TheraRadar
Data updated: May 26, 2026

MIGLITOL

alpha Glucosidase Inhibitors
Metabolic Approved 2015-02-24

Miglitol helps adults with type 2 diabetes manage their blood sugar levels alongside diet and exercise. It is primarily used to lower blood sugar spikes that occur after eating, providing an additional layer of control for patients who need help managing their glucose. This medication can be used alone or combined with other therapies like sulfonylureas to improve overall glycemic management.

Source: FDA Label • ORIENT PHARMA • alpha-Glucosidase Inhibitor

How MIGLITOL Works

This drug works by reversibly blocking enzymes in the small intestine that break down complex sugars into simple glucose. By slowing this digestive process, it delays the absorption of sugar into the bloodstream, which prevents sharp rises in blood glucose after meals. Unlike some other diabetes medications, it achieves this without stimulating the body to produce more insulin.

Source: FDA Label
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2015-02-24
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: MIGLITOL

MIGLITOL Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2015 to 2015
Feb 2015 ORIGINAL
Update

What MIGLITOL Treats

1 indications

MIGLITOL is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Type 2 Diabetes
Source: FDA Label

MIGLITOL Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in MIGLITOL's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MIGLITOL treats. First-in-class if their pivotal trials read out positive.

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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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Key Completed Trials

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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.

MIGLITOL FDA Label Details

Indications & Usage

MIGLITOL is indicated for the treatment of Type 2 Diabetes.

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Data Sources

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