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FDA approval
Clarity Pharmaceuticals receives FDA Fast Track designation for 64Cu-SAR-bisPSMA candidate for prostate cancer diagnosis
Precision Medicine
Aug 22, 2024
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Precision Medicine

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Aug 22, 2024

Clarity Pharmaceuticals receives FDA Fast Track designation for 64Cu-SAR-bisPSMA candidate for prostate cancer diagnosis

FDA approval

  • Clarity Pharmaceuticals has received the Fast Track designation by the US FDA for its 64Cu-SAR-bisPSMA candidate for PET imaging in diagnosing prostate cancer. This drug is planned to detect metastasis in patients who are potential candidates for initial definitive therapy.

  • The drug is currently being tested in its registrational Phase III trial, CLARIFY, and Phase I/II trial, COBRA, for two different indications relating to prostate cancer treatment. In previous studies, the drug is claimed to be safe and effective in detecting prostate cancer in patients. It also reportedly has a longer half-life and can identify smaller lesions compared to gallium-68 and fluorine-18-based diagnostics.

  • Clarity Pharmaceuticals is a clinical-stage radiopharmaceutical company focused on developing next-generation oncology treatments. It leverages its proprietary Targeted Copper Theranostic (TCT) platform, which uses copper isotopes for diagnostic imaging and therapy. Clarity's lead product, SAR-bisPSMA, is being developed for prostate cancer diagnosis and treatment. Its product pipeline also includes SAR-Bombesin and SARTATE for various cancer indications.

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