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64Cu-SAR-bisPSMA
64Cu-SAR-bisPSMA is a Radiopharmaceutical; PET imaging agent Small molecule drug developed by Clarity Pharmaceuticals Ltd. It is currently in Phase 3 development for PET imaging of PSMA-positive prostate cancer, Detection and localization of metastatic prostate cancer lesions.
64Cu-SAR-bisPSMA is a copper-64 labeled radiopharmaceutical that binds to prostate-specific membrane antigen (PSMA) for positron emission tomography (PET) imaging of PSMA-expressing tumors.
64Cu-SAR-bisPSMA is a copper-64 labeled radiopharmaceutical that binds to prostate-specific membrane antigen (PSMA) for positron emission tomography (PET) imaging of PSMA-expressing tumors. Used for PET imaging of PSMA-positive prostate cancer, Detection and localization of metastatic prostate cancer lesions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | 64Cu-SAR-bisPSMA |
|---|---|
| Sponsor | Clarity Pharmaceuticals Ltd |
| Drug class | Radiopharmaceutical; PET imaging agent |
| Target | PSMA (prostate-specific membrane antigen) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This agent combines a copper-64 radionuclide with a bisPSMA targeting ligand that selectively binds to PSMA, a cell-surface antigen highly expressed on prostate cancer cells. The radioactive copper-64 enables PET imaging to detect and localize PSMA-positive lesions, facilitating diagnostic imaging and treatment planning. The bisPSMA design provides enhanced binding affinity and specificity for improved tumor visualization.
Approved indications
- PET imaging of PSMA-positive prostate cancer
- Detection and localization of metastatic prostate cancer lesions
Common side effects
Key clinical trials
- 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer (PHASE3)
- Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (PHASE3)
- 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) (PHASE1, PHASE2)
- Comparative Performance of 64Copper [64Cu]-SAR-bis-PSMA vs 68Ga PSMA-11 PET CT for the Detection of Prostate Cancer Recurrence in the Setting of Biochemical Failure Following Radical Prostatectomy (PHASE2)
- 64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA) (PHASE1, PHASE2)
- Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER) (PHASE1)
- 64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- 64Cu-SAR-bisPSMA CI brief — competitive landscape report
- 64Cu-SAR-bisPSMA updates RSS · CI watch RSS
- Clarity Pharmaceuticals Ltd portfolio CI
Frequently asked questions about 64Cu-SAR-bisPSMA
What is 64Cu-SAR-bisPSMA?
How does 64Cu-SAR-bisPSMA work?
What is 64Cu-SAR-bisPSMA used for?
Who makes 64Cu-SAR-bisPSMA?
What drug class is 64Cu-SAR-bisPSMA in?
What development phase is 64Cu-SAR-bisPSMA in?
What does 64Cu-SAR-bisPSMA target?
Related
- Drug class: All Radiopharmaceutical; PET imaging agent drugs
- Target: All drugs targeting PSMA (prostate-specific membrane antigen)
- Manufacturer: Clarity Pharmaceuticals Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for PET imaging of PSMA-positive prostate cancer
- Indication: Drugs for Detection and localization of metastatic prostate cancer lesions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing