Dasatinib Hydrate
Dasatinib hydrate was first approved by the U.S. Food and Drug Administration (FDA) on June 28, 2006, then approved by European Medicine Agency (EMA) on Nov 20, 2006, and approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on Jan 21, 2009. It was developed and marketed as Sprycel® by Bristol Myers Squibb in the US.
Dasatinibhydrate is a kinase inhibitor.It is indicated for the treatment ofchronic myeloid leukemia and acutelymphoblastic leukemia.
Sprycel® is available as film-coatedtabletfor oral use, containing 20, 50, 70, 80, 100 or 140 mg offreeDasatinib. The recommended dose is 100 mg once daily forchronic myeloid leukemia. Another dose is 140 mg once daily for accelerated phase chronic myeloid leukemia, myeloid or lymphoid blast phase chronic myeloid leukemia, or Ph+ acutelymphoblastic leukemia.
General Information
Update Date：2016-03-14
- Drug Name：
- Dasatinib Hydrate
- Research Code：
- BMS-354825
- Trade Name：
- Sprycel®
- MOA：
- Kinase inhibitor
- Indication：
- Acute lymphoblastic leukaemia (ALL); Chronic myeloid leukemia (CML )
- Status：
- Approved
- Company：
- Bristol-Myers Squibb (Originator)
- Sales：
-
$1,620 Million (Y2015);
$1,493 Million (Y2014);
$1,280 Million (Y2013);
$1,019 Million (Y2012);
$803 Million (Y2011); - ATC Code：
- L01XE06
Approved Countries or Area
Update Date：2016-03-09
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2006-06-28 | Marketing approval | Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet, Film coated | Eq. 20 mg/50 mg/70 mg/80 mg/100 mg/140 mg Dasatinib | Bristol-Myers Squibb | Priority; Orphan |
| 2006-06-28 | Additional approval | Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet, Film coated | 70 mg | Bristol-Myers Squibb | Priority |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2006-11-20 | Marketing approval | Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet, Film coated | 20 mg/50 mg/70 mg/80 mg/100 mg/140 mg | Bristol-Myers Squibb | Orphan |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2011-06-16 | Modified indication | Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet, Film coated | 20 mg/50 mg | Bristol-Myers Squibb, Otsuka | |
| 2009-01-21 | Marketing approval | Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet, Film coated | 20 mg/50 mg | Bristol-Myers Squibb, Otsuka |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2013-09-17 | Marketing approval | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 20 mg | 南京正大天晴制药 | ||
| 2013-09-17 | Marketing approval | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 50 mg | 南京正大天晴制药 | ||
| 2013-09-17 | Marketing approval | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 70 mg | 南京正大天晴制药 | ||
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 50 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 50 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 50 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 20 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 20 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 20 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 70 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 70 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 70 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 100 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 100 mg | Bristol-Myers Squibb | |
| 2011-09-07 | Marketing approval | 施达赛/Sprycel | Acute lymphoblastic leukaemia (ALL), Chronic myeloid leukemia (CML ) | Tablet | 100 mg | Bristol-Myers Squibb |
Chemical Structure
Update Date：2015-08-20
|
Molecular Weight | 506.02 | ||||||||||||
| Formula | C22H26ClN7O2S • H2O | |||||||||||||
| CAS No. |
302962-49-8 (Dasatinib ); 863127-77-9 (Dasatinib Monohydrate); |
|||||||||||||
| Chemical Name | N-(2-chloro-6methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5thiazolecarboxamide, monohydrate | |||||||||||||
| Dasatinib （Free Acid/Base）Parameters： | ||||||||||||||
|
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Related Patents
Update Date：2016-02-03
Synthesis & Impurities
Update Date：2016-06-01
