iobenguane sulfate i-131

Trade name: iobenguane sulfate i-131

Small moleculeapprovedOrphan Drug FDA

Approved

Mar 25, 1994

Iobenguane I-131 is a radioactive therapeutic agent. The drug contains radioactive isotope I-131, which decays by electron emission with a half-life of about 8 days. By the chemical structure, iobenguane is similar to the neurotransmitter norepinephrine and is subject to the same uptake and regulation pathways. After intravenous administration, iobenguane I-131 accumulates within pheochromocytoma and paraganglioma cells, and radiation from the radioactive decay causes cell death and tumor necrosis. Iobenguane I-131 was approved by the FDA for the treatment of adult and pediatric patients with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. Iobenguane I-131 is investigated in clinical trials as a treatment of neuroblastoma, ganglioneuroblastoma and other tumors of neuroendocrinal origin. — NCATS

Clinical trial activity

24 trials · 34 clinical orgs · 2 marketing orgs

Phase 1
7
Phase 2
15
Phase 3
2
Phase 4
0

Earliest trial started May 1, 1991 (NCT01413503)

Timeline

1980s

  1. Nov 14, 1984

    Orphan Drug Designation

1990s

  1. Jan 1, 1991

    Earliest Phase 2 Sponsor(trial)

  2. Mar 25, 1994

    Pharmalucence — Earliest FDA Approval

  3. Mar 25, 1994

    Pharmalucence — NDA Secondary Org

  4. Mar 25, 1994

    Pharmalucence — NDA Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jul 30, 2018

    Progenics — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedPriority reviewMar 25, 1994

Chemistry & pharmacology

Loading structure…

SMILES

N=C(N)NCc1cccc([131I])c1.N=C(N)NCc1cccc([131I])c1.O=S(=O)(O)O
Mol. weight
656.27 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 131i mibg
  • 131i mibg
  • 131i-mibg
  • 131i-mibg
  • i-131 metaiodobenzylguanidine (mibg)
  • i-131 mibg
  • i-131 mibg
  • iobenguane (131i)
  • iobenguane (131i)
  • iobenguane (131i)
  • iobenguane (131i)
  • iobenguane (131i)
  • iobenguane i 131
  • iobenguane i 131
  • iobenguane i 131
  • iobenguane i 131
  • iobenguane i-131
  • iobenguane i-131
  • iobenguane i-131
  • iobenguane sulfate (131i)
  • iobenguane sulfate (131i)
  • iobenguane sulfate i 131
  • iobenguane sulfate i 131
  • iobenguane sulfate i 131
  • iobenguane sulfate i-131
  • m131ibg
  • m131ibg

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07261241Phase 2Jul 31, 2026Jubilant DraxImage Inc., National Cancer Institute (NCI), United Therapeutics
NCT04614766Phase 1/Phase 2 (Phase 2)Nov 1, 2020National Cancer Institute (NCI), National Institutes of Health (NIH), Progenics, University of Iowa
NCT03561259Phase 2Jul 31, 2018Jubilant DraxImage Inc.
NCT03126916Phase 3Aug 1, 2017National Cancer Institute (NCI)
NCT03165292Phase 2Jun 1, 2017Institut Gustave Roussy, National Cancer Institute, France
NCT03044977Early Phase 1 (Phase 1)May 7, 2017National Cancer Institute (NCI), National Institutes of Health (NIH), University of Iowa
NCT01941849Phase 1Oct 1, 2014AstraZeneca, Cancer Research UK, University of London
NCT02035137Phase 2Jul 1, 2014Harvard University, National Cancer Institute (NCI)
NCT01838187N/AApr 8, 2013University of Cincinnati
NCT01590680N/AMay 1, 2012Cook Children's Medical Center, Duke University, Emory University, Harvard University, Jubilant DraxImage Inc., The University of Texas, Dallas, University of Chicago, University of Cincinnati, University of Colorado, University of Michigan, University of Washington, University of Wisconsin, Vanderbilt University
NCT01175356N/AOct 1, 2010National Cancer Institute (NCI)
NCT03061656Phase 2Jan 1, 2009Government of Korea, Sungkyunkwan University
NCT00960739Phase 2Nov 1, 2008National Cancer Institute, France, Novartis, University of Lille
NCT00798148Phase 1/Phase 2 (Phase 2)Sep 1, 2008Isfahan University
NCT00526318N/AJan 1, 2007Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany, University of Cincinnati
NCT00509353Phase 1Jan 1, 2007National Cancer Institute (NCI), University of California, San Francisco, University of Southern California
NCT00107289Phase 2May 1, 2006Cornell University, National Cancer Institute (NCI)
NCT00253435Phase 2Sep 1, 2005National Cancer Institute (NCI), University of California, San Francisco, University of Michigan, University of Pennsylvania, University of Southern California
NCT00293319Phase 2Apr 1, 2005National Cancer Institute (NCI), University of California, San Francisco, University of Pennsylvania
NCT00410631Phase 3Oct 1, 2004Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany, University of Cincinnati
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (34)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government12542000
University of California, San FranciscoAcademic/Hospital5221991
University of CincinnatiAcademic/Hospital4122004
University of Southern CaliforniaAcademic/Hospital4322000
Jubilant DraxImage Inc.For profit3222012
University of MichiganAcademic/Hospital3032004
University of PennsylvaniaAcademic/Hospital3022004
Gesellschaft fur Padiatrische Onkologie und Hamatologie - GermanyAcademic/Hospital2222004
Harvard UniversityAcademic/Hospital2022012
National Cancer Institute, FranceGovernment2012008
National Institutes of Health (NIH)Government2022017
University of IowaAcademic/Hospital2222017
AstraZenecaFor profit1012014
Cancer Research UKAcademic/Hospital1012014
Cook Children's Medical CenterAcademic/Hospital1012012
Cornell UniversityAcademic/Hospital1112006
Duke UniversityAcademic/Hospital1012012
Emory UniversityAcademic/Hospital1012012
Government of KoreaGovernment1012009
Institut Gustave RoussyAcademic/Hospital1112017
34 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
PharmalucenceFor profitNDA2Mar 25, 1994
PharmalucenceFor profitNDAMar 25, 1994
ProgenicsFor profitNDA2Jul 30, 2018