OVI-117

OVI-117 is an investigational L-nucleoside conjugate and derivative of FdUMP/5-fluorouracil designed as a potent inhibitor of thymidylate synthase (TYMS) with improved pharmacologic properties, aiming to retain the antitumor efficacy of fluoropyrimidines while reducing systemic toxicity.[1][2][5][7][9] Developed originally by Lipitek International and later licensed to OncoVista Innovative Therapies, the agent has been pursued primarily for solid tumors, including colon, breast, gastric, and prostate cancers, with preclinical data indicating in vivo activity in colon, breast, and prostate cancer models and reduced toxicity relative to standard therapy.[1][2][3][5][6][7][10][11] The FDA approved an IND application for a Phase I trial of OVI-117 in solid tumors, but the program did not advance to approval and has since been discontinued, with OncoVista’s license rights reverting to Lipitek after OncoVista became dormant.[2][5][7][10][11]