Mitiglinide Calcium Hydrate
Mitiglinide calcium hydrate was approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on January 29, 2004. It was co-developed and co-marketed as Glufast® by Takeda and Kissei in Japan.
Mitiglinide is a rapid-acting insulin secretion-stimulating agent. It stimulates insulin secretion by closing the ATP-sensitive K+ (ATP) channels in pancreatic beta-cells. It is indicated for the treatment of type 2 diabetes mellitus.
Glufast® is available as tablet for oral use, containing 5 mg or 10 mg of Mitiglinide calcium hydrate. The recommended dose is 10 mg three times daily just before each meal (within 5 minutes).
General Information
Update Date：2016-05-16
- Drug Name：
- Mitiglinide Calcium Hydrate
- Research Code：
- KAD-1229
- Trade Name：
- Glufast®
- MOA：
- K+(ATP) channels blocker
- Indication：
- Type 2 diabetes
- Status：
- Approved
- Company：
- Kissei (Originator) , Takeda
- Sales：
-
$32.2 Million (Y2015);
$28.4 Million (Y2014);
$33.1 Million (Y2013);
$36.7 Million (Y2012);
$52.4 Million (Y2011); - ATC Code：
- A10BX08
Approved Countries or Area
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2004-01-29 | Marketing approval | Glufast | Type 2 diabetes | Tablet | 5 mg/10 mg | Kissei, Takeda |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2014-11-25 | Marketing approval | 快如妥/Glufast | Type 2 diabetes | Tablet | 5 mg | Kissei | |
| 2014-11-25 | Marketing approval | 快如妥/Glufast | Type 2 diabetes | Tablet | 10 mg | Kissei | |
| 2014-11-25 | Marketing approval | 快如妥/Glufast | Type 2 diabetes | Tablet | 10 mg | Kissei | |
| 2014-11-25 | Marketing approval | 快如妥/Glufast | Type 2 diabetes | Tablet | 5 mg | Kissei | |
| 2014-01-21 | Marketing approval | 法艾斯 | Type 2 diabetes | Capsule | 10 mg | 福州闽海药业 | |
| 2013-08-26 | Marketing approval | 法迪 | Type 2 diabetes | Tablet | 5 mg | 江苏正大天晴 | |
| 2013-08-26 | Marketing approval | 法迪 | Type 2 diabetes | Tablet | 10 mg | 江苏正大天晴 | Type 2 diabetes |
| 2012-12-31 | Marketing approval | Type 2 diabetes | Tablet | 5 mg | 正大青春宝药业 | ||
| 2012-12-31 | Marketing approval | Type 2 diabetes | Tablet | 10 mg | 正大青春宝药业 | ||
| 2012-02-10 | Marketing approval | Type 2 diabetes | Tablet | 10 mg | 辽宁华瑞联合制药 | ||
| 2012-02-10 | Marketing approval | Type 2 diabetes | Tablet | 5 mg | 辽宁华瑞联合制药 | ||
| 2010-08-31 | Marketing approval | Type 2 diabetes | Tablet | 10 mg | Hansoh | ||
| 2010-04-19 | Marketing approval | 快如妥/Glufast | Type 2 diabetes | Tablet | 10 mg | Kissei | |
| 2010-04-19 | Marketing approval | 快如妥/Glufast | Type 2 diabetes | Tablet | 5 mg | Kissei |
Chemical Structure
Update Date：2015-09-15
|
Molecular Weight | 704.91 | ||||||||||||
| Formula | C38H48N2O6 • Ca • 2H2O | |||||||||||||
| CAS No. |
145375-43-5 (Mitiglinide ); 207844-01-7 (Mitiglinide Calcium Dihydrate); |
|||||||||||||
| Chemical Name | (+)-Monocalcium bis[(2S ,3a,7a-cis)-α-benzylhexahydro-γ-oxo-2-isoindolinebutyrate]dihydrate | |||||||||||||
| Mitiglinide （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Synthesis & Impurities
Update Date：2015-12-25
