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ammonia n-13

Small moleculeapproved

Approved

Aug 23, 2007

Clinical trial activity

9 trials · 13 clinical orgs · 32 marketing orgs

Phase 1
2
Phase 2
3
Phase 3
0
Phase 4
2

Earliest trial started Feb 1, 2011 (NCT01370265)

Timeline

2000s

  1. Aug 23, 2007

    Feinstein Institute for Medical Research — Earliest FDA Approval

  2. Aug 23, 2007

    Feinstein Institute for Medical Research — NDA Secondary Org

  3. Aug 23, 2007

    Feinstein Institute for Medical Research — NDA Organization

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Dec 14, 2012

    Houston Cyclotron — Marketing Organization

  3. Feb 25, 2013

    Cardinal Health — Marketing Organization

  4. Feb 25, 2013

    University of Pennsylvania — Marketing Organization

  5. Jun 27, 2013

    University of California, Los Angeles — Marketing Organization

  6. Dec 9, 2013

    Columbia University — Marketing Organization

  7. Jan 1, 2014

    Earliest Phase 2 Sponsor(trial)

  8. Feb 7, 2014

    Washington University in St. Louis — Marketing Organization

  9. Mar 28, 2014

    University of California, San Francisco — Marketing Organization

  10. Jun 27, 2014

    University of Texas at Houston — Marketing Organization

  11. Aug 19, 2014

    Johns Hopkins University — Marketing Organization

  12. Sep 19, 2014

    Shertech Labs Llc — Marketing Organization

  13. Oct 23, 2014

    Zevacor — Marketing Organization

  14. Oct 23, 2014

    Decatur Memorial Hospital — Marketing Organization

  15. Oct 30, 2014

    Harvard University — Marketing Organization

  16. Nov 20, 2014

    Stanford University — Marketing Organization

  17. Dec 18, 2014

    University of Wisconsin — Marketing Organization

  18. Feb 4, 2015

    NCM USA — Marketing Organization

  19. Apr 22, 2015

    Sofie — Marketing Organization

  20. Apr 23, 2015

    Spectron Mrc Llc — Marketing Organization

  21. Apr 23, 2015

    Nukemed — Marketing Organization

  22. May 1, 2015

    Biomedical Research Foundation — Marketing Organization

  23. Jun 23, 2015

    Central Radiopharmaceutical Services Inc. — Marketing Organization

  24. Aug 14, 2015

    Precision Nuclear — Marketing Organization

  25. Oct 19, 2015

    3d Imaging Drug Design & Development — Marketing Organization

  26. Nov 2, 2015

    Siemens — Marketing Organization

  27. Nov 18, 2015

    Midwest Medical Isotopes — Marketing Organization

  28. Dec 17, 2015

    Essential Isotopes, LLC — Marketing Organization

  29. Feb 3, 2016

    Gen Hosp — Marketing Organization

  30. Dec 21, 2018

    Ionetix — Marketing Organization

  31. Nov 1, 2019

    The University of Texas, Dallas — Marketing Organization

2020s

  1. Jul 9, 2021

    Methodist Cancer Center, Houston, Texas — Marketing Organization

  2. Nov 3, 2022

    University of Alabama, Birmingham — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 23, 2007

Chemistry & pharmacology

Loading structure…

SMILES

[13NH3]
Mol. weight
16.03 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (13n)ammonia
  • (13n)ammonia
  • 13n-ammonia
  • ammonia (13n)
  • ammonia (13n)
  • ammonia n 13
  • ammonia n 13
  • ammonia n 13
  • ammonia n-13
  • ammonia n-13
  • ammonia n-13
  • ammonia n-13
  • ammonia n-13
  • n-13 ammonia
  • n13 ammonia
  • nitrogen-13 ammonia

