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Xofigo (RADIUM RA 223 DICHLORIDE)
Xofigo works by emitting alpha particles that selectively target and kill cancer cells in the prostate.
Xofigo (Radium Ra 223 Dichloride) is a small molecule drug developed by Bayer Healthcare, currently owned by the same company. It is a radionuclide therapy used to treat malignant tumors of the prostate. Xofigo was FDA-approved in 2013 and is still a patented product. It is administered intravenously and has a targeted mechanism of action. Key safety considerations include myelosuppression and renal toxicity.
At a glance
| Generic name | RADIUM RA 223 DICHLORIDE |
|---|---|
| Sponsor | Bayer |
| Drug class | radium Ra 223 dichloride |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2013 |
| Annual revenue | 400 |
Mechanism of action
The active moiety of Xofigo is the alpha particle-emitting isotope radium-223 (as radium Ra 223 dichloride), which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases (see Table 2). The high linear energy transfer of alpha particles (80 keV/micrometer) leads to high frequency of double-strand DNA breaks in adjacent cells including tumor cells, osteoblasts and osteoclasts, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers (less than 10 cell diameters) which limits damage to the surrounding normal tissue.
Approved indications
- Malignant tumor of prostate
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Peripheral edema
- Anemia
- Lymphocytopenia
- Leukopenia
- Thrombocytopenia
- Neutropenia
- Pancytopenia
- Renal failure and impairment
- Dehydration
Key clinical trials
- Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones (PHASE2)
- Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy (PHASE1,PHASE2)
- Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study (PHASE2)
- Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer (PHASE1)
- RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer) (PHASE4)
- Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer (PHASE2)
- A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases (PHASE3)
- Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis (PHASE1,PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xofigo CI brief — competitive landscape report
- Xofigo updates RSS · CI watch RSS
- Bayer portfolio CI