Abbisko Therapeutics’ Oral Small Molecule KRAS G12D Inhibitor Approved for Clinical Trials in the US

December 3, 2025  Source: drugdu 50

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Abbisko Therapeutics announced that its investigational oral, highly active, highly selective small molecule KRAS G12D inhibitor, ABSK141, has received approval from the US Food and Drug Administration (FDA) for an Investigational New Drug (IND) application to treat patients with advanced solid tumors harboring the KRAS G12D mutation.
Commentary: The announcement by Abbisko Therapeutics that its oral KRAS G12D inhibitor ABSK141 has received FDA IND approval is a critical R&D advancement. This drug targets the KRAS G12D mutation, for which there are currently no approved targeted therapies. This mutation is one of the most common oncogenic mutations in various solid tumors, including pancreatic and colorectal cancers, highlighting a pressing clinical need.

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