Overview
Radium Ra 223 Dichloride is a radiopharmaceutical containing the radioisotope radium-223 that emits short range but high linear energy alpha particles. As a cation, radium mimics calicum and binds to hydroxyapatite, which is a bone mineral found in areas of high bone turnover as seen in bone metastases. It was first approved by the FDA in May 2013 and is currently marketed under the brand name Xofigo, which was formerly called Alpharadin. Xofigo is indicated in patients who have metastatic bone cancer that is symptomatic with no visceral metastases and patients who have prostate cancer that is castration resistant. The FDA label includes a warning that Radium Ra 223 Dichloride should not be used in women who are pregnant or may become pregnant due to the high risk of fetal harm.
Background
Radium Ra 223 Dichloride is a radiopharmaceutical containing the radioisotope radium-223 that emits short range but high linear energy alpha particles. As a cation, radium mimics calicum and binds to hydroxyapatite, which is a bone mineral found in areas of high bone turnover as seen in bone metastases. It was first approved by the FDA in May 2013 and is currently marketed under the brand name Xofigo, which was formerly called Alpharadin. Xofigo is indicated in patients who have metastatic bone cancer that is symptomatic with no visceral metastases and patients who have prostate cancer that is castration resistant. The FDA label includes a warning that Radium Ra 223 Dichloride should not be used in women who are pregnant or may become pregnant due to the high risk of fetal harm.
Indication
Used in patients who have metastatic bone cancer that is symptomatic with no visceral metastases and patients who have prostate cancer that is castration resistant.
Associated Conditions
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/07/28 | N/A | Recruiting | |||
2019/04/04 | Phase 3 | Recruiting | |||
2018/03/08 | Phase 3 | UNKNOWN | Amsterdam UMC, location VUmc | ||
2018/02/05 | N/A | Completed | |||
2017/12/11 | N/A | Completed | |||
2017/10/09 | Phase 2 | Completed | |||
2017/07/21 | N/A | Completed | |||
2017/02/23 | Phase 2 | Completed | Sir Mortimer B. Davis - Jewish General Hospital | ||
2016/09/16 | Phase 2 | Completed | |||
2016/09/14 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bayer HealthCare Pharmaceuticals Inc. | 50419-208 | INTRAVENOUS | 30 uCi in 1 mL | 5/24/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/13/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| XOFIGO SOLUTION FOR INJECTION 1100kBq/ML | SIN14478P | INJECTION, SOLUTION (RADIOPHARMACEUTICAL) | 1100 kBq/ml | 1/9/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XOFIGO radium (223Ra) dichloride 6.6 MBq per 6 mL solution for injection vial | 208905 | Medicine | A | 5/20/2014 |