Iobenguane I 131 is under clinical development by Lantheus Holdings and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Iobenguane I 131’s likelihood of approval (LoA) and phase transition for Neuroblastoma took place on 14 Sep 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Iobenguane I 131 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Iobenguane I 131 overview

Iobenguane I 131 (Azedra) is a therapeutic radio-pharmaceutical agent. It is formulated as injectable solution for intravenous route of administration. Azedra is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Ultratrace Iobenguane I 131 is under development for the treatment of neuroblastoma. The drug candidate is administered as an intravenous injection. It is a small molecule, targeted radiotherapeutic based on the known I-131 MIBG molecule developed based on Ultratrace technology which is a technique that avoids large quantities of non-radioactive iobenguane in the formulation of the product. It was under development for the treatment of neuroblastoma (EU).

Lantheus Holdings overview

Lantheus Holdings (Lantheus) is engaged in the development, manufacture, sale and distribution of diagnostic medical imaging agents and products that assist clinicians in the diagnosis of cardiovascular and other diseases. The company offers products including DEFINITY, VIALMIX, PINSYNC, TechneLite, Xenon-133, Calidose Dispenser System, NEUROLITE, Thallium-201, QUADRAMET, Cardiolite, Gallium-67, Fludeoxyglucose F 18 Injection and ABLAVAR. Lantheus sells its products to radiopharmacies, hospitals, clinics, group practices, integrated delivery networks, group purchasing organizations, and wholesalers. The company has operations in the US, Puerto Rico, Canada and Australia and distribution relationships in Europe, Asia Pacific and Latin America. Lantheus is headquartered in North Billerica, Massachusetts, the US.

Quick View Iobenguane I 131 LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Iobenguane I 131
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Lantheus Holdings
  • Originator: Molecular Insight Pharmaceuticals
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.