Announcement of the commencement of a domestic Phase II clinical trial of "ADR-002K" for heart failure

Research and Development

Announcement of the commencement of a domestic Phase II clinical trial of "ADR-002K" for heart failure

April 25, 2025

ROHTO Pharmaceutical Co., Ltd. (Headquarters: Osaka; President and Representative Director: Masashi Sugimoto) is pleased to announce that it has initiated a domestic Phase II clinical trial (hereinafter referred to as "this trial") for the Regenerative medicine product "ADR-002K" for heart failure caused by ischemic heart disease.

Note

In recent years, the number of heart failure patients has been increasing with the progress of the aging society, and heart failure caused by ischemic heart disease *1 in particular is known to have a poor prognosis. It has been reported that patients with heart failure who have a reduced left ventricular ejection fraction (LVEF) *2 have a poor prognosis, making the development of new treatments an urgent need.
To address these medical needs, we have been developing "ADR-002K," which uses allogeneic adipose tissue-derived mesenchymal stem cells. Administration of this product at the time of coronary artery bypass surgery (CABG) is expected to further improve cardiac function and extend life expectancy. Safety has been confirmed in a Phase I trial conducted so far, and based on these results, this trial will evaluate the efficacy and safety of this product in patients with severe heart failure.
We will continue to develop innovative medical technologies, improve patients' quality of life, and contribute to medical care, thereby contributing to the health of people everywhere.

*1: A heart disease caused by narrowing or blockage of the coronary arteries that supply blood to the heart due to arteriosclerosis or other causes.
*2: An index showing how much blood the heart pumps with one contraction.