TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

GLIMEPIRIDE

GLIMEPIRIDE
Approved 2005-10-06
Jump to: Indications Approvals Trials Competitors Safety Patents
11
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Discontinued
First Approved
2005-10-06
Routes
ORAL
Dosage Forms
TABLET

Companies

Viatris QUAGEN PRINSTON INC Dr. Reddy's SENORES PHARMS RANBAXY LABS LTD REGCON HOLDINGS WATSON LABS MICRO LABS CARLSBAD ACCORD HLTHCARE Teva EPIC PHARMA LLC RANBAXY Hikma CHARTWELL MOLECULAR Aurobindo Pharma
Active Ingredient: GLIMEPIRIDE

GLIMEPIRIDE Approval History

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What GLIMEPIRIDE Treats

11 FDA approvals

Originally approved for its first indication in 2005 . Covers 11 distinct patient populations.

  • Other (11)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

GLIMEPIRIDE FDA Label Details

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Data Sources

FDA Approval: ANDA077486 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.