CLINICAL TRIALS PROFILE FOR IOBENGUANE SULFATE I-123

All Clinical Trials for IOBENGUANE SULFATE I-123

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01175356 ↗	Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin	Active, not recruiting	National Cancer Institute (NCI)	N/A	2010-10-01	This clinical trial is studying induction therapy followed by meta-iodobenzylguanidine (MIBG) labeled with iodine-131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as MIBG labeled with iodine-131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as cisplatin, etoposide, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant can replace blood-forming cells that are damaged by MIBG labeled with iodine-131 and chemotherapy.
NCT01175356 ↗	Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin	Active, not recruiting	Children's Oncology Group	N/A	2010-10-01	This clinical trial is studying induction therapy followed by meta-iodobenzylguanidine (MIBG) labeled with iodine-131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as MIBG labeled with iodine-131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as cisplatin, etoposide, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant can replace blood-forming cells that are damaged by MIBG labeled with iodine-131 and chemotherapy.
NCT02035137 ↗	131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinistat	Active, not recruiting	New Approaches to Neuroblastoma Therapy Consortium	Phase 2	2014-07-01	This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.

Clinical Trial Conditions for IOBENGUANE SULFATE I-123

Condition Name

Condition Name for IOBENGUANE SULFATE I-123
Intervention	Trials
Neuroblastoma	3
Ganglioneuroblastoma	2
Recurrent Neuroblastoma	1

Condition MeSH

Condition MeSH for IOBENGUANE SULFATE I-123
Intervention	Trials
Neuroblastoma	4
Ganglioneuroblastoma	2

Clinical Trial Locations for IOBENGUANE SULFATE I-123

Trials by Country

Trials by Country for IOBENGUANE SULFATE I-123
Location	Trials
United States	87
Canada	6
Puerto Rico	1

Trials by US State

Trials by US State for IOBENGUANE SULFATE I-123
Location	Trials
Washington	4
Texas	4
Pennsylvania	4
Ohio	4
North Carolina	4

Clinical Trial Progress for IOBENGUANE SULFATE I-123

Clinical Trial Phase

Clinical Trial Phase for IOBENGUANE SULFATE I-123
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for IOBENGUANE SULFATE I-123
Clinical Trial Phase	Trials
Recruiting	2
Active, not recruiting	2

Clinical Trial Sponsors for IOBENGUANE SULFATE I-123

Sponsor Name

Sponsor Name for IOBENGUANE SULFATE I-123
Sponsor	Trials
National Cancer Institute (NCI)	2
Children's Oncology Group	2
New Approaches to Neuroblastoma Therapy Consortium	2

Sponsor Type

Sponsor Type for IOBENGUANE SULFATE I-123
Sponsor	Trials
Other	4
NIH	2
Industry	1

Iobenguane Sulfate I-123 (I-123 MIBG): Clinical Trial Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is the current clinical trial status for iobenguane sulfate I-123?

Public, current, and complete trial-status reporting for iobenguane sulfate I-123 is not available from the provided information.

What is the commercial landscape for iobenguane sulfate I-123 (MIBG I-123)?

Core indication geography and demand driver

Iobenguane sulfate I-123 (MIBG I-123) is used for evaluation of neuroendocrine tumors (notably neuroblastoma in pediatric populations and related use cases) and for imaging-driven management decisions in select settings. Demand is driven by:

• Incidence and treatment pathways in pediatric neuroblastoma and related neuroendocrine tumor workflows
• Availability of radiopharmacy capacity and patient throughput in nuclear medicine sites
• Imaging adoption in care pathways where MIBG is integrated into staging, response assessment, and risk stratification

Competitive and alternative modality pressure

The competitive set is best characterized by imaging alternatives and workflow substitutes rather than direct pharmacologic competitors. Key pressures include:

• Cross-modality imaging that may reduce reliance on MIBG in certain decision trees
• Site-level protocol variability (hospital-specific adoption of MIBG vs alternatives)
• Radiopharmaceutical supply chain constraints that can limit scheduled imaging capacity and impact repeat dosing utilization

Pricing and reimbursement mechanics (market structure)

iobenguane sulfate I-123 is typically commercialized within radiopharmaceutical reimbursement structures that depend on:

• Per-dose reimbursement and imaging bundle coding at the provider level
• Center-specific contracting with payers for nuclear medicine services
• Throughput and scan scheduling efficiency at radiopharmacy and imaging centers

What is the market projection path for iobenguane sulfate I-123?

A complete market model requires launch-level commercialization specifics (current net pricing, payer rates, utilization by indication, and supply constraints) and up-to-date trial timelines for incremental label expansion. Those inputs are not present in the provided information, so a complete and accurate projection cannot be produced.

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Key Takeaways

• No complete, reliable clinical trial update can be produced from the provided information.
• Market characterization can be stated at a high level (imaging-driven demand, workflow and capacity constraints, and modality competition), but a quantified market projection cannot be produced without utilization, pricing, reimbursement, and timeline inputs.
• For business decisions, the most material variables are radiopharmacy capacity and imaging protocol adoption at nuclear medicine sites.

FAQs

1. Is iobenguane sulfate I-123 a therapy or an imaging agent?
   It is used as a radiopharmaceutical for imaging in neuroendocrine tumor care pathways.

2. What primarily drives demand?
   Patient volume in relevant indications and the extent to which MIBG is integrated into staging and response assessment protocols at treating centers.

3. What are the main market constraints?
   Radiopharmacy and isotope supply chain capacity, plus center scheduling and throughput limitations.

4. How does competition typically show up?
   Through imaging-alternative modalities and protocol decisions that shift use away from MIBG in specific pathways.

5. Can a numerical market forecast be built from limited inputs?
   Not reliably. A credible projection requires dose utilization, pricing/reimbursement, and label or trial-driven demand expansion timelines.

References

[1] None.