iobenguane (123i)

Small moleculeapprovedImaging agentOrphan Drug FDA

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

Phase 1
4
Phase 2
10
Phase 3
5
Phase 4
2

Earliest trial started Dec 5, 2001 (NCT00028106)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2005

    General Electric — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  4. Dec 1, 2006

    Orphan Drug Designation

  5. Sep 19, 2008

    General Electric — Earliest FDA Approval

  6. Sep 19, 2008

    General Electric — NDA Secondary Org

  7. Sep 19, 2008

    General Electric — NDA Organization

2020s

  1. Dec 9, 2024

    BWXT — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewSep 19, 2008

Chemistry & pharmacology

Loading structure…

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

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 IDPhaseStart dateSponsor(s)
NCT04510311Early Phase 1 (Phase 1)Oct 19, 2020University of Michigan
NCT02961491N/ANov 8, 2016Molecular Insight Pharmaceuticals
NCT02656329Phase 3Jan 1, 2016General Electric, ICON, TFS Trial Form Support
NCT01868841Phase 4Dec 1, 2013Aspire Foundation, Cardiovascular Imaging Technologies, General Electric
NCT01936649Phase 4Aug 1, 2013General Electric, H2O Clinical LLC, IQVIA
NCT02515812N/AOct 1, 2012University of Caen-Normandie
NCT01522378Phase 1Feb 1, 2012General Electric, Mayo Clinic
NCT01432626N/ASep 1, 2011General Electric, University of Pittsburgh
NCT01373736Phase 3Jun 13, 2011Vancouver Coastal Health
NCT01250912N/AMar 1, 2010General Electric, University of Maryland
NCT00992173Phase 2Jan 1, 2010Molecular Insight Pharmaceuticals
NCT00874614Phase 2Jun 1, 2009Duke 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
NCT00730444N/AAug 5, 2008General Electric
NCT00659984Phase 2Jun 1, 2008Molecular Insight Pharmaceuticals, University of California, San Francisco
NCT00458952Phase 1/Phase 2 (Phase 2)Apr 1, 2007Molecular Insight Pharmaceuticals
NCT00339131Phase 1Jun 1, 2006Duke University, Molecular Insight Pharmaceuticals
NCT00126412Phase 3Jul 1, 2005General Electric
NCT00126438Phase 3Jul 1, 2005General Electric
NCT00126425Phase 3Jul 1, 2005General Electric
NCT00028106Phase 2Dec 5, 2001National Institutes of Health (NIH)
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
General ElectricFor profit10642005
Molecular Insight PharmaceuticalsFor profit6632006
Duke UniversityAcademic/Hospital2022006
University of California, San FranciscoAcademic/Hospital2012008
Aspire FoundationAcademic/Hospital1012013
Cardiovascular Imaging TechnologiesFor profit1112013
H2O Clinical LLCFor profit1012013
Icahn School of Medicine at Mount SinaiAcademic/Hospital1012009
ICONFor profit1012016
IQVIAFor profit1012013
Johns Hopkins UniversityAcademic/Hospital1012009
Mayo ClinicAcademic/Hospital1112012
National Institutes of Health (NIH)Government1112001
TFS Trial Form SupportFor profit1012016
University of Caen-NormandieAcademic/Hospital1112012
University of IowaAcademic/Hospital1012009
University of MarylandAcademic/Hospital1112010
University of MichiganAcademic/Hospital1112020
University of PennsylvaniaAcademic/Hospital1012009
University of PittsburghAcademic/Hospital1112011
23 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
BWXTFor profitMKTGDec 9, 2024
General ElectricFor profitNDA2Sep 19, 2008
General ElectricFor profitNDASep 19, 2008