JBI-802 Receives FDA Orphan Drug Status For AML

By Leah Sherwood - Last Updated: January 23, 2023

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for JBI-802 for the treatment of acute myeloid leukemia (AML).

The drug was also granted Orphan Drug Designation for the treatment of small cell lung cancer.

JBI-802, a novel, oral, potent, and selective dual inhibitor of lysine specific demethylase 1 (LSD1) and histone deacetylase 6 (HDAC6), is currently being investigated in a phase I/II trial in patients with advanced solid tumors. The manufacturer of the drug reported that the goal is to investigate the drug’s activity in hematologic malignancies such as AML, essential thrombocythemia, and other myeloproliferative neoplasms.

Source: Jubilant Therapeutics, January 2023

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