On November 2, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics derived from its boron chemistry platform, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for epetraborole in polycythemia vera (PV). The Company has now received regulatory clearance in all planned jurisdictions (Australia, India, and the U.S.) for the global study and expects to initiate the trial in the fourth quarter of 2026.
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"We’re pleased to receive FDA IND clearance and the necessary authorizations globally to advance epetraborole into Phase 2 clinical development for polycythemia vera," said Cameron Trenor, M.D., Chief Medical Officer of AN2 Therapeutics. "Extensive preclinical and human data generated to date indicate that epetraborole has the potential to produce early, controlled, sustained and dose-dependent control of hematocrit, providing a strong rationale for clinical development in PV. We anticipate initiating the Phase 2 trial in the fourth quarter of 2026."
About the Phase 2 Study of Oral Epetraborole in PV
The planned Phase 2 study consists of an open-label epetraborole sentinel cohort, an open-label dose optimization cohort for dose selection (Part 1), followed by a double-blind, randomized, placebo-controlled cohort (Part 2), and an optional open-label extension cohort (Part 3). The study is designed to assess the efficacy of oral epetraborole in phlebotomy-dependent adults with PV and its effect on key hematological variables, to optimize a dose regimen on a by-patient level, to assess safety and tolerability, and and to assess patient-reported outcomes (PROs) using validated PRO instruments.
About Polycythemia Vera (PV)
PV is a blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit which can lead to serious medical complications, including arterial and venous thromboembolic events. If untreated, PV can be life-threatening. Despite available therapies, many patients experience uncontrolled hematocrit levels and persistent symptom burden, requiring long term management to maintain adequate disease control. PV is estimated to affect approximately 155,000 people in the U.S.
(Press release, AN2 Therapeutics, NOV 2, 2026, View Source [SID1234674060])