TheraRadar
Data updated: May 26, 2026

GLYSET (miglitol)

Metabolic Approved 1996-12-18
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
29
Years on Market

Details

Status
Discontinued
First Approved
1996-12-18
Routes
ORAL
Dosage Forms
TABLET

Companies

Pfizer
Active Ingredient: MIGLITOL

GLYSET Approval History

1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
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2015
2016
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2026
Original
New Indication
New Form
Label Update
24 FDA actions from 1996 to 2015 · 1 indication expansions
Oct 2015 SUPPL
Mfg · Manufacturing (CMC)
Sep 2012 SUPPL
Label · Labeling
FDA Letter Label
Apr 2009 SUPPL
Label · Labeling
FDA Letter Label

What GLYSET Treats

2 FDA approvals

Originally approved for its first indication in 1996 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01099839 1941-CL-0062 Ph 1 completed A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

GLYSET FDA Label Details

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Data Sources

FDA Approval: NDA020682 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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