NDAINTRAVENOUSSOLUTIONPriority Review
Approved
May 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 13h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XOFIGO is a radioactive alpha-emitting agent (radium Ra-223 dichloride) approved for castration-resistant prostate cancer with bone metastases. It delivers targeted radiation directly to bone lesions, providing symptom relief and survival benefit. This small-molecule radiopharmaceutical represents a unique mechanism in oncology, combining the targeting specificity of a bone-seeking agent with alpha-particle cytotoxicity.
Peak
XOFIGO is at peak commercial maturity with established market penetration in CRPC; brand team likely focused on defending market share against emerging competitors rather than aggressive expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
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)
Started Nov 2020
654 enrolled
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)
Started Aug 2020
1,180 enrolled
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).
Started Mar 2019
346 enrolled
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Multi-academic Center Study of Xofigo Patients
Started Dec 2018
150 enrolled
Prostate Cancer, Castration Resistant
Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
Started Jul 2016
334 enrolled
Prostatic Neoplasms, Castration-Resistant
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.