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OZTx-556 (also known as iCM) is an investigational regenerative cell therapy consisting of highly purified induced pluripotent stem cell (iPSC)-derived cardiomyocytes. Developed by Orizuru Therapeutics through the T-CiRA collaboration between Kyoto University's Center for iPS Cell Research and Application (CiRA) and Takeda Pharmaceutical, it is designed for the treatment of severe chronic heart failure. The therapy works by transplanting these cardiomyocytes into the patient's heart to replenish lost cardiac cells and promote cardiac remuscularization, thereby restoring contractile function. The product is manufactured using a proprietary differentiation method and is designed for minimally invasive catheter administration. Preclinical studies in animal models, including rats and monkeys, have demonstrated significant improvements in left ventricular ejection fraction and stable long-term engraftment.
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