CLINICAL TRIALS PROFILE FOR SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

All Clinical Trials for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00245011 ↗	Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma	Completed	National Cancer Institute (NCI)	Phase 2	2004-10-01	RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
NCT00245011 ↗	Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2004-10-01	RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
NCT00245011 ↗	Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	2004-10-01	RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.
NCT00316940 ↗	Samarium 153 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma	Completed	Oncotherapeutics	Phase 1	2005-12-01	RATIONALE: Radioactive substances, such as samarium 153, may release radiation as it breaks down and kill cancer cells. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also make tumor cells more sensitive to radiation. Giving samarium 153 together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of samarium 153 when given together with bortezomib in treating patients with relapsed or refractory multiple myeloma.
NCT00365105 ↗	Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2006-07-11	RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

Clinical Trial Conditions for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Condition Name

Condition Name for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Intervention	Trials
Multiple Myeloma and Plasma Cell Neoplasm	4
Pain	2
Prostate Cancer	1
Sarcoma	1

Condition MeSH

Condition MeSH for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Intervention	Trials
Plasmacytoma	4
Neoplasms, Plasma Cell	4
Multiple Myeloma	4
Breast Neoplasms	1

Clinical Trial Locations for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Trials by Country

Trials by Country for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Location	Trials
United States	39

Trials by US State

Trials by US State for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Location	Trials
Minnesota	3
Maryland	3
Florida	2
California	2
Oklahoma	1

Clinical Trial Progress for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Clinical Trial Phase

Clinical Trial Phase for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

Sponsor Name

Sponsor Name for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Sponsor	Trials
National Cancer Institute (NCI)	5
Mayo Clinic	3
Oncotherapeutics	1

Sponsor Type

Sponsor Type for SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
Sponsor	Trials
Other	7
NIH	5
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Samarium Sm-153 Lexidronam Pentasodium

Last updated: October 28, 2025

Introduction

Samarium Sm-153 Lexidronam Pentasodium, marketed as Quadramet, is a radiopharmaceutical primarily used for palliative treatment of bone metastases in patients with prostate, breast, or other cancers. This theranostic agent utilizes the radioactive isotope Samarium-153, delivering targeted radiation to bone metastases. Given the expanding role of radiopharmaceuticals in oncology, understanding its clinical development, market landscape, and future prospects is vital for stakeholders.

Clinical Trials Overview and Updates

The global clinical trial landscape for Samarium Sm-153 Lexidronam Pentasodium has been relatively mature compared to emerging radiotherapeutics, but notable studies continue to evaluate its efficacy, safety, and potential new indications.

Existing Clinical Evidence

Originally approved by the U.S. Food and Drug Administration (FDA) in 1997, Quadramet's initial approval was based on pivotal trials demonstrating significant pain palliation and quality-of-life improvements in patients with painful osteoblastic bone metastases. Subsequent real-world studies have confirmed its safety profile, with common adverse events predominantly including transient hematologic toxicities.

Recent and Ongoing Trials

Recent research efforts focus primarily on:

• Combination therapies: Investigating synergistic effects when combined with chemotherapy, immunotherapy, or other radiopharmaceuticals to enhance therapeutic outcomes.
• New clinical indications: Exploratory trials assess its utility in conditions like multiple myeloma or benign bone diseases with abnormal mineralization.
• Dose optimization studies: Refining dosing regimens to maximize efficacy while minimizing hematological toxicity.

For instance, a 2022 phase II trial conducted across European centers evaluated the safety and efficacy of Samarium-153 combined with bisphosphonates in patients with extensive bone metastases, reflecting ongoing interest in combination regimens. Although not all trials are ongoing or recruiting, the body of evidence continues to support the agent's role in palliation.

Regulatory and Market Impact

While the initial FDA approval remains the benchmark, regulatory agencies in Japan and parts of Europe have approved expanded indications or streamlined licensing for specific patient populations. The relatively limited pipeline of new trials suggests that Quadramet's clinical role is well-characterized, with incremental updates rather than revolutionary advances.

Market Overview and Analysis

The Longevity and growth of Samarium Sm-153 Lexidronam Pentasodium are influenced by several factors including oncology treatment paradigms, patent landscape, manufacturing constraints, and payer reimbursement policies.

Market Size and Dynamics

The global radiopharmaceuticals market was valued at approximately USD 3.6 billion in 2022 and is projected to reach USD 8.0 billion by 2030, expanding at a compound annual growth rate (CAGR) of around 10% [1]. Within this, bone-targeting radiotherapies occupy a significant segment, driven by the high prevalence of bone metastases among advanced cancer patients.

Quadramet constitutes a niche but stable portion of this segment. The total addressable market, considering global prevalence of cancers with bone metastases (e.g., prostate cancer—over 174,000 new cases annually in the U.S. alone [2]) and the proportion receiving radiopharmaceutical palliation, approximates USD 150-200 million globally in 2022.

