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AN2 wins FDA IND clearance for Phase II epetraborole study in polycythemia vera
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Fusion42 · 5 November 2026 · Fusion42 review
AN2 Therapeutics received FDA IND clearance for a Phase II global study of epetraborole in polycythemia vera, with trial sites planned in the US, Australia, and India, aiming to begin in Q4 2026. This regulatory clearance completes authorization for AN2's study across three major markets, enabling the company to initiate a multi-part clinical trial to evaluate the drug's efficacy and safety in controlling hematocrit levels in PV patients.
This Wire brief sits within Fusion42's coverage of Biotech.
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You can now plan trial activities and partnerships in the US with FDA IND approval secured; time to focus on patient recruitment logistics before the Q4 2026 start date. This clearance opens the door specifically for oral epetraborole in polycythemia vera, creating a window to build early clinical momentum against newer therapies.
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1 source · 4 Nov 2026
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