Abiraterone Acetate
Abiraterone acetate was first approved by the U.S. Food and Drug Administration (FDA) on April 28, 2011, then approved by European Medicine Agency (EMA) on September 5, 2011, and approved by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on July 4, 2014. It was developed by Johnson & Johnson and marketed as Zytiga® by Johnson & Johnson in the US and EU, and by Johnson & Johnson and AstraZeneca in Japan.
Abiraterone acetate is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
Zytiga® is available as tablet for oral use, containing 250 mg of free Abiraterone. The recommended dose is 1000 mg once daily in combination with prednisone 5 mg twice daily on an empty stomach.
Update Date：2016-03-08
- Drug Name：
- Abiraterone Acetate
- Research Code：
- CB-7630
- Trade Name：
- Zytiga®
- MOA：
- CYP17 inhibitor
- Indication：
- Metastatic castration-resistant prostate cancer (mCRPC)
- Status：
- Approved
- Company：
- Johnson & Johnson (Originator)
- Sales：
-
$2,231 Million (Y2015);
$2,237 Million (Y2014);;
$1,698 Million (Y2013);;
$961 Million (Y2012);;
$301 Million (Y2011); - ATC Code：
- L02BX03
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2011-04-28 | Marketing approval | Zytiga | Metastatic castration-resistant prostate cancer (mCRPC) | Tablet | 250 mg | Johnson & Johnson | Priority |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2011-09-05 | Marketing approval | Zytiga | Metastatic castration-resistant prostate cancer (mCRPC) | Tablet | 250 mg | Janssen |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2014-07-04 | Marketing approval | Zytiga | Metastatic castration-resistant prostate cancer (mCRPC) | Tablet | 250 mg | Janssen, AstraZeneca |
Update Date：2015-08-27
|
Molecular Weight | 391.55 | ||||||||||||
| Formula | C26H33NO2 | |||||||||||||
| CAS No. | 154229-18-2 (Abiraterone Acetate); | |||||||||||||
| Chemical Name | (3β)17-(3-pyridinyl) androsta-5,16-dien-3-yl acetate | |||||||||||||
| Abiraterone Acetate （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Update Date：2015-11-17
Update Date：2015-10-21
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