
Show 7 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | 1 | — | — | 2 |
| Dementia | D003704 | F03 | — | — | 1 | — | — | 1 | |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Depression | D003863 | F33.9 | — | — | 1 | — | — | 1 | |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
| Alpha 1-antitrypsin deficiency | D019896 | E88.01 | — | 1 | — | — | — | 1 | |
| Reflex epilepsy | D020195 | EFO_1001146 | — | 1 | — | — | — | 1 | |
| Infantile spasms | D013036 | EFO_1000643 | G40.82 | — | 1 | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 15 | — | — | — | — | 15 | ||
| Hepatitis b | D006509 | 1 | — | — | — | — | 1 | ||
| Hot flashes | D019584 | 1 | — | — | — | — | 1 | ||
| Covid-19 | D000086382 | U07.1 | 1 | — | — | — | — | 1 | |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | — | 1 | 1 | |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | — | 1 | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 1 | 1 |
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | — | — | — | 1 | 1 |
| Traumatic brain injuries | D000070642 | S06 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CARBAMAZEPINE |
| INN | carbamazepine |
| Description | Carbamazepine is a dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant. It has a role as an anticonvulsant, an EC 3.5.1.98 (histone deacetylase) inhibitor, a mitogen, a glutamate transporter activator, an antimanic drug, an analgesic, a non-narcotic analgesic, an environmental contaminant, a xenobiotic, a drug allergen and a sodium channel blocker. It is a dibenzoazepine and a member of ureas. |
| Classification | Small molecule |
| Drug class | tricyclic compounds |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)N1c2ccccc2C=Cc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 298-46-4 |
| RxCUI | 2002 |
| ChEMBL ID | CHEMBL108 |
| ChEBI ID | 3387 |
| PubChem CID | 2554 |
| DrugBank | DB00564 |
| UNII ID | 33CM23913M (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000012897 | SCN1A, 603-91G>A | drug response | 2021-03-24 | 2B |
Financial
Carbatrol - Shire
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Carbamazepine, Carbatrol, Carnexiv, Epitol, Equetro, Tegretol
Adverse Events
Top Adverse Reactions
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1,864 adverse events reported
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