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DRUG:

Azedra (iobenguane I 131)

i
Other names: 131I-MIBG, I-131 MIBG, MIP-120T, Ultratrace MIBG , MIBG-I131
Associations
Company:
Lantheus
Drug class:
Beta radiation emitter, Norepinephrine reuptake inhibitor
Related drugs:
Associations
28d
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma (clinicaltrials.gov)
P2, N=200, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
Trial completion date • Trial primary completion date
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CD34 (CD34 molecule)
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Azedra (iobenguane I 131)
1m
Pituitary dysfunction in childhood after [177Lu]Lu-DOTATATE therapy. (PubMed, J Pediatr Endocrinol Metab)
We hypothesize that the GH and TSH deficiency in this case are caused by pituitary damage through binding of [ 177 Lu]Lu-DOTATATE to the somatostatin receptors in the pituitary gland. If [ 177 Lu]Lu-DOTATATE in the future becomes a more upfront treatment we strongly underline screening on pituitary dysfunction after exposure to [ 177 Lu]Lu-DOTATATE in childhood.
Journal
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SSTR (Somatostatin Receptor)
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Azedra (iobenguane I 131)
3ms
Trial completion • Trial completion date
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
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MYCN amplification
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cisplatin • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • melphalan • busulfan • Azedra (iobenguane I 131)
4ms
The Current Status of Nuclear Medicine in Africa. (PubMed, J Nucl Med)
177Lu-therapies are restricted to 7 countries, and the availability of [131I]MIBG remains limited...Sustained investment in facilities, training, and regulatory frameworks is essential to achieve equitable access to care. IAEA's regional anchor centers as part of the Rays of Hope initiative exemplifies strategic capacity building, collaboration, and knowledge sharing in the region.
Journal
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SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
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Azedra (iobenguane I 131)
4ms
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab (clinicaltrials.gov)
P2, N=118, Not yet recruiting, New Approaches to Neuroblastoma Therapy Consortium
New P2 trial
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Zolinza (vorinostat) • Unituxin (dinutuximab) • Azedra (iobenguane I 131)
4ms
Update on Systemic Therapies for Metastatic/Unresectable Pheochromocytomas and Paragangliomas and Future Directions. (PubMed, Cancers (Basel))
Radiopharmaceuticals such as 131I-MIBG and 177Lu-DOTATATE continue to play a pivotal role, achieving disease control in many patients. Cytotoxic regimens, particularly temozolomide, remain relevant, with some studies suggesting that SDHB-mutated PPGLs demonstrate a heightened sensitivity associated with MGMT promoter hypermethylation and reduced MGMT expression. Targeted agents are increasingly important: multi-kinase inhibitors such as sunitinib, anlotinib, and cabozantinib have shown meaningful activity. The landmark approval of belzutifan, a HIF-2α inhibitor, in 2025 represents the first oral targeted therapy for advanced/metastatic PPGL, which is particularly relevant for pseudohypoxic Cluster 1 tumors...This review summarizes current evidence and highlights ongoing clinical trials, underscoring a paradigm shift toward precision medicine and rational combination strategies. Collectively, these advances bring cautious optimism that metastatic PPGLs may soon become a more manageable chronic disease with improved survival and quality of life.
Review • Journal • PARP Biomarker • IO biomarker
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MGMT (6-O-methylguanine-DNA methyltransferase) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1)
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Focus V (anlotinib) • sunitinib • temozolomide • Cabometyx (cabozantinib tablet) • Welireg (belzutifan) • Lutathera (lutetium Lu 177 dotatate) • Azedra (iobenguane I 131)
5ms
Experimental study on the treatment of norepinephrine transporter-overexpressing pheochromocytomas and paragangliomas: a synthetic lethality strategy combining 131I-MIBG with PARP inhibitors. (PubMed, Front Oncol)
This study aims to investigate the therapeutic potential of 131I-MIBG and the PARP inhibitor fluzoparib monotherapies and their combination on two distinct PC12-derived stable cell lines: PC12-NET cells and PC12-NET-SDHB cells...The specificity of PC12-NET cells to the 131I-MIBG was confirmed through desipramine inhibition assays...The combined of 131I-MIBG with PARP inhibitor demonstrated a synergistic antitumor effect in PC12-NET cells. While PC12-NET-SDHB cells display comparable sensitivity to 131I-MIBG as PC12-NET cells, they exhibited heightened responsiveness to PARP inhibitor treatment.
Journal • PARP Biomarker
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SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B)
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AiRuiYi (fluzoparib) • Azedra (iobenguane I 131)
5ms
MIBG for Refractory Neuroblastoma and Pheochromocytoma (clinicaltrials.gov)
P=N/A, N=15, Completed, Masonic Cancer Center, University of Minnesota | Suspended --> Completed | N=100 --> 15
Trial completion • Enrollment change
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IL6 (Interleukin 6) • IL2 (Interleukin 2)
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Neulasta (pegfilgrastim) • Azedra (iobenguane I 131)
5ms
Deciphering the structural impact of norepinephrine analog radiopharmaceuticals on organic cation transporter affinity. (PubMed, Biomed Pharmacother)
This study highlights the critical influence of the compounds' chemical structure on NET and OCT affinities. Structural modifications that reduce OCT-mediated uptake while maintaining high NET affinity could improve the specificity and theranostic potential of NET-targeting ligands. These findings provide insights for designing next-generation radiotracers with enhanced selectivity and clinical utility.
Journal
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SLC22A1 (Solute Carrier Family 22 Member 1) • SLC22A2 (Solute Carrier Family 22 Member 2)
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Azedra (iobenguane I 131)
6ms
Inbraced: Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma (clinicaltrials.gov)
P1, N=44, Active, not recruiting, University Hospital Southampton NHS Foundation Trust | Trial completion date: Jul 2025 --> Nov 2025
Trial completion date
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PD-L1 expression
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Opdivo (nivolumab) • Qarziba (dinutuximab beta) • Azedra (iobenguane I 131)
6ms
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
P3, N=750, Recruiting, Children's Oncology Group | Trial completion date: Sep 2026 --> Sep 2030 | Trial primary completion date: Sep 2026 --> Sep 2030
Trial completion date • Trial primary completion date
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
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cisplatin • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • dexrazoxane
6ms
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (clinicaltrials.gov)
P3, N=750, Recruiting, Children's Oncology Group | Active, not recruiting --> Recruiting
Enrollment open
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MYCN (MYCN Proto-Oncogene BHLH Transcription Factor)
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cisplatin • carboplatin • Lorbrena (lorlatinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • topotecan • thiotepa • Qarziba (dinutuximab beta) • busulfan • Azedra (iobenguane I 131) • Leukine (sargramostim) • captisol-enabled melphalan • dexrazoxane