Amaryl, Avaglim(glimepiride)
Avaglim, Avandaryl, Duetact, Glimepiride, 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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Glimepiride (discontinued: Amaryl, Glimepiride)
CombinationsDuetact, Pioglitazone glimepiride (discontinued: Avandaryl, Rosiglitazone glimepiride)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glimepiride
Glimepiride
+
Pioglitazone hydrochloride
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 |
|---|---|---|
| duetact | New Drug Application | 2025-03-27 |
| glimepiride | ANDA | 2026-09-14 |
| glimepiride 3 mg | ANDA | 2024-08-20 |
| pioglitazone and glimepiride | NDA authorized generic | 2025-12-12 |
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
273 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 | 13 | 96 | 74 | 35 | 223 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 4 | 11 | 66 | 32 | 14 | 124 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 3 | 5 | 9 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | 1 | 4 | 2 | 7 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | — | — | 3 | 1 | 5 |
| Coronary disease | D003327 | — | — | — | — | 1 | 1 | 1 | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 1 | 1 | — | 2 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | 1 | 2 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | 1 | 1 | 2 |
| Diabetes complications | D048909 | — | — | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 1 | — | 2 | 4 |
| Dyslipidemias | D050171 | — | — | — | — | 4 | — | — | 4 |
| Glucose metabolism disorders | D044882 | — | — | — | — | 3 | — | 1 | 4 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 2 | — | 1 | 3 |
| Lipoatrophic diabetes mellitus | D003923 | EFO_0007346 | — | — | — | 3 | — | — | 3 |
| Hypercholesterolemia | D006937 | — | — | — | — | 1 | — | — | 1 |
| Peripheral nervous system diseases | D010523 | — | G64 | — | 1 | 1 | — | — | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | 2 | 3 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 16 | — | — | — | 3 | 19 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | 1 | 2 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 2 | 2 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 1 | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Cohort studies | D015331 | — | — | — | — | — | — | 1 | 1 |
| Recreational drug use | D000084783 | — | — | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | — | 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
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Variants
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Financial
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Estimated US medical usage
Glimepiride
Total medical expenditures per year (USD, in millions)
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Glimepiride
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Pioglitazone
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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Glimepiride
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Rosiglitazone
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
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Duetact, Pioglitazone and glimepiride
Adverse Events
Top Adverse Reactions
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10,774 adverse events reported
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