SAR-bisPSMA
64Cu-SAR-bisPSMA: a bivalent PSMA PET agent with a long-lived copper-64 label, in phase 3 trials for prostate cancer; investigational.
SAR-bisPSMA is a bivalent PSMA-targeting peptide that holds copper. Labelled with copper-64, whose 12.7-hour half-life allows later imaging, it is a PET agent for prostate cancer; a prospective trial in 50 men with low-PSA biochemical recurrence after prostatectomy compared it with gallium-68 PSMA-11. Phase 3 trials are listed on ClinicalTrials.gov, and copper-67 SAR-bisPSMA is being tested as a therapy. It is not approved.
No dosing data yet Details ↓
Recommended Dosing
No dosing data yet
This page has no dosing data yet.
Mechanism of action
Binds prostate-specific membrane antigen through two binding motifs (2026 trial: a bivalent PSMA peptide).
Primary uses
- Investigational: PSMA PET in primary and recurrent prostate cancer
- Investigational: copper-67 radioligand therapy
Typical dosing
The abstracts read report the radioactivity given per patient or per study arm without a fixed amount to quote here, so none is given.
Regulatory status
Not approved: Drugs@FDA and the EMA medicines list hold no record (searched October 28, 2026). ClinicalTrials.gov lists phase 3 trials NCT06056830 (recruiting) and NCT06970847 (active, not recruiting), and NCT04868604 (phase 1/2, copper-64 and copper-67).
Status as of this entry's last review, October 28, 2026. Approvals, compounding rules and sport rules change; the regulatory tracker is checked more often.
What we checked
SAR-bisPSMA is a radiopharmaceutical; this section records what can be checked.
Identity, computed
| Radionuclides | copper-64 for PET, copper-67 for therapy (ClinicalTrials.gov) |
| Copper-64 half-life | 12.7 hours (2026 trial) |
PubChem returned no record under this name on the read date, so no formula is given.
Regulatory status, read October 29, 2026
Drugs@FDA: 0 records for “bispsma”. EMA medicines list: 0 records for “bispsma”. Run for semaglutide, the same queries return 6 and 5 records (and the registry search 81 trials), so a zero here is an absence, not a broken search. Not named on the WADA 2026 and 2027 Prohibited Lists. As a substance with no current approval for human therapeutic use, it falls under section S0 (non-approved substances), which is prohibited at all times; the lists were read on October 28, 2026.
What the studies show
Co-PSMA: copper-64 SAR-bisPSMA against gallium-68 PSMA-11 in 50 men with biochemical recurrence after prostatectomy (Khan et al., 2026).
Optimising administered activity in primary prostate cancer (PROPELLER sub-study) (Lengyelova et al., 2026).
What we looked for and did not find
No approval under this name.
| Source | Query | Results, October 29, 2026 | What it was |
|---|---|---|---|
| PubMed | "SAR-bisPSMA"[tiab] | 4 | |
| ClinicalTrials.gov | SAR-bisPSMA | 7 | |
| Drugs@FDA (openFDA) | bispsma | 0 | |
| EMA medicines list | bispsma | 0 |
References
- [clinical-trial] Khan S, et al. "Prospective Comparison of (64)Copper [(64)Cu]SAR-bisPSMA vs (68)Gallium[(68)Ga] PSMA-11 PET/CT for Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy (Co-PSMA Trial)." Eur Urol, 2026;89(6):512-520. PMID: 41904043.
- [pubmed] Lengyelova E, et al. "Optimization of Administered Activity for (64) Cu-SAR-bisPSMA PET Imaging in Primary Prostate Cancer: Results from a Phase I Retrospective Study (PROPELLER Sub-study)." World J Nucl Med, 2026;25(2):107-114. PMID: 42395167.
- [registry] ClinicalTrials.gov API v2, read October 28, 2026: NCT06056830 (phase 3, high-risk prostate cancer before prostatectomy, recruiting); NCT06970847 (phase 3, biochemical recurrence, active, not recruiting); NCT04868604 (phase 1/2, copper-64 and copper-67 SAR-bisPSMA, recruiting).
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This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.