Drugs / Radium-223 dichloride
Radium-223 dichloride
also known as
BAY88-8223 · Xofigo · Radium Ra 223 dichloride · Alpharadin · Radium-223 chloride · Radium-223 · ²²³Ra-Dichloride · 223Ra-chloride · +3 more
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 35
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT03996473 | Mar 2020 → Apr 2021 | non-small cell lung carcinoma | Bayer | Terminated | No outcome recorded Stop: Enrollment |
| 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 | 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 1/25 trials | ||||||
| Phase 1/2 | NCT02928029 | Feb 2017 → Mar 2019 | plasma cell myeloma | Bayer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02605356 | Oct 2016 → Nov 2019 | plasma cell myeloma | Bayer | Withdrawn | No outcome recorded |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 | NCT01106352 | Jul 2010 → Jun 2015 | castration-resistant prostate carcinoma, metastatic carcinoma in the bone | Bayer | Completed | No outcome recorded |
| Phase 218 trials · 3 met primary · 3 missed | ||||||
| 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 | NCT02903160 | Jan 2017 → Nov 2021 | prostate cancer | Icahn School of Medicine at Mount Sinai | 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 Stop: Business |
| 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 | Missed primary |
| 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 | Missed primary Stop: Enrollment |
| Phase 2 | NCT02484339 | Dec 2014 → Dec 2016 | prostate carcinoma | University Hospital Freiburg | Unknown | No outcome recorded |
| Phase 2 | NCT02199197 | Jun 2014 → Apr 2018 | prostate cancer | University of Utah | Completed | Met primary |
| Phase 2 | NCT02023697 | Mar 2014 → Mar 2017 | prostate cancer | Bayer | Completed | Missed primary |
| 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 | Met primary |
| Phase 2 | NCT00667199 | May 2005 → Apr 2008 | hormone-resistant prostate carcinoma, metastatic carcinoma in the bone | Bayer | Completed | Met primary |
| Phase 2 | NCT00459654 | Feb 2004 → May 2006 | metastatic neoplasm, prostate cancer | Bayer | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT02043678 | Mar 2014 → Feb 2018 | prostate neoplasm | Bayer | Completed | Missed primary |
| 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 | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04597125 | Nov 2020 → Nov 2025 overdue | prostate carcinoma | Bayer | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01516762 | — | prostate neoplasm | Bayer | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT03903835 Comparator | Feb 2019 → Dec 2026 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Karolinska Institutet | Recruiting | Met primary |
| Phase 3 | NCT03458559 Comparator | May 2018 → May 2022 | metastatic prostate carcinoma | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-02-26 | Bayer | Results Bayer’s radium-223 dichloride plus enzalutamide demonstrates significant overall survival benefit in the PEACE-3 trial in patients with metastatic castration-resistant prostate cancer with bone metastases bayer.com ↗
Final overall survival (OS) results from the PEACE-3 trial show enzalutamide in combination with radium-223 dichloride reduces the risk of death by 24% versus enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases |
| 2024-04-03 | Bayer | Results Bayer and Vividion Therapeutics to highlight advancing oncology portfolio at AACR 2024 Annual Meeting bayer.com ↗
Another abstract will highlight the synergistic anti-cancer effects of targeted alpha therapy radium-223 dichloride (Xofigo™) in combination with darolutamide in preclinical prostate cancer models. |
| 2024-04-03 | Vividion Therapeutics, Inc. | Results Bayer and Vividion Therapeutics to highlight advancing oncology portfolio at AACR 2024 Annual Meeting vividion.com ↗
Another abstract will highlight the synergistic anti-cancer effects of targeted alpha therapy radium-223 dichloride (Xofigo™) in combination with darolutamide in preclinical prostate cancer models. |
| 2023-04-11 | Bayer | Results Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting bayer.com ↗
Radium-223 demonstrates increased antitumor activity in combination with 177Lu-PSMA-617 in the intratibial LNCaP xenograft model of bone metastatic prostate cancer |
| 2021-04-06 | Bayer | Results Bayer to present new clinical data in indolent non-Hodgkin’s Lymphoma and additional research on its oncology portfolio at AACR Annual Meeting 2021 bayer.com ↗
In addition, preclinical data on the synergistic antitumor effect of radium-223 dichloride and enzalutamide will be presented. |
| 2021-02-08 | Bayer | Results New data presented at 2021 ASCO GU Cancers Symposium add to robustness of the overall survival benefit and favorable safety profile for Nubeqa™ bayer.com ↗
Radium-223 + enzalutamide resulted in significant long-term clinical benefit when compared to enzalutamide alone in mCRPC patients, without compromising safety. |
| 2020-08-27 | Bayer | Regulatory Bayer receives approval for Xofigo® in China bayer.com ↗
The Chinese National Medical Products Administration (NMPA) has approved Xofigo® (radium-223 dichloride) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. |
| 2017-11-30 | Bayer | Results Phase III trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone for patients with metastatic castration-resistant prostate cancer unblinded early bayer.com ↗
Bayer today announced that an Independent Data Monitoring Committee (IDMC) has recommended to unblind a Phase III trial of radium-223 dichloride (radium-223) in combination with abiraterone acetate and prednisone/prednisolone in prostate cancer. |
All press releases naming this drug 8 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Radium 223 dichloride | “Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections” NCT02582749 ↗26“Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01106352 ↗ |
| 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 | 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 201623“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)” NCT01106352 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02605356 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT00699751 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02023697 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01929655 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02258464 ↗ |
| 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 | 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 2013 |
| Known as | Radium-223 | “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01565746 ↗2“Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01934790 ↗ “Radium-223 dichloride (BAY88-8223)” NCT01618370 ↗ |
| Known as | Radium-223 chloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03458559 ↗ |
| Known as | Xofigo | “Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer” NCT00667199 ↗20“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)” NCT01929655 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT00699751 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT01810770 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02023697 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT02605356 ↗ “Radium-223 dichloride (Xofigo, BAY88-8223)” NCT04597125 ↗ |
| Known as | ²²³Ra | “²²³Ra-Dichloride (²²³Ra) is a novel bone-seeking alpha-emitter” PMID 23653243 ↗ May 2013 |
| 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 |
| Modality | Other / unclassified | “investigational radioisotope Radium-223, Alpharadin” NCT00337155 ↗ |
| Route | Other | “given as injection” NCT00337155 ↗ |