selenomethionine se-75

Small moleculeapprovedImaging agent

Approved

May 7, 1973

L-isomer of selenomethionine (Se-met) is a major natural food-form of selenium, synthetic L-Se-met or enriched food sources thereof such as selenium yeast are appropriate supplemental forms of Se for humans; for animals, DL-Se-met is acceptable. Ingested Se-met is either metabolized directly to reactive forms of selenium or stored in place of methionine in body proteins. Se-met metabolism is closely linked to protein turnover. Selenium, which is nutritionally essential for humans, is a constituent of more than two dozen selenoproteins that play critical roles in reproduction, thyroid hormone metabolism, DNA synthesis, and protection from oxidative damage and infection. — NCATS

Clinical trial activity

18 trials · 25 clinical orgs · 4 marketing orgs

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

Earliest trial started Feb 1, 2000 (NCT00030901)

Timeline

1970s

  1. May 7, 1973

    Bracco — Earliest FDA Approval

  2. May 7, 1973

    Bracco — NDA Secondary Org

  3. May 7, 1973

    Mallinckrodt — NDA Secondary Org

  4. May 7, 1973

    Bracco — NDA Organization

  5. Nov 9, 1976

    General Electric — Marketing Organization

  6. Nov 9, 1976

    General Electric — NDA Secondary Org

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

  • PancreasRadiopharmaceutical

    Pancreas radiopharmaceutical

Approval history

  • approvedPriority reviewMay 7, 1973

Chemistry & pharmacology

Loading structure…

SMILES

C[Se]CC[C@H](N)C(=O)O
Mol. weight
196.11 g/mol
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued
Imaging
75-selenium

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 75se
  • 75se
  • l-selenomethionine
  • l-selenomethionine
  • l-selenomethionine
  • radioselenomethionine (75se)
  • radioselenomethionine (75se)
  • selenomax
  • selenomethionine
  • selenomethionine
  • selenomethionine
  • selenomethionine
  • selenomethionine
  • selenomethionine
  • selenomethionine
  • selenomethionine (75se)
  • selenomethionine (75se)
  • selenomethionine (75se) injection
  • selenomethionine (75se) injection
  • selenomethionine se 75
  • selenomethionine se 75
  • selenomethionine se-75
  • selenomethionine se-75
  • selenomethionine se-75
  • sethotope
  • sethotope
  • vitaselenium

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05363631Phase 1/Phase 2 (Phase 2)Sep 19, 2022University of Iowa
NCT04952129Phase 1Aug 1, 2021Cancer Trials New Zealand, Counties Manukau Health, University of Auckland, Waikato Hospital
NCT02535533Phase 1Jan 1, 2016University of Iowa
NCT02644707Phase 4Mar 1, 2015Aristotle University of Thessaloniki
NCT02302768Phase 2Dec 1, 2012IBSA Institut Biochimique SA, University of Siena
NCT01167673Phase 2Apr 1, 2011Meir Medical Center, Tel Aviv University
NCT01211561Early Phase 1 (Phase 1)Dec 1, 2010University of Illinois at Chicago
NCT01682031Phase 2Jun 1, 2009National Cancer Institute (NCI), State University of New York, Buffalo
NCT00793130N/ANov 1, 2008Tel Aviv University
NCT00736645Phase 2Aug 1, 2008State University of New York, Buffalo
NCT00736164Phase 2Aug 1, 2008National Cancer Institute (NCI), State University of New York, Buffalo
NCT00625183Phase 2Mar 1, 2008National Cancer Institute (NCI), State University of New York, Buffalo
NCT00455416Phase 2Apr 1, 2007Osaka University, University of Oslo
NCT00526890Phase 2Oct 1, 2006State University of New York, Buffalo
NCT00271245N/AFeb 1, 2006National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Vanderbilt University
NCT00803699N/ANov 1, 2005National Cancer Institute (NCI), United States Department of Agriculture
NCT00271427N/ADec 1, 2004Ege University, Saglik Bilimleri Universitesi
NCT00030901Phase 3Feb 1, 2000Cancer and Leukemia Group B (CALGB), Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Southwest Oncology Group, State University of New York, Buffalo, University of Wisconsin, Wake Forest University
Showing 18 of 18 trials
Page 1 / 1

Organizations

Research & Development (25)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
State University of New York, BuffaloAcademic/Hospital6522000
National Cancer Institute (NCI)Government5032000
Tel Aviv UniversityAcademic/Hospital2122008
University of IowaAcademic/Hospital2222016
Aristotle University of ThessalonikiAcademic/Hospital1112015
Cancer and Leukemia Group B (CALGB)Academic/Hospital1012000
Cancer Trials New ZealandAcademic/Hospital1012021
Counties Manukau HealthGovernment1012021
Eastern Cooperative Oncology GroupAcademic/Hospital1012000
Ege UniversityAcademic/Hospital1112004
IBSA Institut Biochimique SAFor profit1012012
Meir Medical CenterAcademic/Hospital1112011
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1012006
Osaka UniversityAcademic/Hospital1112007
Saglik Bilimleri UniversitesiAcademic/Hospital1012004
Southwest Oncology GroupAcademic/Hospital1112000
United States Department of AgricultureGovernment1112005
University of AucklandAcademic/Hospital1112021
University of Illinois at ChicagoAcademic/Hospital1112010
University of OsloAcademic/Hospital1012007
25 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
BraccoFor profitNDA2May 7, 1973
BraccoFor profitNDAMay 7, 1973
General ElectricFor profitMKTGNov 9, 1976
General ElectricFor profitNDA2Nov 9, 1976
MallinckrodtFor profitNDA2May 7, 1973
PharmalucenceFor profitNDA2