Data updated: Jul 17, 2026
GLYBURIDE (MICRONIZED) (glyburide) · Teva
Metabolic
Approved 1992-04-17
GLYBURIDE (MICRONIZED) is FDA-approved to treat 1 condition (same as GLYBURIDE).
Source: FDA Label
6
Indications
--
Phase 3 Trials
34
Years on Market
Details
- Status
- Prescription
- First Approved
- 1992-04-17
- Routes
- ORAL
- Dosage Forms
- TABLET
GLYBURIDE (MICRONIZED) Approval History
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Original
New Indication
New Form
Label Update
170 FDA actions from 1992 to 2021
Mar 2021 SUPPL
Label · Labeling
Oct 2019 SUPPL
Label · Labeling
Jan 2016 SUPPL
Label · Labeling
Oct 2015 SUPPL
Label
Sep 2015 SUPPL
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Apr 2015 SUPPL
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Feb 2015 SUPPL
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Mar 2014 SUPPL
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Sep 2012 SUPPL
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Aug 2011 SUPPL
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Aug 2011 SUPPL
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Apr 2010 SUPPL
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May 2009 SUPPL
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May 2009 SUPPL
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Mar 2009 SUPPL
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Oct 2002 SUPPL
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Jul 2002 SUPPL
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Sep 2001 SUPPL
Label
Aug 2001 SUPPL
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Sep 2000 SUPPL
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Aug 2000 SUPPL
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Mar 2000 SUPPL
Label
Mar 2000 SUPPL
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Feb 2000 SUPPL
Label
Aug 1999 SUPPL
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Feb 1999 SUPPL
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Dec 1998 SUPPL
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Dec 1997 SUPPL
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Dec 1997 ORIGINAL
Update
May 1997 SUPPL
Mfg
Feb 1995 SUPPL
Mfg
Feb 1995 SUPPL
Label
Apr 1992 ORIGINAL
New Form
What GLYBURIDE (MICRONIZED) Treats
1 indicationsGLYBURIDE (MICRONIZED) is approved for 1 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as GLYBURIDE (same active ingredient).
Source: FDA Label
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01329016 GDM | 820 | Ph 1, Ph 2 | completed | Glyburide and Metformin for Gestational Diabetes Mellitus (GDM) |
| NCT01731431 INDAO | P110104 | Ph 3 | completed | Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes |
| NCT03029702 MATCh-GDM results posted | PRO16100499 K23HD092893 | Ph 4 | completed | Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus |
| NCT01454154 | RPI 202 INTRuST-GLY | Ph 2 | completed | Glyburide (RP-1127) for Traumatic Brain Injury (TBI) |
| NCT02460874 results posted | IRB-16063003 | Ph 1, Ph 2 | terminated | Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593) |
| NCT02524379 SCING results posted | 2014H0335 | Ph 1, Ph 2 | terminated | Spinal Cord Injury Neuroprotection With Glyburide |
| NCT00744965 results posted | 032011-086 042008-058 | Ph 4 | completed | Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo |
| NCT03856970 | C3718-103 | Ph 1 | completed | Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers |
| NCT03078725 GLAM | HSC-MS-16-1052 | Ph 4 | withdrawn | Failure Rate of GLyburide And Metformin Among Gestational Diabetics |
| NCT02815787 | QLHCPI-179 | Ph 1 | completed | The Drug -Drug Interaction of SP2086 and Glyburide |
| NCT01947699 | UPMC_GLY_GDM | Ph 4 | withdrawn | Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide |
| NCT00935363 | GlyburideOATP2C9 | Ph 1 | withdrawn | Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK) |
| NCT01716338 | A-15112.b | Ph 1 | completed | Glyburide Healthy Volunteer Study |
| NCT02183428 | 1218.30 | Ph 1 | completed | Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers |
| NCT01456650 | INNSZ-ABCA1 | Ph 4 | completed | R230C and C230C Variants of ABCA1 and Glyburide Response |
| NCT01733108 | CR014872 28431754DIA1004 | Ph 1 | completed | A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers |
| NCT01029795 results posted | 13272 I2Q-MC-GMAJ | Ph 2 | terminated | A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
GLYBURIDE (MICRONIZED) FDA Label Details
Indications & Usage
GLYBURIDE (MICRONIZED) is FDA-approved to treat 1 condition — same approved indications as GLYBURIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.