The U.S. Food and Drug Administration (FDA) has granted Clarity Pharmaceuticals fast-track designation for its copper-64 (Cu-64) sarcophagine (SAR) bisPSMA radiopharmaceutical.
The company is investigating the potential of Cu-64 SAR-bisPSMA for PET imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions for men with suspected metastasis who are candidates for initial definitive therapy.
Clarity's ongoing clinical program with Cu-64 SAR-bisPSMA includes trials in two indications: prostate cancer patients prior to undergoing radical prostatectomy, and with biochemical recurrence of their disease.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
