MedPath

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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/14
Not Applicable
Not yet recruiting
Haisco Pharmaceutical Group Co., Ltd.
2022/11/29
Phase 3
Recruiting
2022/09/16
Phase 4
Completed
AgelessRx
2022/08/04
Phase 2
Not yet recruiting
2020/02/27
Phase 4
UNKNOWN
2019/11/29
N/A
Terminated
2019/08/22
Phase 1
Completed
2019/05/23
Not Applicable
UNKNOWN
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2019/01/07
Phase 4
Completed
2018/07/27
Phase 4
UNKNOWN
Chinese PLA General Hospital

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Hikma Pharmaceuticals USA Inc.
0054-0142
ORAL
100 mg in 1 1
6/1/2021
Strides Pharma Science Limited
64380-760
ORAL
100 mg in 1 1
7/27/2022
Proficient Rx LP
71205-856
ORAL
100 mg in 1 1
5/1/2022
A-S Medication Solutions
50090-5829
ORAL
100 mg in 1 1
12/26/2019
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-147
ORAL
25 mg in 1 1
3/24/2022
Physicians Total Care, Inc.
54868-5831
ORAL
25 mg in 1 1
5/23/2012
Aphena Pharma Solutions - Tennessee, LLC
43353-951
ORAL
50 mg in 1 1
6/13/2014
Hikma Pharmaceuticals USA Inc.
0054-0141
ORAL
50 mg in 1 1
6/1/2021
Proficient Rx LP
71205-855
ORAL
50 mg in 1 1
5/1/2022
Physicians Total Care, Inc.
54868-5945
ORAL
25 mg in 1 1
11/9/2010

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
GARBOSE TABLET 50MG
SIN15816P
TABLET
50mg
9/20/2019
GLUCOBAY 100 TABLET 100 mg
SIN07862P
TABLET
100 mg
10/1/1994
GARBOSE TABLET 100MG
SIN15815P
TABLET
100mg
9/20/2019
GLUCOBAY 50 TABLET 50 mg
SIN07861P
TABLET
50 mg
10/1/1994

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
TAGLU FILM-COATED TAB 100MG
N/A
wings pharmaceutical ltd
N/A
N/A
11/12/2012

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
GLUCOBAY
Bayer Inc
02190885
Tablet - Oral
50 MG
2/2/1996
MAR-ACARBOSE
marcan pharmaceuticals inc
02494078
Tablet - Oral
50 MG
2/5/2020
GLUCOBAY
Bayer Inc
02190893
Tablet - Oral
100 MG
2/2/1996
MINT-ACARBOSE
mint pharmaceuticals inc
02493799
Tablet - Oral
100 MG
5/28/2020
MAR-ACARBOSE
marcan pharmaceuticals inc
02494086
Tablet - Oral
100 MG
2/5/2020
MINT-ACARBOSE
mint pharmaceuticals inc
02493780
Tablet - Oral
50 MG
5/28/2020

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
GLUCOBAY 100 mg COMPRIMIDOS
Bayer Hispania S.L.
59420
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
GLUCOBAY 50 mg COMPRIMIDOS
Bayer Hispania S.L.
59419
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
ACARBOSA TECNIGEN 100 mg COMPRIMIDOS
Tecnimede España Industria Farmaceutica S.A.
70452
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
ACARBOSA QUALIGEN 50 mg COMPRIMIDOS
Neuraxpharm Spain S.L.
75316
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
ACARBOSA FARMALIDER 50 MG COMPRIMIDOS
Farmalider S.A.
76586
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
ACARBOSA FARMALIDER 100 MG COMPRIMIDOS
Farmalider S.A.
76587
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized
ACARBOSA VIATRIS 100 MG COMPRIMIDOS
71443
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
ACARBOSA VIATRIS 50 MG COMPRIMIDOS
71442
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
ACARBOSA TECNIGEN 50 mg COMPRIMIDOS
Tecnimede España Industria Farmaceutica S.A.
70451
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Commercialized
ACARBOSA QUALIGEN 100 mg COMPRIMIDOS
Neuraxpharm Spain S.L.
75315
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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