TheraRadar
Data updated: May 26, 2026

ACARBOSE

alpha Glucosidase Inhibitors
Metabolic Approved 2008-05-07

ACARBOSE is indicated for the treatment of Type 2 Diabetes.

Source: FDA Label • IMPAX LABS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
7
Indications
--
Phase 3 Trials
18
Years on Market

Details

Status
Prescription
First Approved
2008-05-07
Routes
ORAL
Dosage Forms
TABLET

Companies

IMPAX LABS AVET LIFESCIENCES STRIDES PHARMA HANGZHOU ZHONGMEI WATSON LABS Hikma SOMERSET THERAPS LLC NATCO PHARMA USA
Active Ingredient: ACARBOSE

ACARBOSE Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
54 FDA actions from 2008 to 2020
Aug 2020 ORIGINAL
Update
Oct 2019 SUPPL
Label · Labeling
Sep 2019 SUPPL
Label · Labeling

What ACARBOSE Treats

1 indications

ACARBOSE is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Type 2 Diabetes
Source: FDA Label

ACARBOSE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BRYNOVIN
AZURITY
2025 1 indic.
LIRAGLUTIDE
Fresenius Kabi
2024 1 indic.
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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 ACARBOSE's indications

See all emerging drugs →

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

Frexalimab SAR441344
Sanofi
CD40LG · monoclonal antibody (anti-CD40L, Fc-engineered to avoid platelet activation) · 4 Phase 3 trials

Drugs Similar to ACARBOSE

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Shared indications:
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Clinical Trial Registry

26 trials
Trial Sponsor ID Phase Status Title
NCT02953093 SAIL results posted 2016-6933 Ph 2 terminated Study of Acarbose in Longevity
NCT01514838 1941-CL-2003 Ph 3 terminated A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
NCT03380546 ACARB-GDM P150942 Ph 3 terminated Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.
NCT02589353 IRB # 5373 Ph 4 completed Human Oral Detection of Glucose Olygomers
NCT03794336 ACADEMIC ALOGLC08867 U1111-1210-0679 Ph 4 completed Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive
NCT03359837 SWITCH LANTUL07194 U1111-1186-3400 Ph 4 completed Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
NCT02836704 LANTUL07191 U1111-1172-2903 Ph 4 completed Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
NCT03344341 D1690C00060 Ph 4 terminated A Phase IV Study in Drug-Naive Patients With T2DM in China
NCT01914133 PPH H13-01316 G-13-0001812 Ph 2 completed Acarbose and Older Adults With Postprandial Hypotension
NCT02685852 1503M65841 Ph 1 completed Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia
NCT01490918 results posted ACADEMIC Ph 4 completed Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
NCT03349684 17886 Ph 3 completed Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
NCT01181674 results posted REMIT Pilot Control # 139433, 143584, 10-346 Ph 4 completed Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
NCT02072096 IMPERIUM results posted 14842 F3Z-MC-IOQL, 2013-001473-24 Ph 4 terminated A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)
NCT02865499 results posted HSC20120304 Ph 2 completed Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
NCT02049814 results posted BASCN1201 U1111-1147-3393, VOG-P4-001 Ph 4 completed Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes
NCT01709305 results posted 0431-313 Ph 4 completed A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
NCT01177384 results posted 0431-130 2010_543, CTRI/2011/10/002072 Ph 3 completed Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
NCT02315495 ISSSAXA0015 Ph 3 completed Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
NCT00829660 ACE 11232 ISRCTN91899513 Ph 4 completed Acarbose Cardiovascular Evaluation Trial
NCT02243176 SMART results posted D1680L00018 Ph 4 completed 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
NCT02143765 Match-101 ZhongdaH-Match Ph 4 completed Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus
NCT01839344 13A-1334 Ph 2 completed Effects of Quercetin on Blood Sugar and Blood Vessel Function in Type 2 Diabetes.
NCT02355509 REF.1467 Ph 4 completed Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients
NCT02211950 1224.22 Ph 1 completed Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers
NCT01030952 results posted CDJN608ACN07 Ph 4 completed Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
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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.

ACARBOSE FDA Label Details

Indications & Usage

ACARBOSE is indicated for the treatment of Type 2 Diabetes.

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Data Sources

FDA Approval: ANDA078441 → Label: DailyMed → Trials: ClinicalTrials.gov →

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