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05583721Phase 2Jan 31, 2023St. Jude Children's Hospital
NCT05625490Early Phase 1 (Phase 1)Nov 11, 2022National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Washington University in St. Louis
NCT03549598Phase 4Jul 20, 2018Mayo Clinic
NCT03275584Phase 4Jan 30, 2018University of Montreal
NCT03236311Phase 2Oct 12, 2017Sanofi
NCT02641145N/AApr 1, 2016American Heart Association, Harvard University, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
NCT02094001Phase 2May 1, 2014Bayer, University of Ottawa
NCT01433705Phase 1Nov 1, 2011University of Michigan
NCT01370265N/AFeb 1, 2011Astellas, Mayo Clinic
Showing 9 of 9 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mayo ClinicAcademic/Hospital2222011
National Heart, Lung, and Blood Institute (NHLBI)Government2022016
National Institutes of Health (NIH)Government2022016
American Heart AssociationAcademic/Hospital1012016
AstellasFor profit1012011
BayerFor profit1012014
Harvard UniversityAcademic/Hospital1112016
SanofiFor profit1112017
St. Jude Children's HospitalAcademic/Hospital1112023
University of MichiganAcademic/Hospital1112011
University of MontrealAcademic/Hospital1112018
University of OttawaAcademic/Hospital1112014
Washington University in St. LouisAcademic/Hospital1112022
13 organizations
Page 1 / 1

Marketing (36)

OrganizationOrg typeRelationshipDate
3d Imaging Drug Design & DevelopmentFor profitMKTGOct 19, 2015
Biomedical Research FoundationAcademic/HospitalMKTGMay 1, 2015
Cardinal HealthAcademic/HospitalMKTGFeb 25, 2013
Cardinal HealthAcademic/HospitalSYNFeb 25, 2013
Central Radiopharmaceutical Services Inc.For profitMKTGJun 23, 2015
Columbia UniversityAcademic/HospitalMKTGDec 9, 2013
Decatur Memorial HospitalAcademic/HospitalMKTGOct 23, 2014
Essential Isotopes, LLCFor profitMKTGDec 17, 2015
Feinstein Institute for Medical ResearchAcademic/HospitalNDA2Aug 23, 2007
Feinstein Institute for Medical ResearchAcademic/HospitalNDAAug 23, 2007
Gen HospAcademic/HospitalMKTGFeb 3, 2016
Harvard UniversityAcademic/HospitalMKTGOct 30, 2014
Houston CyclotronFor profitMKTGDec 14, 2012
IonetixFor profitMKTGDec 21, 2018
Johns Hopkins UniversityAcademic/HospitalMKTGAug 19, 2014
Methodist Cancer Center, Houston, TexasAcademic/HospitalMKTGJul 9, 2021
Midwest Medical IsotopesFor profitMKTGNov 18, 2015
NCM USAFor profitMKTGFeb 4, 2015
NukemedFor profitMKTGApr 23, 2015
Precision NuclearFor profitMKTGAug 14, 2015
Shertech Labs LlcFor profitMKTGSep 19, 2014
SiemensFor profitMKTGNov 2, 2015
SofieFor profitMKTGApr 22, 2015
Spectron Mrc LlcFor profitMKTGApr 23, 2015
Stanford UniversityAcademic/HospitalMKTGNov 20, 2014
The University of Texas, DallasAcademic/HospitalMKTGNov 1, 2019
University of Alabama, BirminghamAcademic/HospitalMKTGNov 3, 2022
University of California, Los AngelesAcademic/HospitalMKTGJun 27, 2013
University of California, San FranciscoAcademic/HospitalMKTGMar 28, 2014
University of PennsylvaniaAcademic/HospitalMKTGFeb 25, 2013
University of Texas at HoustonAcademic/HospitalMKTGJun 27, 2014
University of WisconsinAcademic/HospitalMKTGDec 18, 2014
University of WisconsinAcademic/HospitalMKTGSep 9, 2020
University of WisconsinAcademic/HospitalMKTGDec 18, 2014
Washington University in St. LouisAcademic/HospitalMKTGFeb 7, 2014
ZevacorFor profitMKTGOct 23, 2014