Clarity Pharmaceuticals has entered into a manufacturing agreement with Theragenics to support production of copper-64, as the company prepares for potential commercialization of its lead prostate cancer imaging agent.

The Sydney-based radiopharmaceutical company said the deal will utilize Theragenics’ facility near Atlanta, which operates 14 cyclotrons. The site is expected to contribute to supply of copper-64 for Clarity’s investigational product, 64Cu-SAR-bisPSMA, contingent on the outcome of Phase III trials and potential U.S. Food and Drug Administration approval.

Clarity is currently conducting two registrational studies, AMPLIFY and CLARIFY, evaluating the agent in prostate cancer imaging. The company has indicated that establishing manufacturing capacity is a priority as it approaches a possible market launch.
Theragenics, which has decades of experience producing medical radioisotopes, said its infrastructure supports high-volume output. According to Clarity, a single cyclotron at the facility can produce about 100 curies of copper-64 per day, which could equate to roughly 2,000 patient doses depending on dosing requirements.

The agreement expands Clarity’s existing U.S. manufacturing network, which includes arrangements with SpectronRx and Nusano. The company said this multi-site approach is intended to support future demand across oncology applications.

Copper-64 has a half-life of approximately 12.7 hours, longer than isotopes such as gallium-68. The extended half-life allows for a usable shelf life of up to two days, which may ease distribution and scheduling compared to shorter-lived tracers.

Mark Pugh, CEO of Theragenics, said the partnership reflects the company’s growing focus on isotope contract manufacturing. Alan Taylor, executive chairperson of Clarity, said the agreement is part of broader efforts to build supply capacity ahead of a potential commercial rollout.

64Cu-SAR-bisPSMA remains investigational and has not received regulatory approval.

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