Phase III trial begins for CIPN prevention drug in Japan 

Asahi Kasei Pharma has commenced a Phase III clinical trial in Japan to evaluate ART-123 (thrombomodulin alfa; marketed in Japan as Recomodulin™) for the prevention of chemotherapy-induced peripheral neuropathy (CIPN).

The study builds on promising Phase I and II data and will assess safety and efficacy in patients with colorectal cancer receiving oxaliplatin-based chemotherapy. CIPN causes tingling and pain in the extremities, often forcing dose reductions or treatment suspensions. There are currently no approved therapies with established efficacy for CIPN prevention.

ART-123, a recombinant thrombomodulin first approved in Japan in 2008, may offer a much-needed option for patients and clinicians facing this debilitating side effect.

"Patients still have no proven options for preventing CIPN. We believe this study could lead to a much-needed breakthrough," said Yoshikazu Aoki, President of Asahi Kasei Pharma.

Asahi Kasei’s initiative aligns with its strategic focus on healthcare innovation under its current Medium-Term Management Plan.

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