Tracer library / [153Sm]Sm-EDTMP
[153Sm]Sm-EDTMP
Also written as Sm-153-EDTMP; [Sm-153]EDTMP
- Radionuclide
- Sm-153 t½ 2776.8 min
- Modality
- Therapy
- Production route
- —
- Stage
- Approved
- Syntheses indexed
- 3
What it is
Regulatory status
- FDA
- Yes — 1997; Quadramet (samarium Sm-153 lexidronam pentasodium); sponsor LANTHEUS MEDICAL; NDA 020570; openFDA marketing status: 'Discontinued' Drugs@FDA / openFDA drug registry, NDA 020570, original approval 1997-03-28 — https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA020570%22 (queried 2026-09-18); marketing status 'Discontinued'
- EMA (centralised)
- Yes — 1998; Quadramet (samarium (153Sm) lexidronam pentasodium); CIS bio international; EMEA/H/C/000150; register status 'Authorised' EMA medicines register (JSON export 2026-09-18), EPAR Quadramet: status 'Authorised', marketing authorisation date 1998-02-04 — https://www.ema.europa.eu/en/medicines/human/EPAR/quadramet
- Other approvals
- —
- Brand names
- —
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| Manual synthesis n/a | — | — | — | — | 152Sm | 29309920 2018 Nucl Med Biol A radiochemical separation procedure adopting electroamalgamation approach has been critically evaluated. |
| Manual synthesis n/a | — | — | ~98% | — | 152Sm | 21510750 2011 Cancer Biother Radiopharm They were labeled with EDTMP at varying degrees of pH and molar ratios, and labeling yields were determined by paper chromatography at each data point. - All the four radiopharmaceuticals gave ∼98% complex yields at pH 8. |
| — | — | — | — | 96.9 +/- 1.7% | EDTMP | 8358352 1993 Nucl Med Biol |
Clinical literature
Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.
- Comparative analysis of patients not responding to a single dose of 153Sm-EDTMP palliative treatment for painful skeletal metastases.2002 · Chin Med J (Engl) · Multicentre
- Multicentre trial on the efficacy and toxicity of single-dose samarium-153-ethylene diamine tetramethylene phosphonate as a palliative treatment for painful skeletal metastases in China.1999 · Eur J Nucl Med · Multicentre
- [Treatment of painful bony metastases with Samarium 153-EDTMP in prostate carcinoma].2007 · Tunis Med · Retrospective
- Percutaneous tumor curettage and interstitial delivery of samarium-153 coupled with kyphoplasty for treatment of vertebral metastases.2009 · J Neurosurg Spine · Clinical study
- [Cost-effectiveness of samarium-153-EDTMP for the treatment of pain due to multiple bone metastases in hormone-refractory prostate cancer versus conventional pain therapy, in Portugal].2006 · Acta Med Port · Clinical study
- [Cost-effectiveness analysis of samario-153 (Quadramet) for the treatment of patients with prostate cancer and bone metastases].2005 · Clin Transl Oncol · Clinical study
- High-activity samarium-153-EDTMP therapy followed by autologous peripheral blood stem cell support in unresectable osteosarcoma.2001 · Nuklearmedizin · Clinical study
- 153Sm-EDTMP and 186Re-HEDP as bone therapeutic radiopharmaceuticals.1987 · Int J Rad Appl Instrum B · Clinical study
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Added at stage 21 from therapy-discovered.xlsx (bulk PubMed search by isotope/therapy-type/known-agent, not individually researched yet) -- 15 articles found. Target/mechanism, clinical application, indications, approval and precursor fields still need per-agent research and are intentionally left empty. | Stage 31 (2026-09-18): Stage left 'Approved' -- the US product is marked 'Discontinued' in openFDA but the EU centralised authorisation is still 'Authorised'. The registers list the substance under its INN 'samarium (153Sm) lexidronam' (lexidronam = EDTMP); matched to this row by that INN.