Glucotrol

(Glipizide)

ApprovedSmall molecule

Glipizide is used to help control blood sugar levels in people with type 2 diabetes by stimulating the pancreas to release more insulin.[2] Glucotrol is currently approved and in use across 5 indications[4].[1]

Glucotrol is one of 197 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

196

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Diabetes MellitusActive, not recruiting

Pancreatic CancerActive, not recruiting

Type 2 DiabetesActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

Pancreatic CancerPhase 2

Active, not recruiting

Type 2 DiabetesApproved

Active, not recruiting

Chronic Kidney DiseasePreclinical

Active, not recruiting

Competition

Competitive Landscape

307 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Glucotrol

Pfizer

Approved

1 2

Medrol

Pfizer

Preclinical

1 3

Byetta

AstraZeneca

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 5

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 6

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Active Comparator

Moderna

Preclinical

1 9

Secretin-Ferring

Ferring

Preclinical

1 10

Sulfonylureas

Eli Lilly

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Pancreatic Cancer

NCT06168812

Clinical

Trials by Indication[1]

Type 2 Diabetes Mellitus6 trials

An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00095056·91 enrolled

Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01020123·530 enrolled

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00509262·426 enrolled

Show 3 more trials

Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 3·NCT00856284·2,639 enrolled

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00509236·129 enrolled

A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01698775·213 enrolled

Type 2 Diabetes3 trials

Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00660907·1,217 enrolled

Efficacy of Acarbose on Intestinal Microbiome and Incretins of Type 2 Diabetes

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01758471·160 enrolled

Comparison of Type 2 Diabetes Pharmacotherapy Regimens

Completed·KKaiser Permanente··NCT05073692·241,981 enrolled

Metformin2 trials

Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT01762046·1,033 enrolled

Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00885352·313 enrolled

Type 2 Diabetic Patients2 trials

Insulin Glargine in Type 2 Diabetic Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00347100·387 enrolled

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT02911792·72 enrolled

Coronary Artery Disease1 trial

Study on the Prognosis and Effect of Anti-diabetic Drugs on Type-2 Diabetes Mellitus With Coronary Artery Disease

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT00513630·304 enrolled

9 more indications

Diabetes1 trial

Combination of Sulfonylureas and Insulin Glargine Outpatient Therapy for Unstable Diabetes and Impending DKA

Completed·CCook County Health·Phase 4·NCT00732524·80 enrolled

Atherosclerosis1 trial

Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes

Completed· GSK logo

GSK·Phase 3·NCT00116831·672 enrolled

Combination Therapy1 trial

Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00350779·262 enrolled

Tics1 trial

Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects

Completed·CChinese Academy of Sciences·N/A·NCT01082796·14 enrolled

Lip1 trial

To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets

Completed· Novartis logo

Novartis·Phase 1·NCT00946504·28 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics

Completed· Takeda logo

Takeda·Phase 3·NCT00707993·441 enrolled

Chronic Kidney Disease1 trial

Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management

Completed·UUniversity of Washington·N/A·NCT02608177·3 enrolled

Inflammation1 trial

Effect of Exenatide on Liver and Heart Fat and Inflammation

Completed·—·Phase 4·NCT01951651·24 enrolled

Pancreatic Cancer1 trial

Sulfonylurea Safety and Effectiveness (SUSS) for Patients With Hyperglycemia and Pancreatic Ductal Adenocarcinoma: A Pragmatic Clinical Trial and Accompanying Retrospective Revie

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06168812·29 enrolled

Regulatory

FDA Approval Timeline[5]

May 11, 1993

GLUCOTROL

NDA NDA017783

Apr 26, 1994

GLUCOTROL XL

NDA NDA020329

Aug 10, 1999

GLUCOTROL XL

NDA NDA020329

Aug 10, 1999

GLUCOTROL XL

NDA NDA020329

Nov 18, 1999

GLUCOTROL XL

NDA NDA020329

Dec 15, 1999

GLUCOTROL XL

NDA NDA020329

Apr 17, 2000

GLUCOTROL XL

NDA NDA020329

Jul 26, 2000

GLUCOTROL XL

NDA NDA020329

Oct 26, 2000

GLUCOTROL XL

NDA NDA020329

Oct 31, 2000

GLUCOTROL XL

NDA NDA020329

Jan 16, 2001

GLUCOTROL XL

NDA NDA020329

Jun 25, 2001

GLUCOTROL XL

NDA NDA020329

Sep 5, 2001

GLUCOTROL XL

NDA NDA020329

Oct 26, 2001

GLUCOTROL XL

NDA NDA020329

Apr 1, 2002

GLUCOTROL XL

NDA NDA020329

Sep 17, 2003

GLUCOTROL XL

NDA NDA020329

Oct 27, 2008

GLUCOTROL XL

NDA NDA020329

Aug 31, 2009

GLUCOTROL XL

NDA NDA020329

Feb 7, 2011

GLUCOTROL XL

NDA NDA020329

Oct 15, 2013

GLUCOTROL XL

NDA NDA020329

Oct 5, 2015

GLUCOTROL XL

NDA NDA020329

Aug 16, 2017

GLUCOTROL XL

NDA NDA020329

Aug 10, 2018

GLUCOTROL XL

NDA NDA020329

Aug 3, 2021

GLUCOTROL XL

NDA NDA020329

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Glipizide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Glucotrol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Glipizide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Glipizide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020329). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sulfonylurea Receptor 1, Kir6.2 Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Glucotrol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Type 2 Diabetes Mellitus6 trials

Type 2 Diabetes3 trials

Metformin2 trials

Type 2 Diabetic Patients2 trials

Coronary Artery Disease1 trial

Diabetes1 trial

Atherosclerosis1 trial

Combination Therapy1 trial

Tics1 trial

Lip1 trial

Efficacy and Safety1 trial

Chronic Kidney Disease1 trial

Inflammation1 trial

Pancreatic Cancer1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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