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OKI-355

Development stage: Preclinical
Lead developer: OnKure Therapeutics
Modality: Small Molecules

Overview

OKI-355 is a next-generation, small molecule PI3Kα pan-mutant selective inhibitor being developed by OnKure Therapeutics. It is designed to selectively inhibit mutant forms of PI3Kα while sparing the wildtype protein, potentially offering a wider therapeutic index and avoiding class-limiting toxicities such as hyperglycemia. PI3Kα mutations are common driver alterations in vascular anomalies, where they lead to dysregulated signaling and abnormal cell growth. OnKure plans to submit an Investigational New Drug (IND) application for OKI-355 in the first half of 2027 for the treatment of vascular anomalies.

Targets

PIK3CA (Phosphoinositide 3-kinase alpha)

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