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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
GLARBOSE acarbose 100 mg tablet blister pack | 226798 | Medicine | A | 5/14/2015 | |
ACARBOSE VIATRIS acarbose 100 mg tablet blister pack | 226797 | Medicine | A | 5/14/2015 | |
GLARBOSE acarbose 50 mg tablet blister pack | 226790 | Medicine | A | 5/14/2015 | |
GLYBOSAY acarbose 100 mg tablet blister pack | 226791 | Medicine | A | 5/14/2015 | |
ACARBOSE GPPL acarbose 50 mg tablet blister pack | 226793 | Medicine | A | 5/14/2015 | |
GLYBOSAY acarbose 50 mg tablet blister pack | 226792 | Medicine | A | 5/14/2015 | |
ACARBOSE-WGR acarbose 100 mg tablet blister pack | 226794 | Medicine | A | 5/14/2015 | |
ACARBOSE GPPL acarbose 100 mg tablet blister pack | 226789 | Medicine | A | 5/14/2015 | |
ACARBOSE-WGR acarbose 50 mg tablet blister pack | 226795 | Medicine | A | 5/14/2015 | |
ACARBOSE VIATRIS acarbose 50 mg tablet blister pack | 226796 | Medicine | A | 5/14/2015 |
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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