Bicalutamide
Bicalutamide was first approved on Feb 23, 1995 in GB, then approved by the U.S. Food and Drug Administration (FDA) on Oct 4, 1995, and approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on Mar 12, 1999. It was developed and marketed as Casodex® by AstraZeneca (AZ).
Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Casodex® is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of stage D2 metastatic carcinoma of the prostate. Casodex® 150 mg daily is not approved for use alone or with other treatments.
Casodex® is available as tablet for oral use, containing 50 mg of free Bicalutamide. The recommended adult dose is one 50 mg tablet once daily (morning or evening) in combination with an LHRH analog.
Update Date：2016-03-14
- Drug Name：
- Bicalutamide
- Research Code：
- ICI-176334; ZD-176334
- Trade Name：
- Casodex®
- MOA：
- Androgen receptor inhibitor
- Indication：
- Metastatic prostate carcinoma
- Status：
- Approved
- Company：
- AstraZeneca (Originator)
- Sales：
-
$267 Million (Y2015);
$320 Million (Y2014);;
$376 Million (Y2013);;
$454 Million (Y2012);;
$550 Million (Y2011); - ATC Code：
- L02BB03
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 1995-10-04 | First approval | Casodex | Metastatic prostate carcinoma | Tablet | 50 mg | AstraZeneca |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2013-08-15 | New dosage form | Casodex | Metastatic prostate carcinoma | Tablet, Orally disintegrating | 80 mg | AstraZeneca | |
| 1999-03-12 | First approval | Casodex | Metastatic prostate carcinoma | Tablet | 80 mg | AstraZeneca |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2014-09-24 | Marketing approval | 康士得/Casodex | Metastatic prostate carcinoma | Tablet | 50 mg | AstraZeneca | |
| 2013-10-09 | Marketing approval | 康士得 | Metastatic prostate carcinoma | Tablet | 150 mg | AstraZeneca | |
| 2013-01-17 | Marketing approval | 康士得/Casodex | Metastatic prostate carcinoma | Tablet | 150 mg | AstraZeneca | |
| 2012-09-25 | Marketing approval | Metastatic prostate carcinoma | Tablet | 50 mg | 浙江海正药业 | ||
| 2011-12-31 | Marketing approval | Metastatic prostate carcinoma | Tablet | 50 mg | 上海复旦复华药业 | 6类 | |
| 2011-08-04 | Marketing approval | Metastatic prostate carcinoma | Tablet | 50 mg | 上海朝晖药业 | 6类 | |
| 2010-09-19 | Marketing approval | 岩列舒 | Metastatic prostate carcinoma | Capsule | 50 mg | 山西振东制药 | 5类 |
| 2010-08-24 | Marketing approval | 康士得 | Metastatic prostate carcinoma | Tablet | 50 mg | AstraZeneca |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 1995-02-23 | First approval | Casodex | Metastatic prostate carcinoma | Tablet | 50 mg | AstraZeneca |
Update Date：2015-08-27
|
Molecular Weight | 430.37 | ||||||||||||
| Formula | C18H14F4N2O4S | |||||||||||||
| CAS No. | 90357-06-5 (Bicalutamide); | |||||||||||||
| Chemical Name | (RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide | |||||||||||||
| Bicalutamide （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Update Date：2015-10-16
1. US2006041161A1.