KSHN001022

KSHN001022 is an orally bioavailable prodrug of fulvestrant, a selective estrogen receptor degrader (SERD). Developed by Kashiv BioSciences (which was acquired by Amneal Pharmaceuticals in 2026), KSHN001022 was designed to overcome the poor pharmacokinetic profile, low solubility, and weak permeation of intramuscularly administered fulvestrant. By appending structurally diverse pro-moieties to fulvestrant, the prodrug significantly enhances solubility and permeability, enabling oral delivery. In preclinical MCF-7 xenograft models of estrogen-dependent breast cancer, KSHN001022 demonstrated robust antitumor activity and tumor volume regression.