Glipizide

For type 2 diabetes mellitus. Sold as Glucotrol, Glucotrol Xl. Every FDA application for this active ingredient: 2 branded and 21 generic.

As of Nov 15, 2026, FDA lists 23 applications for Glipizide (sold as Glucotrol, Glucotrol Xl), first approved May 8, 1984, with 2 new uses approved and 0 published complete response letters.

First approved: May 8, 1984
Applications: 23
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $93.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Glipizide	Part D	$48.1M	+11%	1,145,603
Glipizide ER	Part D	$45.8M	-3%	863,123
Glucotrol XL	Part D	$16K	-69%	121
Glipizide XL	Part D	$1K	-100%	40

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

GLIPIZIDE 10 MG TABLET: $0.043 per unitGeneric · -8% in a year
GLIPIZIDE 2.5 MG TABLET: $1.25 per unitGeneric · 0% in a year
GLIPIZIDE 5 MG TABLET: $0.033 per unitGeneric · -6% in a year
GLIPIZIDE ER 10 MG TABLET: $0.125 per unitGeneric · -8% in a year
GLIPIZIDE ER 2.5 MG TABLET: $0.098 per unitGeneric · -10% in a year
GLIPIZIDE ER 5 MG TABLET: $0.076 per unitGeneric · -7% in a year

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney DiseaseDiabetic Kidney Disease (DKD), Type 2 Diabetes · Beijing University of Chinese Medicine	Phase 2	Active, not recruiting	Oct 30, 2026
Role of KATP Channel Loss in Type 2 DiabetesObesity and Type 2 Diabetes · Washington University School of Medicine	Not applicable	Recruiting	Feb 17, 2025
A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic CancerPancreatic Cancer, Pancreatic Carcinoma · Memorial Sloan Kettering Cancer Center	Phase 2	Active, not recruiting	Dec 13, 2023
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes StudyCardiovascular Events, Type2 Diabetes · Brigham and Women's Hospital	—	Active, not recruiting	Feb 2, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 8, 1984	GlucotrolNDA 17783 · New molecular entity	Pfizer	20	Discontinued
Apr 26, 1994	Glucotrol XlNDA 20329 · New dosage form	Pfizer	22	Marketed
May 10, 1994	GlipizideANDA 74226	Aurobindo Pharma USA	7	Marketed
Nov 22, 1994	GlipizideANDA 74370	Watson Labs	2	Discontinued
Nov 28, 1994	GlipizideANDA 74378	Oxford Pharms	4	Marketed
Feb 27, 1995	GlipizideANDA 74223	Watson Labs Teva	12	Marketed
Apr 7, 1995	GlipizideANDA 74305	Aiping Pharm Inc	16	Marketed
Jun 20, 1995	GlipizideANDA 74438	Pharmobedient	3	Discontinued
Jun 20, 1995	GlipizideANDA 74542	Chartwell Rx	1	Discontinued
Aug 31, 1995	GlipizideANDA 74497	Ani Pharms	13	Marketed
Mar 4, 1996	GlipizideANDA 74387	Ani Pharms	3	Discontinued
Apr 4, 1997	GlipizideANDA 74619	Barr Labs Inc	3	Discontinued
Sep 11, 1997	GlipizideANDA 74550	Accord Hlthcare	9	Discontinued
Jun 13, 2001	GlipizideANDA 75795	Apotex	5	Marketed
Sep 8, 2003	GlipizideANDA 76467	Watson Labs	10	Marketed
Jul 11, 2006	GlipizideANDA 77820	Sun Pharm Inds Inc	5	Discontinued
Sep 20, 2013	GlipizideANDA 76159	Ph Health	3	Discontinued
May 19, 2015	GlipizideANDA 202298	Pharmobedient	3	Discontinued
Dec 29, 2016	GlipizideANDA 204720	Unique	2	Marketed
May 12, 2017	GlipizideANDA 206928	Aurobindo Pharma	3	Marketed
Jul 16, 2018	GlipizideANDA 203499	Zydus Pharms	1	Marketed
Oct 3, 2023	GlipizideANDA 214874	Rubicon Research	1	Marketed
Mar 4, 2026	GlipizideANDA 219159	Graviti Pharms	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA