GLUCOTROL XL (glipizide) · Pfizer
GLUCOTROL XL is FDA-approved to treat 1 condition (same as GLIPIZIDE).
Details
- Status
- Discontinued
- First Approved
- 1994-04-26
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
GLUCOTROL XL Approval History
What GLUCOTROL XL Treats
1 indicationsGLUCOTROL XL is approved for 1 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
Same approved indications as GLIPIZIDE (same active ingredient).
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01762046 SUGAR-MGH results posted | 2007p000193 | Ph 1 | completed | Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans |
| NCT06168812 | 23-318 | Ph 2 | active not recruiting | A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer |
| NCT01698775 results posted | 3102-019 2012-002332-85 | Ph 3 | completed | 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) |
| NCT00885352 results posted | 0431-128 2009_577 | Ph 3 | completed | Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128) |
| NCT01951651 results posted | H-26030 | Ph 4 | completed | Effect of Exenatide on Liver and Heart Fat and Inflammation |
| NCT00660907 results posted | D1690C00004 | Ph 3 | completed | Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients |
| NCT00856284 ENDURE results posted | SYR-322_305 2008-007444-34, U1111-1111-7397 | Ph 3 | completed | Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus |
| NCT00707993 results posted | SYR-322_303 2008-000959-10, U1111-1112-7905 | Ph 3 | completed | Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics |
| NCT01020123 results posted | D1020C00009 | Ph 2 | completed | Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GLUCOTROL XL FDA Label Details
Indications & Usage
FDA Label (PDF)GLUCOTROL XL is FDA-approved to treat 1 condition — same approved indications as GLIPIZIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.