Radium-223 dichloride
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Xofigo | — | 2013-11-13 | europa.eu ↗ |
| Approved | US (FDA) | XOFIGO | — | 2013-05-15 | fda.gov ↗ |
Trials 56 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03208712 | Nov 2017 → Aug 2018 | urothelial carcinoma | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT04521361 | Nov 2020 → Oct 2023 | prostate carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04109729 | Sep 2020 → Apr 2026 overdue | castration-resistant prostate carcinoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03996473 | Mar 2020 → Apr 2021 | non-small cell lung carcinoma | Bayer | Terminated | No outcome recorded |
| Phase 1 | NCT02814669 | Sep 2016 → Jul 2019 | castration-resistant prostate carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02442063 | Aug 2015 → Oct 2016 | disease of bone structure, neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02406521 | Apr 2015 → Dec 2017 | renal cell carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02396368 | Mar 2015 → Jul 2017 | prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Withdrawn | No outcome recorded |
| Phase 1 | NCT01565746 | Mar → Oct 2012 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00748046 | Aug 2008 → Oct 2009 | metastatic neoplasm, prostate cancer | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT00667537 | Jul 2007 → Dec 2008 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT05383079 | Sep 2022 → Aug 2026 overdue | prostate carcinoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02928029 | Feb 2017 → Mar 2019 | plasma cell myeloma | Bayer | Terminated | No outcome recorded |
| Phase 1/2 | NCT02605356 | Oct 2016 → Nov 2019 | plasma cell myeloma | Bayer | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02880943 | Oct 2016 → Oct 2020 | clear cell renal carcinoma, metastatic carcinoma in the bone | Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie | Unknown | No outcome recorded |
| Phase 1/2 | NCT01934790 | Dec 2013 → Jun 2015 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1/2 | NCT01833520 | Oct 2013 → Apr 2020 | sarcoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01106352 | Jul 2010 → Jun 2015 | castration-resistant prostate carcinoma, metastatic carcinoma in the bone | Bayer | Completed | No outcome recorded |
| Phase 229 trials | ||||||
| Phase 2 | NCT05924672 | Aug 2024 → Jan 2026 overdue | castration-resistant prostate carcinoma, metastatic carcinoma in the bone | University of California, San Francisco | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04704505 | Apr 2022 → Feb 2028 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT04206319 | Sep 2020 → Feb 2026 overdue | prostate carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04037358 | Aug 2019 → Jul 2025 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT03062254 | Mar 2018 → Jul 2020 | prostate cancer | Sir Mortimer B. Davis - Jewish General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03304418 | Feb 2018 → Sep 2022 | metastatic prostate carcinoma | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT03230734 | Sep 2017 → Jul 2025 overdue | castration-resistant prostate carcinoma | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03093428 | Jun 2017 → Apr 2020 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02903160 | Jan 2017 → Nov 2021 | prostate cancer | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT03002220 | Dec 2016 → May 2020 | prostate cancer | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT02582749 | Apr 2016 → Sep 2017 | metastatic carcinoma in the bone, prostate cancer | Ajjai Alva, MD | Terminated | No outcome recorded |
| Phase 2 | NCT02463799 | Feb 2016 → Dec 2019 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT02283749 | Sep 2015 → Jul 2018 | non-small cell lung carcinoma | Angela Taber MD | Completed | No outcome recorded |
| Phase 2 | NCT02258451 | Jun 2015 → Jan 2020 | breast cancer | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT02225704 | Jun 2015 → Jul 2017 | prostate cancer | Cancer Trials Ireland | Completed | No outcome recorded |
| Phase 2 | NCT02346526 | Apr 2015 → Oct 2019 | castration-resistant prostate carcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02258464 | Mar 2015 → Aug 2019 | breast cancer | Bayer | Terminated | No outcome recorded |
| Phase 2 | NCT02366130 | Feb 2015 → Dec 2020 | breast cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02484339 | Dec 2014 → Dec 2016 | prostate carcinoma | University Hospital Freiburg | Unknown | No outcome recorded |
| Phase 2 | NCT02278055 | Oct 2014 → Feb 2022 | metastatic prostate carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02199197 | Jun 2014 → Apr 2018 | prostate cancer | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT02023697 | Mar 2014 → Mar 2017 | prostate cancer | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT02034552 | Mar 2014 → Jul 2016 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT02097303 | Mar 2014 → Dec 2015 | prostate cancer | Carolina Research Professionals, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01929655 | Sep 2013 → May 2017 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT01070485 | Jan 2010 → Mar 2011 | breast cancer, metastatic carcinoma in the bone | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00337155 | May 2006 → Dec 2008 | metastatic neoplasm, prostate cancer | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00667199 | May 2005 → Apr 2008 | hormone-resistant prostate carcinoma, metastatic carcinoma in the bone | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00459654 | Feb 2004 → May 2006 | metastatic neoplasm, prostate cancer | Bayer | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05771896 | Sep 2023 → Dec 2028 | metastatic prostate carcinoma | GenesisCare USA | Withdrawn | No outcome recorded |
| Phase 3 | NCT03574571 | Jun 2018 → Apr 2027 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02043678 | Mar 2014 → Feb 2018 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01810770 | Mar 2013 → Sep 2017 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT01618370 | Jul 2012 → Aug 2014 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00699751 | Jun 2008 → Jul 2011 | hormone-resistant prostate carcinoma, metastatic carcinoma in the bone | Bayer | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04597125 | Nov 2020 → Nov 2025 overdue | prostate carcinoma | Bayer | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02135484 | Sep 2014 → Nov 2020 | prostate cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01516762 | — | prostate neoplasm | Bayer | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02204943 Background | May 2015 → Jul 2017 | castration-resistant prostate carcinoma | Duke University | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07611110 Comparator | May 2026 → Feb 2029 expected | prostate carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT04237584 Comparator | Jun 2020 → Mar 2022 | castration-resistant prostate carcinoma | MANA RBM | Terminated | No outcome recorded |
