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FDA approves once-daily, extended-release tablet formulation of ruxolitinib for MF and PV
On May 1, 2026, the U.S. Food and Drug Administration (FDA) approved a once-daily (QD), extended-release tablet formulation of ruxolitinib for adults with intermediate- or high-risk myelofibrosis (MF) and adults with polycythemia vera (PV) following inadequate response or intolerance to hydroxyurea.
The approval was based on findings from a phase I clinical trial (NCT06555081) evaluating the bioequivalence of ruxolitinib extended-release (XR) tablets vs ruxolitinib immediate-release (IR) tablets in healthy adults.2 A single 55 mg XR tablet administered QD was shown to be bioequivalent to a single 25 mg IR tablet administered twice daily (BD), with steady-state exposure supporting comparable 24-hour ruxolitinib exposure.2 Safety for this approval was established in previous studies of ruxolitinib in adults with MF and PV.1 The most common adverse reactions reported in patients with MF and PV included thrombocytopenia, anemia, bruising, dizziness, headache, and diarrhea.1
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