Nuclidium Receives Patent for Radiodiagnostic Program for PSMA-positive Prostate Cancer

Jan. 26, 2026 — Nuclidium, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, recently announced that U.S. Patent No. 12,527,885 has been granted by the United States Patent and Trademark Office (USPTO). This strengthens and extends the scope of the intellectual property portfolio for Nuclidium’s NU101 radiotheranostic program. The patent protects the Copper-61 based diagnostic as well as its use in combination with the Copper-67 based therapeutic in a theranostic setting. Nuclidiums NU101 theranostic program was designed to use high-radiopure Copper-61 to diagnose and Copper-67 to treat Prostate-Specific Membrane Antigen (PSMA)-positive tumors, making it a true theranostic by using the same radiometal.

“This patent grant validates the scientific innovation behind our copper-based radiopharmaceutical platform and strengthens our ability to advance differentiated therapies across our pipeline. Robust intellectual property is critical as we accelerate the clinical development of our best-in-class copper-based radiotheranostic programs and strive to deliver new treatment options for patients with difficult-to-treat cancers, including prostate and metastatic breast cancer,” said Leila Jaafar, PhD, CEO and Co-Founder of Nuclidium.

The issued patent covers the composition of matter and methods of using the radiodiagnostic ⁶¹Cu-NU101 in radioimaging, including Positron Emission Tomography (PET) and Single Photon Emission Computed Tomography (SPECT) imaging of PSMA-positive tumors, as well as the subsequent combination with the therapeutic pair ⁶⁷Cu-NU101. Over 90% of prostate tumors express PSMA¹, rendering this surface-level antigen an attractive target for cancer diagnosis and treatment. Nuclidium’s ⁶¹Cu-based NU101 diagnostic component allows for delayed imaging, in which even very small metastases can be detected. Based on these imaging data, the ⁶⁷Cu-based NU101 therapeutic can enable targeted treatment with a potentially reduced radiation burden for the patient.

The diagnostic component ⁶¹Cu-NU101 is currently in clinical evaluation. Data from a Phase 1 trial showed favorable imaging performance for ⁶¹Cu-NU101 in PSMA-positive prostate cancer compared with an FDA-approved standard of care diagnostic imaging agent. ⁶¹Cu-NU101 visualized additional lesions in 50% of the patients which were not seen with the FDA-approved standard of care agent and demonstrated favorable tumor-to-background ratios. The number of detected lesions on the ⁶¹Cu-NU101 PET increased for up to 4 hours after administration, highlighting the diagnostic benefits of ⁶¹Cu-NU101’s 3.3-hour half-life and high positron yield. Based on these favorable data, Nuclidium is planning to initiate Phase 2 clinical trials for the NU101 diagnostic and therapeutic pair in 2026.

1. Calais J, Czernin J. PSMA Expression Assessed by PET Imaging Is a Required Biomarker for Selecting Patients for Any PSMA-Targeted Therapy. J Nucl Med. 2021 Nov;62(11):1489-1491. doi: 10.2967/jnumed.121.263159. PMID: 34725231; PMCID: PMC8612346.