iobenguane (123i)
Approved
Sep 19, 2008
IOBENGUANE I-123 (AdreView®) is a radiopharmaceutical agent for gamma-scintigraphy. It is similar in structure to the antihypertensive drug guanethidine and to the neurotransmitter norepinephrine (NE). IOBENGUANE is, therefore, largely subject to the same uptake and accumulation pathways as NE. It is taken up by the NE transporter in adrenergic nerve terminals and stored in the presynaptic storage vesicles. IOBENGUANE accumulates in adrenergically innervated tissues such as the adrenal medulla, salivary glands, heart, liver, spleen, and lungs as well as tumors derived from the neural crest. By labeling IOBENGUANE with the isotope iodine 123 (I-123), it is possible to obtain scintigraphic images of the organs and tissues in which the radiopharmaceutical accumulates. IOBENGUANE I-123 (AdreView®) is indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma. It is also used for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, IOBENGUANE I-123 (AdreView®) may be used to help identify patients with lower one and two-year mortality risks, as indicated by an H/M ratio ≥ 1.6. — NCATS
Clinical trial activity
20 trials · 23 clinical orgs · 2 marketing orgs
Earliest trial started Dec 5, 2001 (NCT00028106)
Timeline
2000s
- Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
General Electric — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2006
Earliest Phase 1 Sponsor(trial)
- Dec 1, 2006
Orphan Drug Designation
- Sep 19, 2008
General Electric — Earliest FDA Approval
- Sep 19, 2008
General Electric — NDA Secondary Org
- Sep 19, 2008
General Electric — NDA Organization
2020s
- Dec 9, 2024
BWXT — Marketing Organization
Indications
Approved for
Mechanism of action
- Catechol 2,3-dioxygenaseBINDING AGENT
xylE binding agent
Approval history
- approvedPriority reviewSep 19, 2008
Chemistry & pharmacology
SMILES
NC(=N)NCC1=CC=CC([123I])=C1- Mol. weight
- 271.0907 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Imaging
- 131-iodine
Oral
No
Parenteral
No
Topical
No
Sources
- NCATSP2TH1XYZ84 ↗
- ChEMBLCHEMBL818 ↗
- ChEMBLCHEMBL1615777 ↗
- ChEMBLCHEMBL1201730 ↗
Also known as
- 123i metaiodobenzylguanidine
- 123i-metaiodobenzylguanidine
- 3-iodobenzylguanidine
- 3-iodobenzylguanidine
- ((3-iodophenyl)methyl)guanidine
- ((3-iodophenyl)methyl)guanidine
- adreview
- adreview
- adreview
- i-123 metaiodobenzylguanidine
- i-123 mibg
- i-123-mibg
- iobenguane
- iobenguane
- iobenguane
- iobenguane
- iobenguane
- iobenguane (123i)
- iobenguane (123i)
- iobenguane i 123
- iobenguane i 123
- iobenguane i 123
- iobenguane i-123
- iobenguane i 123 injection
- iobenguane i 123 injection
- iobenguane sulfate
- iobenguane sulfate
- iobenguane sulfate (123i)
- iobenguane sulfate (123i)
- iobenguane sulfate i 123
- iobenguane sulfate i 123
- iobenguane sulfate i 123
- iobenguane sulfate i 123
- iobenguane sulfate i-123
- iobenguane sulfate i-123
- iobenguane sulfate i-123
- iobenguane sulfate i-123
- iobenguane sulfate i-123
- iobenguane sulfate i-123
- iodobenzylguanidine sulfate (123i)
- iodobenzylguanidine sulfate (123i)
- metaiodobenzylguanidine
- metaiodobenzylguanidine
- mibg
- mibg
- mibg-i-123
- mibg-i-123
- m-iodobenzylguanidine
- m-iodobenzylguanidine
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04510311 | Early Phase 1 (Phase 1) | Oct 19, 2020 | University of Michigan |
