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radium-223

Trade name: xofigo

Small moleculeapprovedFast Track FDA

Approved

May 15, 2013

Radium Ra 223 dichloride is a radiotherapeutic drug that is approved for the treatment of male patients with symptoms of advanced prostate cancer with bone metastases. Ra 223 mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover. The radioactive alpha particles emitted by radium Ra 223 helps in killing cancer cells in the bone by damaging their DNA. Radium Ra 223 causes minimal damage to the nearby healthy cells. — NCATS

Clinical trial activity

68 trials · 57 clinical orgs · 2 marketing orgs

Phase 1
21
Phase 2
51
Phase 3
11
Phase 4
2

Earliest trial started Aug 14, 2001 (NCT01798108)

Timeline

2000s

  1. Jan 1, 2001

    Bayer — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Bayer — Earliest Phase 2 Sponsor(trial)

  3. Mar 1, 2006

    Algeta ASA — IND Organization

  4. Mar 1, 2006

    Algeta ASA — IND Organization

  5. Jan 1, 2008

    Bayer — Earliest Phase 3 Sponsor(trial)

2010s

  1. May 15, 2013

    Bayer — Earliest FDA Approval

  2. May 15, 2013

    Bayer — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Radiotherapy agent

    Radiotherapy agent, binds to hydroxyapatite in bone, where alpha radiation results in double strand DNA breaks.

  • Unspecified targetRadiodepletion

    Radiodepletion

    Radiotherapy agent, binds to hydroxyapatite in bone, where alpha radiation results in double strand DNA breaks.

Approval history

  • approvedPriority reviewFast trackMay 15, 2013

Chemistry & pharmacology

Loading structure…

SMILES

Cl[Ra]Cl
Mol. weight
296.91 g/mol
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • alpharadin
  • bay 88-8223
  • ra223
  • ra 223 dichloride
  • radium
  • radium
  • radium-223
  • radium-223
  • radium-223
  • radium-223 chloride
  • radium-223 dichloride
  • radium-223 dichloride
  • radium-223 dichloride
  • radium (223ra) dichloride
  • radium (223ra) dichloride
  • radium chloride ra 223
  • radium chloride ra-223
  • radium chloride ra-223
  • radium chloride ra-223
  • radium dichloride
  • radium ra-223
  • radium ra-223
  • radium ra 223 dichloride
  • radium ra 223 dichloride
  • radium ra 223 dichloride
  • radium ra 223 dichloride
  • radium ra 223 dichloride
  • radium ra 223 dichloride
  • radium ra-223 dichloride
  • radium ra-223 dichloride
  • radium ra-223 dichloride
  • radium ra223 dichloride
  • xofigo
  • xofigo
  • xofigo
  • xofigo

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05924672Phase 2Dec 18, 2023Bayer, University of California, San Francisco
NCT05771896Phase 3Sep 30, 2023Bayer, Fundacion GenesisCare
NCT05383079Phase 1/Phase 2 (Phase 2)Sep 13, 2022Peter MacCallum Cancer Centre
NCT05133440Phase 2Nov 12, 2021Memorial Sloan-Kettering Cancer Center
NCT04521361Phase 1Nov 16, 2020Bayer
NCT04597125Phase 4Nov 9, 2020Bayer
NCT04237584Phase 3May 31, 2020Bayer, Carolina Urologic Research Center, MANA RBM, Tulane University, Wayne State University
NCT04206319Phase 2Dec 25, 2019National Cancer Institute (NCI)
NCT03996473Phase 1/Phase 2 (Phase 2)Oct 3, 2019Bayer
NCT04037358Phase 2Aug 31, 2019Johns Hopkins University
NCT03753776Phase 3Jun 1, 2019Institut de Cancérologie de la Loire (ICLN), Institut de Cancérologie Lucien Neuwirth
NCT03903835Phase 3Feb 1, 2019Karolinska Institute, The Swedish Research Council
NCT03574571Phase 3Jun 19, 2018Bayer, Memorial Sloan-Kettering Cancer Center
NCT03458559Phase 3May 16, 2018Free University of Amsterdam
NCT03432949Phase 4Feb 23, 2018Bayer, University of Toronto
NCT03304418Phase 2Feb 12, 2018Bayer, University of Utah
NCT03208712Early Phase 1 (Phase 1)Nov 1, 2017University of Michigan
NCT03305224Phase 2Oct 27, 2017Bayer, Osaka City University
NCT03230734Phase 2Sep 1, 2017Istituto Nazionale per lo Studio e la Cura dei Tumori
NCT03062254Phase 2Aug 1, 2017McGill University
Showing 20 of 68 trials
Page 1 / 4

Organizations

Research & Development (57)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit462652001
Johns Hopkins UniversityAcademic/Hospital3322015
University of Texas at HoustonAcademic/Hospital3322013
AstellasFor profit2022015
Cancer Trials IrelandAcademic/Hospital2122015
Carolina Research Professionals, LLCFor profit2212014
Cornell UniversityAcademic/Hospital2122008
Harvard UniversityAcademic/Hospital2222015
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2222018
University of UtahAcademic/Hospital2212014
Academic and Community Cancer Research UnitedAcademic/Hospital1012015
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie (ARTIC)Academic/Hospital1112016
Brown UniversityAcademic/Hospital1112015
Canadian Urology Research ConsortiumAcademic/Hospital1112015
Cantonal Hospital of St. GallenAcademic/Hospital1012015
Carolina Urologic Research CenterFor profit1012020
Duke UniversityAcademic/Hospital1112014
European Organisation for Research and Treatment of CancerAcademic/Hospital1112015
Free University of AmsterdamAcademic/Hospital1112018
Fundacion GenesisCareAcademic/Hospital1112023
57 organizations
Page 1 / 3

Marketing (3)

OrganizationOrg typeRelationshipDate
Algeta ASAFor profitINDMar 1, 2006
BayerFor profitSYNMay 15, 2013
BayerFor profitNDAMay 15, 2013