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FDA Clears IND for Eilean Therapeutics’ Lomonitinib

Clearance from the FDA allows a Phase 1 clinical trial to be initiated in the U.S.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has cleared the IND for Eilean Therapeutics’ lomonitinib (ZE46-0134), allowing the company to proceed with a Phase 1 clinical trial in FLT3 mutated relapsed/refractory (R/R) AML.    While the Phase 1 study has already been initiated in Australia, clearance from the FDA will allow the trial to be initiated in the US.   Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative e...

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