Protagonist Therapeutics’ Rusfertide Study: A Promising Update for Polycythemia Vera Treatment

Protagonist Therapeutics Inc ((PTGX)) announced an update on their ongoing clinical study.

Protagonist Therapeutics Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera.’ The study aims to evaluate the safety and efficacy of rusfertide in maintaining hematocrit control and improving symptoms in patients with polycythemia vera (PV), a condition characterized by an overproduction of red blood cells.

The intervention being tested is rusfertide, an experimental drug designed to mimic hepcidin, which is intended to help manage PV symptoms and reduce the need for routine phlebotomy in patients.

The study employs a randomized, double-blind, parallel intervention model with triple masking involving participants, investigators, and outcomes assessors. Its primary purpose is treatment, with an initial 32-week phase where participants receive either rusfertide or a placebo, followed by a 124-week open-label phase where all participants receive rusfertide.

The study began on April 1, 2022, and is currently active but not recruiting. The primary completion date is not specified, but the last update was submitted on August 4, 2025, indicating ongoing progress and data collection.

This clinical update could positively impact Protagonist Therapeutics’ stock performance and investor sentiment, as successful results may position rusfertide as a leading treatment option for PV. The competitive landscape includes other treatments like hydroxyurea and ruxolitinib, but rusfertide’s unique mechanism could offer a distinct advantage.

The study is ongoing, with further details available on the ClinicalTrials portal.