| Phase 3 | NCT03903835 Comparator | Feb 2019 → Dec 2026 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Karolinska Institutet | Recruiting | No outcome recorded |
| Phase 3 | NCT03458559 Comparator | May 2018 → May 2022 | metastatic prostate carcinoma | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03432949 Background | Feb 2018 → Sep 2023 | metastatic prostate carcinoma | University Health Network, Toronto | Unknown | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Radium-223 dichloride | “Radium-223 dichloride is a radiopharmaceutical with structural similarity to calcium, allowing it to be taken up by bone where it emits alpha particles, and therefore might...” PMID 32487038 ↗ Jun 202028“Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections” NCT02582749 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01106352 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT04521361 ↗ |
| Known as | 223Ra | “Lutetium-177 [177Lu]Lu-PSMA-I&T (177Lu-PSMA-I&T) and the bone-seeking α-emitter radium-223 (223Ra) are established life-extending therapies” PMID 41119954 ↗ Oct 20252“²²³Ra-Dichloride (²²³Ra) is a novel bone-seeking alpha-emitter” PMID 23653243 ↗ May 2013 “up to six doses of 223Ra (55 kBq/kg of body weight per month)” PMID 35981452 ↗ Aug 2022 |
| Known as | 223Ra-chloride | “Quantitative imaging of 223Ra-chloride (Alpharadin) for targeted alpha-emitting radionuclide therapy of bone metastases.” PMID 22513884 ↗ Jul 2012 |
| Known as | 223Ra-Dichloride | “A Phase 1, Open-Label Study of the Biodistribution, Pharmacokinetics, and Dosimetry of 223Ra-Dichloride in Patients with Hormone-Refractory Prostate Cancer and Skeletal Metastases.” PMID 26182965 ↗ Jul 20151“²²³Ra-Dichloride (²²³Ra) is a novel bone-seeking alpha-emitter” PMID 23653243 ↗ May 2013 |
| Known as | Alpharadin | “Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases” NCT01618370 ↗3“Quantitative imaging of 223Ra-chloride (Alpharadin) for targeted alpha-emitting radionuclide therapy of bone metastases.” PMID 22513884 ↗ Jul 2012 “Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection.” NCT01106352 ↗ “Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer” NCT00667199 ↗ |
| Known as | BAY88-8223 | “Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases.” PMID 27272279 ↗ Jun 201624“Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 1” NCT00337155 ↗ “Radium-223 chloride (Xofigo®, BAY88-8223) injection” NCT00667537 ↗ “Radium Ra 223 dichloride (Xofigo, BAY88-8223)” NCT02442063 ↗ “Radium-223 dichloride (Xofigo, BAY 88-8223)” NCT03996473 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02258451 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT04521361 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT00699751 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01106352 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT00459654 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02605356 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01810770 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02043678 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01565746 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02928029 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01934790 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01929655 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02258464 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02023697 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT04597125 ↗ “Radium-223 dichloride (BAY88-8223)” NCT00667199 ↗ “Radium-223 dichloride (BAY88-8223)” NCT01618370 ↗ “Radium-223 dichloride (BAY88-8223)” NCT01516762 ↗ “Radium-223 chloride (BAY88-8223)” NCT01070485 ↗ “Radium-223 chloride (BAY88-8223)” NCT00748046 ↗ |
| Known as | Ra-223 Cl2 | “This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate...” NCT01618370 ↗ |
| Known as | Ra-223 dichloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02366130 ↗ |
| Known as | Ra223 | “We hypothesized the BM-targeting alpha-emitter radium-223 dichloride (Ra223) could target subclinical bone disease and delay progression.” PMID 40334149 ↗ May 2025 |
| Known as | Radium Chloride Ra-223 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03903835 ↗ |
| Known as | Radium Ra 223 dichloride | “Radium Ra 223 dichloride (Xofigo®, formerly Alpharadin) is one of the representative α-particle-emitting isotopes” PMID 23977665 ↗ Aug 20135“Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug.” NCT02396368 ↗ |
| Known as | radium-223 | “The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.” NCT02135484 ↗25“Radium 223 is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with pH between 6 and 8.” NCT02396368 ↗ “Radium-223 is an alpha-particle-emitting bone-targeted therapy.” NCT04704505 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01934790 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01565746 ↗ “Radium-223 dichloride (BAY88-8223)” NCT01618370 ↗ |
| Known as | Radium-223 chloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01070485 ↗ |
| Known as | Xofigo | “Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer” NCT00667199 ↗21“Radium-223 dichloride (Xofigo, BAY88-8223) Dose group 1” NCT00337155 ↗ “Radium-223 chloride (Xofigo®, BAY88-8223) injection” NCT00667537 ↗ “Radium Ra 223 dichloride (Xofigo, BAY88-8223)” NCT02442063 ↗ “Radium-223 dichloride (Xofigo, BAY 88-8223)” NCT03996473 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01934790 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT04521361 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT00699751 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT00459654 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01106352 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02605356 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02043678 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01810770 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02258451 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02928029 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02023697 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01565746 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01929655 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02258464 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT04597125 ↗ |
| Modality | Other / unclassified | “investigational radioisotope Radium-223, Alpharadin” NCT00337155 ↗ |
| Route | Other | “given as injection” NCT00337155 ↗ |