Radium Ra 223 dichloride

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.

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
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer	2020/07/28	NCT04489719	N/A	Recruiting	University of Washington
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer	2019/04/04	NCT03903835	Phase 3	Recruiting	Karolinska Institutet
Rhenium-188-HEDP vs. Radium-223-chloride in Patients With Advanced Prostate Cancer Refractory to Hormonal Therapy	2018/03/08	NCT03458559	Phase 3	UNKNOWN	Amsterdam UMC, location VUmc
Multi-academic Center Study of Xofigo Patients	2018/02/05	NCT03419442	N/A	Completed	Bayer
The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.	2017/12/11	NCT03368989	N/A	Completed	The University of Texas Health Science Center, Houston
Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone	2017/10/09	NCT03304418	Phase 2	Completed	University of Utah
Registry of Treatment Outcomes of Symptomatic Metastasized Castration Resistant Prostate Cancer Treated With Radium-223	2017/07/21	NCT03223597	N/A	Completed	The Netherlands Cancer Institute
Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy	2017/02/23	NCT03062254	Phase 2	Completed	Sir Mortimer B. Davis - Jewish General Hospital
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)	2016/09/16	NCT02903160	Phase 2	Completed	Icahn School of Medicine at Mount Sinai
Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )	2016/09/14	NCT02899104	N/A	Completed	Bayer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Xofigo	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
Xofigo	Bayer AG,51368 Leverkusen,Germany	Authorised	11/13/2013
Xofigo	Bayer AG,51368 Leverkusen,Germany	Authorised	11/13/2013

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
XOFIGO SOLUTION FOR INJECTION 1100kBq/ML	Agilera Pharma AS, Cardinal Health 414, LLC	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	Bayer Australia Ltd	Medicine	A	5/20/2014

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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