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.
Background
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 |
|---|---|---|---|---|---|
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 | ||
2017/12/26 | Phase 4 | UNKNOWN |
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 |
|---|---|---|---|---|---|
| Acarbose Capsules | 国药准字H20020391 | 化学药品 | 胶囊剂 | 5/18/2020 | |
| Acarbose Chewable Tablets | 国药准字H20150012 | 化学药品 | 片剂 | 7/5/2024 | |
| Acarbose Tablets | 国药准字H20213876 | 化学药品 | 片剂 | 11/17/2021 | |
| Acarbose Tablets | 国药准字H20253463 | 化学药品 | 片剂 | 2/25/2025 | |
| Acarbose Tablets | 生达化学制药股份有限公司 | 国药准字HC20240007 | 化学药品 | 片剂 | 10/16/2024 |
| Acarbose Tablets | 国药准字H20244564 | 化学药品 | 片剂 | 7/30/2024 | |
| Acarbose Tablets | 国药准字H20203311 | 化学药品 | 片剂 | 7/16/2020 | |
| Acarbose Tablets | 国药准字H20203563 | 化学药品 | 片剂 | 11/10/2020 | |
| Acarbose Tablets | 国药准字H20213948 | 化学药品 | 片剂 | 12/14/2021 | |
| Acarbose Tablets | 国药准字HJ20130907 | 化学药品 | 片剂 | 9/17/2020 |
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 |