Amaryl, Avaglim(glimepiride)
Amaryl, Avaglim, Avandaryl, Duetact, Tandemact (glimepiride) is a small molecule pharmaceutical. Glimepiride was first approved as Amaryl on 1995-11-30. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus.
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Commercial
Trade Name
FDA
EMA
Amaryl (generic drugs available since 2005-10-06)
CombinationsDuetact (generic drugs available since 2005-10-06, discontinued: Avandaryl)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glimepiride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMARYL | Sanofi | N-020496 RX | 1995-11-30 | 3 products, RLD |
Glimepiride
+
Pioglitazone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUETACT | Takeda | N-021925 RX | 2006-07-28 | 2 products, RLD |
Glimepiride
+
Rosiglitazone maleate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AVANDARYL | SB Pharmco | N-021700 DISCN | 2005-11-23 | 5 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amaryl | New Drug Application | 2021-01-27 |
| duetact | New Drug Application | 2021-01-13 |
| glimepiride | ANDA | 2023-06-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
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
— A10BB12: Glimepiride
— A10BD: Combinations of oral blood glucose lowering drugs
— A10BD04: Glimepiride and rosiglitazone
— A10BD06: Glimepiride and pioglitazone
HCPCS
No data
Clinical
Clinical Trials
209 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 | 8 | 12 | 74 | 58 | 18 | 167 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | 5 | 3 | — | 9 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 1 | 2 | 3 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | 1 | — | 1 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | 1 | — | 1 |
| Heart disease risk factors | D000082742 | — | — | — | 1 | — | 1 | ||
| Coronary artery disease | D003324 | I25.1 | — | — | — | 1 | — | 1 | |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | 1 | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 14 | — | — | — | 2 | 16 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary disease | D003327 | — | — | — | — | 1 | 1 | ||
| Glucose metabolism disorders | D044882 | — | — | — | — | 1 | 1 | ||
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | — | 1 | 1 |
| Cohort studies | D015331 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | GLIMEPIRIDE |
| INN | glimepiride |
| Description | Glimepiride is a sulfonamide, a N-acylurea and a N-sulfonylurea. It has a role as a hypoglycemic agent and an insulin secretagogue. |
| Classification | Small molecule |
| Drug class | antidiabetics |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O |
Identifiers
| PDB | — |
| CAS-ID | 93479-97-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1481 |
| ChEBI ID | 5383 |
| PubChem CID | 3476 |
| DrugBank | DB00222 |
| UNII ID | 6KY687524K (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Duetact
Adverse Events
Top Adverse Reactions
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10,346 adverse events reported
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