CLINICAL TRIALS PROFILE FOR XOFIGO

All Clinical Trials for Xofigo

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00667199 ↗	BAY88-8223, Does Response Study in HRPC Patients	Completed	Bayer	Phase 2	2005-05-30	The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
NCT00667537 ↗	PK in Pts With HRPC & Skeletal Metastes	Completed	Bayer	Phase 1	2007-07-01	Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart). Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection
NCT00748046 ↗	Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton	Completed	Bayer	Phase 1	2008-08-01	The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).
NCT01070485 ↗	BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant Disease	Completed	Bayer	Phase 2	2010-01-01	The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed.
NCT02097303 ↗	Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis	Completed	Bayer	Phase 2	2014-03-01	This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.
NCT02097303 ↗	Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis	Completed	Carolina Research Professionals, LLC	Phase 2	2014-03-01	This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.

Clinical Trial Conditions for Xofigo

Condition Name

Condition Name for Xofigo
Intervention	Trials
Prostate Cancer	8
Prostatic Neoplasms, Castration-Resistant	3
Castration-Resistant Prostate Carcinoma	3
Bone Metastases	3

Condition MeSH

Condition MeSH for Xofigo
Intervention	Trials
Prostatic Neoplasms	24
Neoplasm Metastasis	9
Bone Neoplasms	5
Bone Marrow Diseases	5

Clinical Trial Locations for Xofigo

Trials by Country

Trials by Country for Xofigo
Location	Trials
United States	82
Italy	11
Germany	6
United Kingdom	6
Spain	5

Trials by US State

Trials by US State for Xofigo
Location	Trials
California	8
Pennsylvania	6
Michigan	5
Massachusetts	4
New York	4

Clinical Trial Progress for Xofigo

Clinical Trial Phase

Clinical Trial Phase for Xofigo
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	14

Clinical Trial Status

Clinical Trial Status for Xofigo
Clinical Trial Phase	Trials
Completed	13
Recruiting	8
Active, not recruiting	7

Clinical Trial Sponsors for Xofigo

Sponsor Name

Sponsor Name for Xofigo
Sponsor	Trials
Bayer	18
National Cancer Institute (NCI)	5
M.D. Anderson Cancer Center	2

Sponsor Type

Sponsor Type for Xofigo
Sponsor	Trials
Industry	22
Other	22
NIH	5

Xofigo (radium Ra 223 dichloride) Clinical Trials Update and Market Outlook

Last updated: April 26, 2026

What is Xofigo and what is its current clinical position?

Xofigo is radium Ra 223 dichloride (alpha-emitting radiopharmaceutical) approved for men with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease. The clinical core is the phase 3 ALSYMPCA trial, which established an overall survival (OS) benefit on top of standard of care.

Key efficacy and survival benchmark (ALSYMPCA)

Endpoint (ALSYMPCA)	Result	Clinical meaning
Overall survival (OS)	Median 14.9 vs 11.3 months	Improved survival versus placebo plus best standard of care
OS hazard ratio	0.70	30% relative reduction in risk of death
p-value	<0.001	Statistically significant OS benefit
Time to first symptomatic skeletal event	Improved	Reduced progression of skeletal symptoms (per trial design)

(Trial benchmark is widely cited for regulatory and commercialization history.) [1]

Practice-defining safety signals

Safety issue	Pattern in Ra-223 clinical use	Action in labeling/practice
Myelosuppression (thrombocytopenia, neutropenia)	Frequency increased with prior systemic therapy exposure	Monitoring and dose delay/modification guidance
GI toxicity	Nausea, vomiting, diarrhea reported	Supportive care and monitoring
Bone marrow reserve constraints	Patients with low baseline counts at higher risk	Baseline hematologic checks and treatment hold thresholds

(These safety themes align with the established Ra-223 risk profile used in label and clinical management.) [1]

What is the latest clinical-trials activity for Xofigo?

No “latest” trial updates can be stated from the information provided in this prompt. A complete, accurate trials update requires a live registry pull (e.g., ClinicalTrials.gov) with filters for radium Ra 223, recruitment status changes, and publication dates. Under the constraints here, a definitive “latest” update cannot be produced without that source data.

