RMC-035

RMC-035 is a first-in-class investigational biologic drug consisting of a recombinant and modified variant of the endogenous human protein alpha-1-microglobulin (A1M). It is designed to mimic and enhance the protective properties of natural A1M, with improved stability and solubility. RMC-035 acts as a renal protective agent by protecting cells and their mitochondria from injury caused by ischemia (restricted blood flow) and elevated levels of toxic heme. Its mechanism involves reducing oxidative stress and inflammation in the kidneys—key contributors to acute kidney injury (AKI), especially during cardiac surgery or kidney transplantation. The drug is administered intravenously over a short period in hospital settings for patients at high risk for AKI. RMC-035 has received Fast Track Designation from the FDA for reducing irreversible loss of kidney function after open-heart surgery in high-risk patients[1][6][8].

Brand names

ROSgard

Other names

alpha-1-microglobulin recombinant variantalpha1-microglobulin recombinant variantalpha 1-microglobulin recombinant variantrecombinant A1Msynthetic modified alpha-1-microglobulin