Japan grants conditional approval to ReHeart, first iPSC-derived therapy for heart failure

Cuorips/ReHeart

Japan's Ministry of Health, Labour and Welfare granted conditional and time-limited approval for ReHeart, a 4–5 cm diameter, 0.1 mm thick cardiac patch of iPSC-derived cardiomyocytes. Alongside Sumitomo Pharma's Amchepry for Parkinson's, these mark the world's first practical use of iPSC-derived medical products in clinical practice.

• First iPSC-derived therapy approved for heart disease; Amchepry is first overall for Parkinson's
• Market launch planned around autumn 2026 following insurance coverage approval
• Conditional approval requires continued verification of efficacy and seven-year follow-up data collection on 75 patients
• Drug price set at 53.2 million yen; first transplant case scheduled for September–October 2026