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 |
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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 |
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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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Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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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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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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