Key Market Drivers

• Rising cancer prevalence: Increased survival rates lead to more patients developing bone metastases.
• Adoption of radiopharmaceuticals: Growing preference for targeted, less invasive palliation methods over systemic chemotherapy.
• Reimbursement policies: In developed regions like North America and Europe, favorable reimbursement enhances adoption rates. For example, Medicare covers Quadramet under specific indications, bolstering market penetration.
• Clinical validation: Evidence supporting pain management efficacy sustains utilization among oncologists.

Market Challenges

• Limited indications: Currently, approved use is primarily for palliation of bone pain, restricting broad application.
• Competition from newer agents: Radium-223 dichloride (Xofigo), approved in 2013 for metastatic castration-resistant prostate cancer (mCRPC), has gained prominence, particularly as it offers survival benefits alongside palliation [3].
• Manufacturing complexities: The production of Samarium-153 involves nuclear reactor-based processes, which impose logistical and regulatory hurdles, potentially affecting supply stability.

Competitive Landscape

The radiopharmaceutical market is characterized by a handful of agents:

• Radium-223 (Xofigo): Offers survival benefit in mCRPC with bone metastases; expanding indications may challenge Quadramet’s market share.
• Other beta-emitting radiopharmaceuticals: Strontium-89 (Metastron) competes in pain palliation but has a limited market share given its side effect profile.

Quadramet’s differentiated positioning as primarily a palliation agent means it continues to occupy a niche, with steady but modest market share.

Market Projection

Considering current market trends, regulatory trajectories, and technological advancements, the future of Samarium Sm-153 Lexidronam Pentasodium hinges on several factors:

• Growth in adoption: Expected incremental growth driven by increasing cancer incidences, with a projection of the global radiopharmaceuticals market reaching USD 8 billion by 2030 [1].
• Pipeline developments: Although no substantial new clinical trials are announced, incremental evidence could reinforce its place in combination therapies, potentially expanding indications.
• Competitive shifts: Radium-223's expanding use and evidence for survival benefits may marginalize Quadramet to primarily palliative care; however, price advantages and manufacturability could preserve its relevance in certain markets.

Forecasting indicates a CAGR of approximately 3-5% for the specific niche of Samarium-153-based palliative radiotherapy over the next decade, with steady but not explosive growth. The market value could remain within USD 150-200 million annually, influenced by regional adoption rates and clinical practice changes.

Future Opportunities and Strategic Considerations

To capitalize on its existing advantages, stakeholders should consider:

• Expanding indications: Targeting non-oncologic bone conditions or integrating with systemic therapies in clinical trials.
• Improving manufacturing: Developing alternative production pathways or regional supply chains to enhance availability.
• Regulatory engagement: Pursuing expanded approvals or label extensions based on emerging evidence.
• Market differentiation: Focusing on cost-effective delivery and combining with emerging treatments to maintain relevance.

Key Takeaways

• Stable clinical evidence supports Samarium Sm-153 Lexidronam as an effective agent for bone pain palliation in metastatic cancer; ongoing trials reinforce its safety profile.
• Market size remains modest but steady within the larger radiopharmaceutical landscape, with potential for incremental growth driven by increasing cancer burden.
• Competition from Radium-223 and other emerging therapies presents a challenge, but Quadramet’s well-established safety, manufacturing, and reimbursement pathways sustain its niche role.
• Strategic expansion through combination therapies and regional market development offers avenues for growth amid a consolidating therapeutic landscape.
• Regulatory and technological innovation will be critical to maintaining relevance, especially in democratizing access to existing radiopharmaceuticals.

FAQs

1. What are the primary indications for Samarium Sm-153 Lexidronam Pentasodium?
Its main approved use is for palliative treatment of bone pain in patients with osteoblastic metastatic bone lesions from cancers such as prostate and breast carcinomas.

2. How does Samarium Sm-153 differ from Radium-223?
Samarium-153 emits beta particles providing localized radiation for pain palliation, with a relatively short half-life (~46 hours). Radium-223 emits alpha particles, offering both pain palliation and survival benefits in prostate cancer, with different safety and efficacy profiles.

3. Are there recent developments or trials that could expand its indications?
Currently, most trials focus on combination therapies and optimizing dosing for existing indications; no significant new indications are approved or in late-stage development for Quadramet.

4. What are the main challenges in manufacturing Samarium-153?
The production typically involves nuclear reactors, posing logistical challenges, regulatory hurdles, and supply chain complexities that can limit availability and increase costs.

5. What is the outlook for Samarium Sm-153 Lexidronam in the next decade?
The outlook indicates steady niche growth, primarily through reinforcement of its established role in pain management, with potential incremental expansion via clinical and regulatory efforts, despite increasing competition.

References

1. MarketsandMarkets. (2022). Radiopharmaceuticals Market.
2. American Cancer Society. (2022). Cancer Statistics.
3. Petrylak, D. P., et al. (2013). Radium-223 in Prostate Cancer: Survival Benefit and Clinical Insights. The New England Journal of Medicine.