News

KYORIN Pharmaceutical Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo, President andCEO: Yutaka Ogihara, "KYORIN") and SUSMED Inc. (Headquarters: Chuo-ku, Tokyo, President and CEO: Taro Ueno, "SUSMED") announced today the initiation of aconfirmatory study for KRP-DT123/SMD403, a digital therapeutic designed for the treatment of tinnitus.
KRP-DT123/SMD403 is a digital therapeutic (medical device program) aiming for healthinsurance coverage, which is being jointly developed by KYORIN and SUSMED.
This confirmatory study (pivotal study) is a multicenter, randomized, double-blind,controlled trial to evaluate the efficacy and safety of using this application for 16 weeks in patients with distressing chronic tinnitus. Following the completion of the trial, KYORIN plans to submit an application for manufacturing and marketing approval in Japan.
Currently, there are no approved digital therapeutics specifically targeting tinnitus.
KYORIN and SUSMED are conducting the development by leveraging KYORIN's knowledge in disease areas and clinical development, along with SUSMED's digital therapeutics development platform, clinical trial management system (SUSMEDSourceDataSync®), and its know-how.
By developing and commercializing this application, we aim to provide a new treatment option for patients suffering from tinnitus.