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Drug ReportsGlimepiride
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
Trade Name
FDA
EMA
Glimepiride (discontinued: Amaryl, Glimepiride)
Combinations
Duetact, 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
Tradename
Company
Number
Date
Products
AMARYLSanofiN-020496 DISCN1995-11-30
3 products, RLD
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Glimepiride
+
Pioglitazone hydrochloride
Tradename
Company
Number
Date
Products
DUETACTTakedaN-021925 RX2006-07-28
2 products, RLD
Glimepiride
+
Rosiglitazone maleate
Tradename
Company
Number
Date
Products
AVANDARYLSB PharmcoN-021700 DISCN2005-11-23
5 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
duetactNew Drug Application2025-03-27
glimepirideANDA2025-10-03
glimepiride 3 mgANDA2024-08-20
pioglitazone and glimepirideNDA authorized generic2021-12-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Glimepiride / Pioglitazone Hydrochloride, Duetact, Takeda Pharms Usa
80711302028-06-08DP
77001282027-01-30DP
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
270 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGlimepiride
INNglimepiride
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 classantidiabetics
Image (chem structure or protein)Loading
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-ID93479-97-1
RxCUI—
ChEMBL IDCHEMBL1481
ChEBI ID5383
PubChem CID3476
DrugBankDB00222
UNII ID6KY687524K (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
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 purchases
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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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,861 documents
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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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10,601 adverse events reported
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