samarium-153 lexidronam
Trade name: quadramet
Small moleculeapprovedImaging agent
Approved
Mar 28, 1997
Samarium is a chemical element; it has symbol Sm and atomic number 62. It is a moderately hard silvery metal that slowly oxidizes in air. Being a typical member of the lanthanide series, samarium usually has the oxidation state +3. Compounds of samarium(II) are also known, most notably the monoxide SmO, monochalcogenides SmS, SmSe and SmTe, as well as samarium(II) iodide. — Wikipedia
Clinical trial activity
13 trials · 15 clinical orgs · 1 marketing orgs
Phase 1
6
Phase 2
12
Phase 3
1
Phase 4
0
Earliest trial started Mar 1, 1997 (NCT00003086)
Timeline
1990s
- Jan 1, 1997
Earliest Phase 1 Sponsor(trial)
- Mar 28, 1997
Lantheus Medical Imaging — Earliest FDA Approval
- Mar 28, 1997
Lantheus Medical Imaging — NDA Secondary Org
- Mar 28, 1997
Lantheus Medical Imaging — NDA Organization
Indications
Approved for
Mechanism of action
- BoneBINDING AGENT
Bone binding agent
Approval history
- approvedMar 28, 1997
Chemistry & pharmacology
- Mol. weight
- 695.93 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
- Imaging
- 153-samarium
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaSamarium ↗
- ChEMBLCHEMBL2109931 ↗
- ChEMBLCHEMBL2096660 ↗
- WikipediaSamarium (153Sm) lexidronam ↗
Also known as
- 153sm-edtmp
- 153sm-edtmp
- 153sm-edtmp
- cyt-424
- cyt-424
- quadramet
- quadramet
- quadramet
- quadramet
- quadramet
- samarate(5-)-153sm, (((1,2-ethanediylbis((nitrilo-kappa-n)bis(methylene)))tetrakis(phosphonato-kappa-o))(8-))-, pentahydrogen, (oc-6-21)
- samarium
- samarium
- samarium
- samarium-153-edtmp
- samarium-153 lexidronam
- samarium-153 lexidronam
- samarium-153 lexidronam
- samarium (153 sm) lexidronam
- samarium (153 sm) lexidronam
- samarium (153sm) lexidronam
- samarium (153sm) lexidronam
- samarium (153sm) lexidronam
- samarium (153sm) lexidronam
- samarium (153sm) lexidronam
- samarium (153sm) lexidronam pentasodium
- samarium [153sm] lexidronam pentasodium
- samarium [153sm] lexidronam pentasodium
- samarium [153sm] lexidronam pentasodium
- samarium [153sm] lexidronam pentasodium
- samarium [153sm] lexidronam pentasodium
- samarium ethylenediaminetetramethylenephosphonate
- samarium(ii) lexidronam
- samarium sm-153 lexidronam
- samarium sm-153 lexidronam
- samarium sm-153 lexidronam
- samarium sm 153 lexidronam pentasodium
- samarium sm 153 lexidronam pentasodium
- samarium sm 153 lexidronam pentasodium
- samarium sm-153 lexidronam pentasodium
- samarium sm-153 lexidronam pentasodium
- sm-153 lexidronam
- sm153 lexidronam
- sm153 lexidronam pentasodium
- sm-edtmp
- sm-edtmp
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01886105 | Phase 2 | Jun 1, 2013 | Johns Hopkins University |
| NCT00551525 | Phase 2 | Apr 1, 2008 | Harvard University, National Cancer Institute (NCI), NRG Oncology, Radiation Therapy Oncology Group, Thomas Jefferson University |
| NCT00429507 | Phase 2 | Mar 1, 2007 | Cytogen, University of Texas at Houston |
| NCT00450619 | Phase 2 | Feb 1, 2007 | National Cancer Institute (NCI), National Institutes of Health (NIH) |
| NCT00365105 | Phase 3 | Jul 1, 2006 | Akron City Hospital, National Cancer Institute (NCI), NRG Oncology, Radiation Therapy Oncology Group |
| NCT00316940 | Phase 1 | Dec 1, 2005 | Oncotherapeutics |
| NCT00478075 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2005 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT00121095 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2005 | Cornell University, Cytogen |
| NCT00482378 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2005 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT00245011 | Phase 2 | Oct 1, 2004 | Johns Hopkins University, National Cancer Institute (NCI) |
| NCT00126230 | Phase 2 | Jan 1, 2004 | Institut Gustave Roussy |
| NCT00602706 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2000 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT00003086 | Phase 1/Phase 2 (Phase 2) | Mar 1, 1997 | Louisiana State University |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (15)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 7 | 1 | 2 | 2000 |
| Mayo Clinic | Academic/Hospital | 3 | 3 | 1 | 2000 |
| Cytogen | For profit | 2 | 1 | 1 | 2005 |
| Johns Hopkins University | Academic/Hospital | 2 | 2 | 1 | 2004 |
| NRG Oncology | Academic/Hospital | 2 | 0 | 2 | 2006 |
| Radiation Therapy Oncology Group | Academic/Hospital | 2 | 2 | 2 | 2006 |
| Akron City Hospital | Academic/Hospital | 1 | 0 | 1 | 2006 |
| Cornell University | Academic/Hospital | 1 | 0 | 1 | 2005 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Institut Gustave Roussy | Academic/Hospital | 1 | 1 | 1 | 2004 |
| Louisiana State University | Academic/Hospital | 1 | 1 | 1 | 1997 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2007 |
| Oncotherapeutics | For profit | 1 | 1 | 1 | 2005 |
| Thomas Jefferson University | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2007 |
15 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Lantheus Medical Imaging | For profit | NDA2 | Mar 28, 1997 |
| Lantheus Medical Imaging | For profit | NDA | Mar 28, 1997 |