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FDA grants orphan drug designation to darizmetinib for the prevention of post-hepatectomy liver failure
On August 10, 2026, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to darizmetinib, a selective inhibitor of mitogen-activated protein kinase kinase 4 (MKK4), for the prevention of post-hepatectomy liver failure in patients undergoing liver resection.1
The designation follows completion of the initial part of a phase Ib/IIa study (NCT06638502) evaluating darizmetinib in patients undergoing minor liver resection for colorectal cancer liver metastases.2 The second part of the study is expected to commence in the third quarter of 2026 and will evaluate the safety and pharmacokinetics of darizmetinib in patients undergoing major liver resection.2
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