Miglitol
- Generic Name
- Miglitol
- Drug Type
- Small Molecule
- Chemical Formula
- C8H17NO5
- CAS Number
- 72432-03-2
- Unique Ingredient Identifier
- 0V5436JAQW
Overview
Miglitol inhibits the breakdown complex carbohydrates into glucose. It is primarily used in diabetes mellitus type 2 for establishing greater glycemic control by preventing the digestion of carbohydrates (such as disaccharides, oligosaccharides, and polysaccharides) into monosaccharides which can be absorbed by the body. Miglitol should be taken at the start of a meal for maximal effect and the effect will depend on the amount of poly and oligosaccharides in the diet. Miglitol inhibits alpha-glucosidase, making less sugars available for digestion and reducing postprandial hyperglycemia. Unlike other drugs of the same class, miglitol is not metabolized and the unmetabolized drug is excreted by the kidneys.
Background
Miglitol inhibits the breakdown complex carbohydrates into glucose. It is primarily used in diabetes mellitus type 2 for establishing greater glycemic control by preventing the digestion of carbohydrates (such as disaccharides, oligosaccharides, and polysaccharides) into monosaccharides which can be absorbed by the body. Miglitol should be taken at the start of a meal for maximal effect and the effect will depend on the amount of poly and oligosaccharides in the diet. Miglitol inhibits alpha-glucosidase, making less sugars available for digestion and reducing postprandial hyperglycemia. Unlike other drugs of the same class, miglitol is not metabolized and the unmetabolized drug is excreted by the kidneys.
Indication
For use as an adjunct to diet to improve glycemic control in patients with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be managed with diet alone.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/04/08 | Phase 1 | Completed | |||
2006/09/27 | Phase 3 | Completed | |||
2006/06/07 | Phase 3 | Completed | |||
2006/06/07 | Phase 3 | Completed | |||
2005/09/21 | Phase 3 | Completed | |||
2005/09/21 | Phase 3 | Completed | |||
2005/09/21 | Phase 3 | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
Miglitol | Proficient Rx LP | ORAL | 100 mg in 1 1 | 2022/04/01 | 71205-937 |
Miglitol | Proficient Rx LP | ORAL | 50 mg in 1 1 | 2022/04/01 | 71205-936 |
Miglitol | Westminster Pharmaceuticals, LLC | ORAL | 50 mg in 1 1 | 2021/12/07 | 69367-304 |
Miglitol | Westminster Pharmaceuticals, LLC | ORAL | 100 mg in 1 1 | 2021/12/07 | 69367-305 |
Miglitol | Westminster Pharmaceuticals, LLC | ORAL | 25 mg in 1 1 | 2021/12/07 | 69367-303 |
Miglitol | Orient Pharma Co., Ltd. | ORAL | 25 mg in 1 1 | 2019/10/23 | 76333-125 |
Miglitol | Orient Pharma Co., Ltd. | ORAL | 50 mg in 1 1 | 2019/10/23 | 76333-126 |
Miglitol | Orient Pharma Co., Ltd. | ORAL | 100 mg in 1 1 | 2019/10/23 | 76333-127 |
Miglitol | Proficient Rx LP | ORAL | 25 mg in 1 1 | 2022/04/01 | 71205-935 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. | Online |
|---|
No Singapore products found
No Singapore products found for this drug
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
Miglitol Orally Disintegrating Tablets | 国药准字H20223109 | 浙江医药股份有限公司新昌制药厂 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2022/03/08 | Domestic |
Miglitol Orally Disintegrating Tablets | 国药准字H20223108 | 浙江医药股份有限公司新昌制药厂 | 片剂 | N/A | 25mg | Chemical Drug | Approved | 2022/03/08 | Domestic |
Miglitol Tablets | 国药准字H20227099 | 浙江医药股份有限公司新昌制药厂 | 片剂 | N/A | 25mg | Chemical Drug | Approved | 2022/09/01 | Domestic |
Miglitol Tablets | 国药准字H20113504 | 山东新时代药业有限公司 | 片剂 | N/A | 25mg | Chemical Drug | Approved | 2022/11/29 | Domestic |
Miglitol Tablets | 国药准字H20113503 | 山东新时代药业有限公司 | 片剂 | N/A | 100mg | Chemical Drug | Approved | 2022/11/29 | Domestic |
Miglitol Tablets | 国药准字H20045403 | 四川维奥制药有限公司 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2020/04/26 | Domestic |
Miglitol Tablets | 国药准字H20083446 | 山东新时代药业有限公司 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2022/11/29 | Domestic |
Miglitol Tablets | 国药准字H20074195 | 浙江医药股份有限公司新昌制药厂;浙江创新生物有限公司 | 片剂 | N/A | 50mg | Chemical Drug | Approved | 2022/08/05 | Domestic |
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|
No Australia products found
No Australia products found for this drug