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REG101 is a proprietary recombinant protein therapeutic developed by Regencor, a regenerative medicine company founded as a spin-out from Stanford University. The drug consists of a hypoglycosylated (unglycosylated) variant of follistatin-like 1 (FSTL1), a naturally occurring human protein that, in its unglycosylated form, exhibits potent regenerative properties. REG101 is designed to treat acute myocardial infarction and chronic heart failure by stimulating the proliferation of cardiomyocytes (heart muscle cells) following cardiac injury. This mechanism aims to reverse scar tissue formation, restore cardiac function, and prevent the progression to heart failure. REG101 is administered subcutaneously and has shown efficacy in large animal models; it is currently undergoing IND-enabling studies with human clinical trials anticipated to begin in late 2025.
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