Epetraborole - (EBO-PV-201)

November 2, 2026: AN2 Therapeutics (NASDAQ: ANTX) announced FDA clearance of its Investigational New Drug application for epetraborole in polycythemia vera (PV), giving the company regulatory clearance in all planned jurisdictions for the global study (U.S., Australia, and India). AN2 said it expects to initiate the Phase 2 trial in Q4 2026.

The planned Phase 2 study in phlebotomy-dependent adults with PV will begin with an open-label sentinel cohort and an open-label dose-optimization cohort for dose selection (Part 1), followed by a randomized, double-blind, placebo-controlled cohort (Part 2) and an optional open-label extension (Part 3). The study is designed to assess efficacy on key hematologic variables, optimize dosing on an individual-patient basis, and evaluate safety, tolerability, and patient-reported outcomes.

The company said preclinical and human data generated to date support epetraborole’s potential to provide early, controlled, sustained, and dose-dependent control of hematocrit, but no clinical efficacy results from the PV program were reported in this release.