SH-201

SH-201 is a palatable oral liquid formulation of a chemotherapeutic agent developed for the treatment of certain leukemias and cancers, including chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), and gastrointestinal tumors. It is notable as the first palatable oral liquid version of its class in the United States, designed to address unmet needs for patients who require or prefer an oral solution over traditional formulations. The drug works by slowing or stopping the growth of malignant cells in these diseases. The specific active ingredient and detailed mechanism of action have not been publicly disclosed as of June 2025, but it is classified as a small molecule chemotherapeutic agent. SH-201 was developed by Shorla Oncology, which has submitted a New Drug Application to the FDA; a regulatory decision is expected by November 30, 2024[1][2][3][7].