Tolbutamide
Orinase (tolbutamide) is a small molecule pharmaceutical. Tolbutamide was first approved as Orinase on 1982-01-01. It is used to treat type 2 diabetes mellitus in the USA. The pharmaceutical is active against ATP-sensitive inward rectifier potassium channel 11. In addition, it is known to target ATP-sensitive inward rectifier potassium channel 8.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tolbutamide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORINASE | Pharmacia & Upjohn | N-010670 DISCN | 1982-01-01 | 2 products |
| TOLBUTAMIDE | Sandoz | N-012678 DISCN | 1982-01-01 | 1 products |
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Tolbutamide sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORINASE DIAGNOSTIC | Pharmacia & Upjohn | N-012095 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BB: Sulfonylureas for blood glucose lowering
— A10BB03: Tolbutamide
V: Various drug classes in atc
— V04: Diagnostic agents
— V04C: Other diagnostic agents in atc
— V04CA: Diagnostic agents for diabetes testing
— V04CA01: Tolbutamide
HCPCS
No data
Clinical
Clinical Trials
34 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | 3 | 4 | 8 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | 2 | 1 | 4 |
| Single nucleotide polymorphism | D020641 | — | — | — | — | — | 1 | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | 1 | — | — | — | 2 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 1 | 1 | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | 1 | 9 |
| Drug interactions | D004347 | — | — | 5 | — | — | — | — | 5 |
| Food-drug interactions | D018565 | — | — | 1 | — | — | — | — | 1 |
| Hereditary angioedemas | D054179 | EFO_0004131 | — | 1 | — | — | — | — | 1 |
| Angioedema | D000799 | EFO_0005532 | T78.3 | 1 | — | — | — | — | 1 |
| Hepatitis c | D006526 | — | B19.2 | 1 | — | — | — | — | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | — | — | — | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | — | — | — | — | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | — | — | — | — | 1 |
| Chronic pain | D059350 | HP_0012532 | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 2 | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 1 | 1 |
| Pancreatitis | D010195 | HP_0001733 | K85 | — | — | — | — | 1 | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tolbutamide |
| INN | tolbutamide |
| Description | Tolbutamide is an N-sulfonylurea that consists of 1-butylurea having a tosyl group attached at the 3-position. It has a role as a hypoglycemic agent, a potassium channel blocker, a human metabolite and an insulin secretagogue. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCNC(=O)NS(=O)(=O)c1ccc(C)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 64-77-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL782 |
| ChEBI ID | 27999 |
| PubChem CID | 5505 |
| DrugBank | DB01124 |
| UNII ID | 982XCM1FOI (ChemIDplus, GSRS) |
Target
Agency Approved
KCNJ11
KCNJ11
Organism
Homo sapiens
Gene name
KCNJ11
Gene synonyms
NCBI Gene ID
Protein name
ATP-sensitive inward rectifier potassium channel 11
Protein synonyms
beta-cell inward rectifier subunit, IKATP, Inward rectifier K(+) channel Kir6.2, inwardly rectifing potassium channel subfamily J member 11, inwardly rectifying potassium channel KIR6.2, inwardly-rectifying potassium channel subfamily J member 11, potassium channel inwardly rectifing subfamily J member 11, Potassium channel, inwardly rectifying subfamily J member 11, potassium voltage-gated channel subfamily J member 11
Uniprot ID
Mouse ortholog
Kcnj11 (16514)
ATP-sensitive inward rectifier potassium channel 11 (Q9QX21)
Alternate
KCNJ8
KCNJ8
Organism
Homo sapiens
Gene name
KCNJ8
Gene synonyms
NCBI Gene ID
Protein name
ATP-sensitive inward rectifier potassium channel 8
Protein synonyms
Inward rectifier K(+) channel Kir6.1, inwardly rectifying potassium channel KIR6.1, Potassium channel, inwardly rectifying subfamily J member 8, potassium voltage-gated channel subfamily J member 8, uKATP-1
Uniprot ID
Mouse ortholog
Kcnj8 (16523)
ATP-sensitive inward rectifier potassium channel 8 (P97794)
Variants
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Financial
Revenue by drug
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Estimated US medical usage
Tolbutamide
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Refill frequency
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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64 adverse events reported
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