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Glipizide

Generic Name
Glipizide
Brand Names
Glucotrol
Drug Type
Small Molecule
Chemical Formula
C21H27N5O4S
CAS Number
29094-61-9
Unique Ingredient Identifier
X7WDT95N5C

Overview

Glipizide is an oral hypoglycemic agent in the second-generation sulfonylurea drug class that is used to control blood sugar levels in patients with type 2 diabetes mellitus. It was first introduced in 1984 and is available in various countries including Canada and the U.S. According to the 2018 Clinical Practice Guidelines by Diabetes Canada, sulfonylurea drugs are considered a second-line glucose-lowering therapy following metformin. Because sulfonylureas require functional pancreatic beta cells for their therapeutic effectiveness, sulfonylureas are more commonly used for early-stage type 2 diabetes when there is no progressed pancreatic failure. Compared to the first-generation sulfonylureas, such as tolbutamide and chlorpropamide, second-generation sulfonylureas contain a more non-polar side chain in their chemical structure, which enhances their hypoglycemic potency. Compared to other members of the sulfonylurea drug group, glipizide displays rapid absorption and onset of action with the shortest half-life and duration of action, reducing the risk for long-lasting hypoglycemia that is often observed with blood glucose-lowering agents. Glipizide was first approved by the FDA in 1994 and is available in extended-release tablets under the brand name Glucotrol®, as well as in combination with metformin under the brand name Metaglip®.

Indication

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions

  • Type 2 Diabetes Mellitus

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2023/12/13
Phase 2
Recruiting
2021/12/16
Phase 1
Recruiting
2021/10/11
N/A
Recruiting
2016/09/22
Phase 4
Completed
2015/11/18
Not Applicable
Completed
2013/09/26
Phase 4
Completed
2013/01/07
Phase 1
Active, not recruiting
2013/01/01
Phase 4
UNKNOWN
Shanghai Jiao Tong University School of Medicine
2012/10/03
Phase 3
Completed
2010/12/28
Phase 4
Completed
Cook County Health

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Direct_Rx
61919-715
ORAL
10 mg in 1 1
8/19/2019
NuCare Pharmaceuticals,Inc.
68071-4223
ORAL
5 mg in 1 1
8/23/2022
Aphena Pharma Solutions - Tennessee, LLC
71610-393
ORAL
10 mg in 1 1
7/6/2020
Aidarex Pharmaceuticals LLC
33261-433
ORAL
10 mg in 1 1
1/3/2014
Bryant Ranch Prepack
72162-2215
ORAL
10 mg in 1 1
1/5/2024
Roerig
0049-0174
ORAL
5 mg in 1 1
8/28/2023
REMEDYREPACK INC.
70518-3688
ORAL
5 mg in 1 1
3/27/2024
Golden State Medical Supply, Inc.
51407-621
ORAL
10 mg in 1 1
3/20/2023
Northwind Pharmaceuticals
51655-982
ORAL
10 mg in 1 1
1/1/2023
Rising Pharmaceuticals, Inc.
64980-281
ORAL
10 mg in 1 1
10/17/2018

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SUNGLUCON TABLET 5 mg
SIN10724P
TABLET
5 mg
1/29/1999
DIACTIN TABLET 5 MG
SIN13084P
TABLET
5 MG
4/12/2005
DIBIZIDE TABLETS 5 mg
SIN10183P
TABLET
5 mg
10/6/1998
MINIDIAB TABLET 5 mg
SIN04059P
TABLET
5 mg
3/28/1990
GLYNASE TABLET 5 mg
SIN08508P
TABLET
5 mg
1/5/1996
DIACON TABLET 5 mg
SIN12348P
TABLET
5 mg
7/18/2003
GLIPIZIDE TABLET 5 mg
SIN10237P
TABLET
5 mg
10/10/1998
BEAPIZIDE TABLETS 5mg
SIN10440P
TABLET
5 mg
11/16/1998

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Glipizide Extended Release Tablets
国药准字HJ20160140
化学药品
片剂
10/14/2024
Glipizide Extended Release Tablets
国药准字HJ20150361
化学药品
片剂
10/14/2024
Glipizide Extended Release Tablets
国药准字HJ20160139
化学药品
片剂
10/14/2024
Glipizide Extended Release Tablets
国药准字HJ20150360
化学药品
片剂
10/14/2024
Glipizide Extended Release Tablets
国药准字H20223472
化学药品
片剂
7/5/2022
Glipizide Extended Release Tablets
国药准字H20043436
化学药品
控释制剂
7/22/2020
Glipizide Extended Release Tablets
国药准字H20084634
化学药品
片剂
4/4/2023
Glipizide Extended Release Tablets
H20150360
化学药品
片剂
4/23/2020
Glipizide Extended Release Tablets
国药准字H20243032
化学药品
片剂
1/9/2024
Glipizide Extended Release Tablets
国药准字H20233470
化学药品
片剂
4/17/2023

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
MELIZIDE glipizide 5mg tablet
46946
Medicine
A
11/3/1993
GLIPIDIAB gipizide 5mg tablets blister pack
170384
Medicine
A
8/26/2010
Minidiab
15421
Medicine
A
9/23/1991
GLIPIZIDE tablets 5mg bulk (AF:1)
90307
Medicine
A
7/31/2002

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