selenomethionine se-75
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
Earliest trial started Feb 1, 2000 (NCT00030901)
Timeline
1970s
- May 7, 1973
Bracco — Earliest FDA Approval
- May 7, 1973
Bracco — NDA Secondary Org
- May 7, 1973
Mallinckrodt — NDA Secondary Org
- May 7, 1973
Bracco — NDA Organization
- Nov 9, 1976
General Electric — Marketing Organization
- Nov 9, 1976
General Electric — NDA Secondary Org
2010s
- Jan 1, 2010
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Carcinoma, Renal Cell · Phase 1/Phase 2
- Carcinoma, Squamous Cell · Phase 2
- Colorectal Neoplasms · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Irritable Bowel Syndrome · Phase 2
- Lung Neoplasms · Phase 2
- Lymphoma, Follicular · Phase 2
- Mucositis · Phase 2
- Precancerous Conditions · Phase 3
- Prostatic Neoplasms · Phase 3
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Thyroiditis, Autoimmune · Phase 4
- Xerostomia · Phase 2
Mechanism of action
- PancreasRadiopharmaceutical
Pancreas radiopharmaceutical
Approval history
- approvedPriority reviewMay 7, 1973
Chemistry & pharmacology
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
- ChEMBLCHEMBL113178 ↗
- NCATS964MRK2PEL ↗
- ChEMBLCHEMBL1201054 ↗
- NCATSP6708E7555 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05363631 | Phase 1/Phase 2 (Phase 2) | Sep 19, 2022 | University of Iowa |
| NCT04952129 | Phase 1 | Aug 1, 2021 | Cancer Trials New Zealand, Counties Manukau Health, University of Auckland, Waikato Hospital |
| NCT02535533 | Phase 1 | Jan 1, 2016 | University of Iowa |
| NCT02644707 | Phase 4 | Mar 1, 2015 | Aristotle University of Thessaloniki |
| NCT02302768 | Phase 2 | Dec 1, 2012 | IBSA Institut Biochimique SA, University of Siena |
| NCT01167673 | Phase 2 | Apr 1, 2011 | Meir Medical Center, Tel Aviv University |
| NCT01211561 | Early Phase 1 (Phase 1) | Dec 1, 2010 | University of Illinois at Chicago |
| NCT01682031 | Phase 2 | Jun 1, 2009 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT00793130 | N/A | Nov 1, 2008 | Tel Aviv University |
| NCT00736645 | Phase 2 | Aug 1, 2008 | State University of New York, Buffalo |
| NCT00736164 | Phase 2 | Aug 1, 2008 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT00625183 | Phase 2 | Mar 1, 2008 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT00455416 | Phase 2 | Apr 1, 2007 | Osaka University, University of Oslo |
| NCT00526890 | Phase 2 | Oct 1, 2006 | State University of New York, Buffalo |
| NCT00271245 | N/A | Feb 1, 2006 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Vanderbilt University |
| NCT00803699 | N/A | Nov 1, 2005 | National Cancer Institute (NCI), United States Department of Agriculture |
| NCT00271427 | N/A | Dec 1, 2004 | Ege University, Saglik Bilimleri Universitesi |
| NCT00030901 | Phase 3 | Feb 1, 2000 | Cancer 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 |
Organizations
Research & Development (25)
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bracco | For profit | NDA2 | May 7, 1973 |
| Bracco | For profit | NDA | May 7, 1973 |
| General Electric | For profit | MKTG | Nov 9, 1976 |
| General Electric | For profit | NDA2 | Nov 9, 1976 |
| Mallinckrodt | For profit | NDA2 | May 7, 1973 |
| Pharmalucence | For profit | NDA2 | — |