| NCT02961491 | N/A | Nov 8, 2016 | Molecular Insight Pharmaceuticals |
| NCT02656329 | Phase 3 | Jan 1, 2016 | General Electric, ICON, TFS Trial Form Support |
| NCT01868841 | Phase 4 | Dec 1, 2013 | Aspire Foundation, Cardiovascular Imaging Technologies, General Electric |
| NCT01936649 | Phase 4 | Aug 1, 2013 | General Electric, H2O Clinical LLC, IQVIA |
| NCT02515812 | N/A | Oct 1, 2012 | University of Caen-Normandie |
| NCT01522378 | Phase 1 | Feb 1, 2012 | General Electric, Mayo Clinic |
| NCT01432626 | N/A | Sep 1, 2011 | General Electric, University of Pittsburgh |
| NCT01373736 | Phase 3 | Jun 13, 2011 | Vancouver Coastal Health |
| NCT01250912 | N/A | Mar 1, 2010 | General Electric, University of Maryland |
| NCT00992173 | Phase 2 | Jan 1, 2010 | Molecular Insight Pharmaceuticals |
| NCT00874614 | Phase 2 | Jun 1, 2009 | Duke University, Icahn School of Medicine at Mount Sinai, Johns Hopkins University, Molecular Insight Pharmaceuticals, University of California, San Francisco, University of Iowa, University of Pennsylvania, University of Texas at Houston, Washington University in St. Louis |
| NCT00730444 | N/A | Aug 5, 2008 | General Electric |
| NCT00659984 | Phase 2 | Jun 1, 2008 | Molecular Insight Pharmaceuticals, University of California, San Francisco |
| NCT00458952 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2007 | Molecular Insight Pharmaceuticals |
| NCT00339131 | Phase 1 | Jun 1, 2006 | Duke University, Molecular Insight Pharmaceuticals |
| NCT00126412 | Phase 3 | Jul 1, 2005 | General Electric |
| NCT00126438 | Phase 3 | Jul 1, 2005 | General Electric |
| NCT00126425 | Phase 3 | Jul 1, 2005 | General Electric |
| NCT00028106 | Phase 2 | Dec 5, 2001 | National Institutes of Health (NIH) |
Organizations
Research & Development (23)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| General Electric | For profit | 10 | 6 | 4 | 2005 |
| Molecular Insight Pharmaceuticals | For profit | 6 | 6 | 3 | 2006 |
| Duke University | Academic/Hospital | 2 | 0 | 2 | 2006 |
| University of California, San Francisco | Academic/Hospital | 2 | 0 | 1 | 2008 |
| Aspire Foundation | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Cardiovascular Imaging Technologies | For profit | 1 | 1 | 1 | 2013 |
| H2O Clinical LLC | For profit | 1 | 0 | 1 | 2013 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 1 | 0 | 1 | 2009 |
| ICON | For profit | 1 | 0 | 1 | 2016 |
| IQVIA | For profit | 1 | 0 | 1 | 2013 |
| Johns Hopkins University | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2012 |
| National Institutes of Health (NIH) | Government | 1 | 1 | 1 | 2001 |
| TFS Trial Form Support | For profit | 1 | 0 | 1 | 2016 |
| University of Caen-Normandie | Academic/Hospital | 1 | 1 | 1 | 2012 |
| University of Iowa | Academic/Hospital | 1 | 0 | 1 | 2009 |
| University of Maryland | Academic/Hospital | 1 | 1 | 1 | 2010 |
| University of Michigan | Academic/Hospital | 1 | 1 | 1 | 2020 |
| University of Pennsylvania | Academic/Hospital | 1 | 0 | 1 | 2009 |
| University of Pittsburgh | Academic/Hospital | 1 | 1 | 1 | 2011 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| BWXT | For profit | MKTG | Dec 9, 2024 |
| General Electric | For profit | NDA2 | Sep 19, 2008 |
| General Electric | For profit | NDA | Sep 19, 2008 |