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Acarbose

Generic Name
Acarbose
Brand Names
Precose
Drug Type
Small Molecule
Chemical Formula
C25H43NO18
CAS Number
56180-94-0
Unique Ingredient Identifier
T58MSI464G

Overview

Acarbose is a complex oligosaccharide that acts as an inhibitor of several enzymes responsible for the breakdown of complex carbohydrates in the intestines. It inhibits both pancreatic alpha-amylase and membrane-bound alpha-glucosidases - including intestinal glucoamylase, sucrase, maltase, and isomaltase - which are responsible for the metabolism of complex starches and oligo-, tri-, and disaccharides into absorbable simple sugars. By inhibiting the activity of these enzymes, acarbose limits the absorption of dietary carbohydrates and the subsequent postprandial increase in blood glucose and insulin levels. Acarbose is therefore used in conjunction with diet, exercise, and other pharmacotherapies for the management of blood sugar levels in patients with type 2 diabetes. Acarbose is one of only two approved alpha-glucosidase inhibitors (the other being miglitol), receiving its first FDA approval in 1995 under the brand name Precose (since discontinued). This class of antidiabetic therapy is not widely used due to their relatively modest impact on A1c, their requirement for thrice-daily dosing, and the potential for significant gastrointestinal adverse effects.

Indication

Acarbose is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions

  • Type 2 Diabetes Mellitus

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2017/12/21
Phase 3
Terminated
2017/12/02
Phase 4
Completed
2017/11/21
Phase 3
Completed
2017/11/17
Phase 4
Terminated
2017/08/07
Not Applicable
Completed
University Hospital, Gentofte, Copenhagen
2016/12/21
Phase 4
UNKNOWN
Peking University
2016/11/02
Phase 2
Terminated
2016/08/12
Phase 2
Completed
2016/07/19
Phase 4
Completed
2016/02/19
Phase 1
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Virtus Pharmaceuticals LLC
69543-120
ORAL
25 mg in 1 1
5/31/2018
Bryant Ranch Prepack
71335-9725
ORAL
50 mg in 1 1
3/24/2022
Aiping Pharmaceutical
11788-041
ORAL
100 mg in 1 1
9/6/2020
A-S Medication Solutions
50090-4115
ORAL
50 mg in 1 1
1/2/2019
AvKARE
42291-131
ORAL
50 mg in 1 1
1/3/2024
Strides Pharma Science Limited
64380-759
ORAL
50 mg in 1 1
7/27/2022
Virtus Pharmaceuticals LLC
69543-121
ORAL
50 mg in 1 1
5/31/2018
Chartwell RX, LLC
62135-454
ORAL
50 mg in 1 1
2/2/2023
A-S Medication Solutions
50090-4952
ORAL
50 mg in 1 1
7/27/2022
Chartwell RX, LLC
62135-453
ORAL
25 mg in 1 1
2/2/2023

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Acarbose Tablets
国药准字H20213032
化学药品
片剂
1/19/2021
Acarbose Tablets
国药准字HJ20130906
化学药品
片剂
9/17/2020
Acarbose Tablets
国药准字H20223141
化学药品
片剂
3/16/2022
Acarbose Tablets
国药准字H20153002
化学药品
片剂
6/29/2020
Acarbose Tablets
国药准字H20223062
化学药品
片剂
1/30/2022
Acarbose Tablets
国药准字H20244515
化学药品
片剂
7/30/2024
Acarbose Tablets
国药准字H20244563
化学药品
片剂
7/30/2024
Acarbose Tablets
国药准字H20227010
化学药品
片剂
1/30/2022
Acarbose Tablets
国药准字H19990205
化学药品
片剂
11/5/2024
Acarbose Tablets
国药准字HJ20200027
化学药品
片剂
8/12/2020

PPB Drug Approvals

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Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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