TOPNewsFiscal 2025Start of phase III study of ART-123 (Recomodulin™) in Japan for the prevention of sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)

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Start of phase III study of ART-123 (Recomodulin™) in Japan for the prevention of sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN)

June 27, 2025
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma announces that study drug administration has begun for the first patient in a phase III study of ART-123 in Japan (generic name: thrombomodulin alfa; marketed as Recomodulin™ Injection in Japan)1 for the prevention of sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN).

Chemotherapies such as platinum-based drugs, taxanes, and vinca alkaloids are known to induce peripheral neuropathy. If this condition known as CIPN, characterized by tingling and pain in the hands and feet, becomes severe, it not only impairs day-to-day activities but may also lead to a clinical effect on the patient’s prognosis due to reduced dosage or suspension of chemotherapy administration. However, there are currently no drugs showing clear established effectiveness for the prevention or treatment of CIPN.

Previously performed phase I and II studies suggest efficacy and tolerability of ART-123 for CIPN.2 Based on the results of those studies, a decision to perform the phase III study was made as a result of discussions with the regulatory authorities regarding future prospects for clinical development. The phase III study will assess the efficacy of ART-123 for CIPN in patients diagnosed with colorectal cancer and undergoing chemotherapy including the platinum drug oxaliplatin.

By providing a new drug that contributes to improved quality of life for patients with CIPN, Asahi Kasei Pharma aims to realize a society where “no one should have to give up doing what they love due to illness” in accordance with its mission “to sincerely care for each individual life and solve their unmet medical needs with a wealth of ideas and solid science.”

  • 1A recombinant human thrombomodulin approved in Japan since 2008 for the treatment of disseminated intravascular coagulation (DIC), ART-123 is thought to suppress CIPN through the activation of protein C and thrombin activatable fibrinolysis inhibitor (TAFI)
  • 2Kotaka, M., Saito, Y., Kato, T. et al. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol 86, 607–618 (2020).

Click here for more information about the study
https://jrct.mhlw.go.jp/en-latest-detail/jRCT2051250045