Japan Approves World’s 1st iPS Cell-based Treatment; May Be Available as Early as Summer

The Yomiuri Shimbun

14:14 JST, March 6, 2026

Two regenerative medicine products made from induced pluripotent stem cells have been conditionally approved, the Health, Labor and Welfare Ministry announced Friday. The approval comes with certain conditions and time limits.

This opens the door to the world’s first commercialized treatment using iPS cells. Following national deliberations, a decision will be made on the price and whether it will be covered by public health insurance. The treatment could be available as early as this summer.

iPS cells can transform into various cell types and are created by introducing several genes into cells, such as those from the skin or blood.

Cuorips Inc., a startup out of the University of Osaka, has created a product called “RiHEART” that targets severe heart failure caused by ischemic cardiomyopathy. Cardiomyocytes made from iPS cells are processed into sheets. Three sheets are attached to the heart to promote blood vessel regeneration and restore cardiac function. Sales are expected to begin around this autumn.

Amchepry, a product from Sumitomo Pharma Co., targets Parkinson’s disease. Transplanted nerve cells made from iPS cells into the patient’s brain produce dopamine, which is expected to improve motor disorders such as tremors in the limbs and difficulty in walking. The company aims to start selling the product between summer and autumn this year.