Fudosteine
Fudosteine was first approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on Oct 1, 2001, then approved by China Food and Drug Administration (CFDA) on May 19, 2009. It was developed by and marketed as Cleanal® by Mitsubishi Tanabe Pharma in Japan.
Fudosteine is a novel mu coactive agent and a MUC5AC mucin hypersecretion inhibitor. It is indicated for use in patients with chronic respiratory diseases (bronchial asthma, chronic bronchitis, bronchiectasis, etc.)
Cleanal® is available as tablet for oral use, containing 200 mg of free Fudosteine. Generally, the recommended starting dose for adult is 400 mg three times daily after meal.
General Information
Update Date：2016-03-23
- Drug Name：
- Fudosteine
- Research Code：
- SS-320A
- Trade Name：
- Cleanal® / Spelear®
- MOA：
- MUC5AC mucin hypersecretion inhibitor
- Indication：
- Chronic respiratory diseases
- Status：
- Approved
- Company：
- Mitsubishi Tanabe (Originator)
- Sales：
- ATC Code：
- R03
Approved Countries or Area
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2001-10-01 | Marketing approval | Cleanal | Chronic respiratory diseases | Tablet | 200 mg | Mitsubishi Tanabe |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2014-05-18 | Marketing approval | Chronic respiratory diseases | Tablet | 0.2 g | 江苏正大丰海制药 | ||
| 2013-10-24 | Marketing approval | Chronic respiratory diseases | Tablet | 0.2 g | 宜昌长江药业 | 3.1类 | |
| 2013-09-02 | Marketing approval | Chronic respiratory diseases | Granule | 每袋0.4g | 正大青春宝药业 | 3.1类 | |
| 2013-09-02 | Marketing approval | Chronic respiratory diseases | Capsule | 0.2g | 正大青春宝药业 | 3.1类 | |
| 2013-08-29 | Marketing approval | Chronic respiratory diseases | Tablet | 0.2 g | 正大青春宝药业 | 3.1类 | |
| 2013-03-15 | Marketing approval | Chronic respiratory diseases | Tablet | 0.2 g | 四川科伦药业 | 3.1类 | |
| 2013-03-15 | Marketing approval | Chronic respiratory diseases | Capsule | 0.2 g | 四川科伦药业 | 3.1类 | |
| 2011-05-05 | Marketing approval | Chronic respiratory diseases | Tablet | 0.2 g | 迪沙药业 | 3.1类 | |
| 2010-04-29 | Marketing approval | Chronic respiratory diseases | Capsule | 0.2 g | 天方药业 | 3.1类 |
Chemical Structure
Update Date：2015-08-27
|
Molecular Weight | 179.24 | ||||||||||||
| Formula | C6H13NO3S | |||||||||||||
| CAS No. | 13189-98-5 (Fudosteine); | |||||||||||||
| Chemical Name | (-)-3-[(3-hydroxypropyl)thio]-L-alanine | |||||||||||||
| Fudosteine （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Synthesis & Impurities
Update Date：2016-06-22
