Iobenguane

Overview

Synthetic guanethidine derivative that locates phaeochromocytomas and neuroblastomas. The radioisotope used can either be iodine-123 for imaging or iodine-131 for destruction of tissues that metabolize noradrenaline. Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture. Images are produced by a I123 MIBG scintigraphy. FDA approved on September 19, 2008.

Indication

Detection of primary and metastatic pheochromocytoma or neuroblastoma

Associated Conditions

Metastatic Adrenal Gland Pheochromocytoma
Metastatic Neuroblastoma
Primary Neuroblastomas
Primary Pheochromocytomas
Unresectable, locally advanced iobenguane-scan positive Paraganglioma
Unresectable, locally advanced iobenguane-scan positive Pheochromocytomas
Unresectable, metastatic iobenguane-scan positive Paraganglioma
Unresectable, metastatic iobenguane-scan positive Pheochromocytomas

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors	2020/11/04	NCT04614766	Phase 1	Withdrawn	David Bushnell
Imaging Properties of PET Radiotracer [18F]3F-PHPG in Patients With Neuroendocrine Tumors	2020/08/12	NCT04510311	Early Phase 1	Completed	University of Michigan Rogel Cancer Center
Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma	2016/11/11	NCT02961491	N/A	APPROVED_FOR_MARKETING	Molecular Insight Pharmaceuticals, Inc.
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device	2016/01/14	NCT02656329	Phase 3	Terminated	GE Healthcare
MIBG Therapy for Patients With MIBG Avid Tumors	2015/03/04	NCT02378428	Phase 2	Active, not recruiting	Nationwide Children's Hospital
131I-Labeled MIBG for Refractory Neuroblastoma: A Compassionate Use Protocol	2011/06/09	NCT01370330	N/A	AVAILABLE	Kieuhoa Vo
High-Dose 131I-MIBG Therapy Combined With Vincristine and Five Days of Irinotecan for Resistant/Relapsed Neuroblastoma	2011/03/14	NCT01313936	Phase 1	Completed	University of California, San Francisco
Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma	2009/10/09	NCT00992173	Phase 2	Withdrawn	Molecular Insight Pharmaceuticals, Inc.
Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma	2008/08/08	NCT00730444	N/A	APPROVED_FOR_MARKETING	GE Healthcare
N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma	2008/04/17	NCT00659984	Phase 2	Completed	Molecular Insight Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
META-IODOBENZYLGUANIDINE (I-131) INJECTION FOR THERAPEUTIC USE	GE HEALTHCARE BUCHLER GMBH & CO KG	SIN11963P	INJECTION	0.185 - 0.740 GBq/ml	5/28/2002

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MIBGEN iobenguane[123I] sulfate 100MBq/mL injection	101670	Australian Nuclear Science and Technology Organisation T/A ANSTO	Medicine	A	6/3/2004

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

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3 months ago

The FDA has approved belzutifan (Welireg) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma, based on promising phase 2 trial results.

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