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Glimepiride

Generic Name
Glimepiride
Brand Names
Duetact, Tandemact
Drug Type
Small Molecule
Chemical Formula
C24H34N4O5S
CAS Number
93479-97-1
Unique Ingredient Identifier
6KY687524K

Overview

First introduced in 1995, glimepiride is a member of the second-generation sulfonylurea (SU) drug class used for the management of type 2 diabetes mellitus (T2DM) to improve glycemic control. Type 2 diabetes is a metabolic disorder with increasing prevalences worldwide; it is characterized by insulin resistance in accordance with progressive β cell failure and long-term microvascular and macrovascular complications that lead to co-morbidities and mortalities. Sulfonylureas are one of the insulin secretagogues widely used for the management of type 2 diabetes to lower blood glucose levels. The main effect of SUs is thought to be effective when residual pancreatic β-cells are present, as they work by stimulating the release of insulin from the pancreatic beta cells and they are also thought to exert extra-pancreatic effects, such as increasing the insulin-mediated peripheral glucose uptake. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (K channels) and causing depolarization of the beta cells. Compared to glipizide, another second SU drug, glimepiride has a longer duration of action. It is sometimes classified as a third-generation SU because it has larger substitutions than other second-generation SUs. Compared to other SUs, glimepiride was associated with a lower risk of developing hypoglycemia and weight gain in clinical trials as well as fewer cardiovascular effects than other SUs due to minimal effects on ischemic preconditioning of cardiac myocytes. It is effective in reducing fasting plasma glucose, postprandial glucose, and glycosylated hemoglobin levels and is considered to be a useful, cost-effective treatment option for managing type 2 diabetes mellitus. Glimepiride was approved by the Food and Drug Administration (FDA) in the United States in 1995 for the treatment of T2DM. It is commonly marketed under the brand name Amaryl as oral tablets and is typically administered once daily.

Background

First introduced in 1995, glimepiride is a member of the second-generation sulfonylurea (SU) drug class used for the management of type 2 diabetes mellitus (T2DM) to improve glycemic control. Type 2 diabetes is a metabolic disorder with increasing prevalences worldwide; it is characterized by insulin resistance in accordance with progressive β cell failure and long-term microvascular and macrovascular complications that lead to co-morbidities and mortalities. Sulfonylureas are one of the insulin secretagogues widely used for the management of type 2 diabetes to lower blood glucose levels. The main effect of SUs is thought to be effective when residual pancreatic β-cells are present, as they work by stimulating the release of insulin from the pancreatic beta cells and they are also thought to exert extra-pancreatic effects, such as increasing the insulin-mediated peripheral glucose uptake. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (K channels) and causing depolarization of the beta cells. Compared to glipizide, another second SU drug, glimepiride has a longer duration of action. It is sometimes classified as a third-generation SU because it has larger substitutions than other second-generation SUs. Compared to other SUs, glimepiride was associated with a lower risk of developing hypoglycemia and weight gain in clinical trials as well as fewer cardiovascular effects than other SUs due to minimal effects on ischemic preconditioning of cardiac myocytes. It is effective in reducing fasting plasma glucose, postprandial glucose, and glycosylated hemoglobin levels and is considered to be a useful, cost-effective treatment option for managing type 2 diabetes mellitus. Glimepiride was approved by the Food and Drug Administration (FDA) in the United States in 1995 for the treatment of T2DM. It is commonly marketed under the brand name Amaryl as oral tablets and is typically administered once daily.

Indication

Glimepiride is indicated for the management of type 2 diabetes in adults as an adjunct to diet and exercise to improve glycemic control as monotherapy. It may also be indicated for use in combination with metformin or insulin to lower blood glucose in patients with type 2 diabetes whose high blood sugar levels cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic (a drug used to lower blood sugar levels) agent alone.

Associated Conditions

  • Type 2 Diabetes Mellitus

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NuCare Pharmaceuticals, Inc.
68071-1910
ORAL
2 mg in 1 1
2/22/2021
Preferred Pharmaceuticals Inc.
68788-8066
ORAL
4 mg in 1 1
7/11/2023
Accord Healthcare Inc
16729-003
ORAL
4 mg in 1 1
11/28/2023
Rising Pharma Holdings, Inc.
16571-775
ORAL
4 mg in 1 1
10/30/2023
Golden State Medical Supply, Inc.
60429-919
ORAL
2 mg in 1 1
2/21/2024
Micro Labs Limited
42571-104
ORAL
6 mg in 1 1
12/2/2021
Legacy Pharmaceutical Packaging, LLC
68645-573
ORAL
4 mg in 1 1
12/13/2023
Proficient Rx LP
63187-698
ORAL
1 mg in 1 1
10/1/2022
Northwind Pharmaceuticals, LLC
51655-120
ORAL
4 mg in 1 1
1/20/2023
Accord Healthcare Inc
16729-002
ORAL
2 mg in 1 1
11/28/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
1/8/2007

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
AMARYL 2.0 TABLETS 2 mg
SIN10459P
TABLET
2 mg
11/20/1998
AMARYL 1.0 TABLETS 1 mg
SIN10460P
TABLET
1 mg
11/20/1998
DIALOSA TABLET 3MG
SIN13674P
TABLET
3MG
7/20/2009
AMARYL 3.0 TABLETS 3 mg
SIN10462P
TABLET
3 mg
11/20/1998
DIALOSA TABLET 2MG
SIN13675P
TABLET
2.00MG
7/20/2009
DIAPRIDE-1 TABLET 1 mg
SIN12367P
TABLET
1 mg
7/24/2003
DIAPRIDE-2 TABLET 2 mg
SIN12366P
TABLET
2 mg
7/24/2003

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Glimepiride Orally Disintegrating Tablets
国药准字H20080704
化学药品
片剂
1/5/2023
Glimepiride Pills
国药准字H20041773
化学药品
滴丸剂
2/6/2020
Glimepiride Dispersible Tablets
国药准字H20140088
化学药品
片剂
6/3/2024
Glimepiride Dispersible Tablets
国药准字H20140087
化学药品
片剂
6/3/2024
Glimepiride Dispersible Tablets
国药准字H20100183
化学药品
片剂
10/23/2020
Glimepiride Dispersible Tablets
国药准字H20100182
化学药品
片剂
10/23/2020
Glimepiride Tablets
国药准字H20031079
化学药品
片剂
8/13/2020
Glimepiride Tablets
国药准字H20205029
化学药品
片剂
5/27/2022
Glimepiride Tablets
国药准字H20010569
化学药品
片剂
1/9/2020
Glimepiride Tablets
国药准字H20010575
化学药品
片剂
8/13/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
GLIMARYL TAB 2MG
N/A
N/A
N/A
2/9/2009
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