What does the market look like for Xofigo today?

Xofigo’s addressable market has tightened over time due to changes in the CRPC treatment landscape, including earlier and broader uptake of:

• Androgen receptor pathway inhibitors (e.g., abiraterone/enzalutamide)
• Taxane chemotherapy sequencing
• PARP inhibitors for biomarker-selected patients
• Evolving use of radioligand therapy such as PSMA-targeted agents in metastatic settings

Xofigo’s label confines use to symptomatic bone-predominant disease without known visceral metastases, and that niche has faced competition from therapies that can treat broader metastatic compartments or that are used earlier in disease trajectories. The commercial outcome for Ra-223 has historically tracked with these sequencing shifts and with payer coverage limitations tied to line of therapy, performance status, and baseline marrow reserve.

Commercial drivers that historically support or restrict uptake

Driver	Effect on demand	Why it matters
Label population narrowness	Downward pressure	Many CRPC patients progress with visceral involvement or start other systemic agents earlier
Hematologic eligibility	Restriction	Requires adequate marrow reserve, limiting eligibility in heavily pre-treated populations
Treatment sequencing	Volatility	Uptake depends on how clinicians sequence ARPI, taxanes, and other radiopharmaceuticals
Competition from newer radioligands	Downward pressure	PSMA-directed therapies expand radiopharmaceutical choice in mCRPC

What is the market projection for Xofigo?

A numeric projection requires current revenue/market-size baselines and a time-series view of prescriptions, geography, pricing, and payer policy changes. The prompt provides none of these required inputs, so a complete and accurate projection cannot be stated under the operating constraints.

How do clinical outcomes translate to commercial positioning?

Xofigo’s clinical story is anchored in survival improvement in ALSYMPCA for a defined bone-metastatic niche. That benefit supports its use in guideline-aligned settings where the intent is to extend survival while targeting bone metastases and avoiding visceral disease inclusion.

Positioning map (clinical intent to use-case)

Clinical intent	Best-fit patient profile	Xofigo role
Survival extension	Symptomatic bone metastases, no known visceral metastases, CRPC	Core use per ALSYMPCA outcomes
Skeletal symptom control	Bone-predominant symptomatic disease	Reduced skeletal events in trial data
Avoid visceral irradiation exposure	Patients without visceral metastatic disease	Label-constrained mechanism-fit

What is the IP and exclusivity context that shapes long-run economics?

A full IP-exclusivity analysis requires jurisdiction-by-jurisdiction filings and expiry dates for composition-of-matter and method-of-use claims, plus any supplementary protection certificates or patent term adjustments. The prompt provides no such patent dataset, so a complete and accurate IP and exclusivity impact cannot be produced.

Key Takeaways

• Xofigo’s clinical foundation is phase 3 ALSYMPCA, which demonstrated OS improvement versus placebo plus best standard of care (median 14.9 vs 11.3 months; HR 0.70, p < 0.001). [1]
• Uptake is structurally constrained by the label: symptomatic bone metastases with no known visceral metastatic disease, plus eligibility limits related to myelosuppression risk and hematologic reserve. [1]
• A “latest clinical trials update” and a numeric market projection require live, source-backed inputs (trial registry status changes and current commercial baselines). Those cannot be produced from the information in the prompt.

FAQs

1. What patient population is Xofigo indicated for?
   Men with CRPC with symptomatic bone metastases and no known visceral metastatic disease. [1]

2. What trial established Xofigo’s survival benefit?
   The phase 3 ALSYMPCA trial. [1]

3. What is the magnitude of Xofigo’s overall survival benefit?
   Median OS 14.9 months vs 11.3 months (HR 0.70, p <0.001). [1]

4. What are the principal safety considerations?
   Myelosuppression (notably thrombocytopenia and neutropenia) drives monitoring and treatment delays. [1]

5. Why has Xofigo faced commercial pressure over time?
   The CRPC treatment landscape has expanded to earlier systemic lines and broader metastatic targeting, narrowing the bone-only, no-visceral niche. (Clinical practice shift consistent with label constraints.) [1]

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References (APA)

[1] Bayer. (n.d.). Xofigo (radium Ra 223 dichloride) prescribing information.