Phathom begins screening in Phase 3 study of as-needed VOQUEZNA for Non-Erosive GERD

Phathom Pharmaceuticals announced on September 29, 2026 that patient screening has begun in pHalcon-NERD-302, a registrational Phase 3 study evaluating an as-needed (PRN or on-demand) investigational dosing regimen of VOQUEZNA (vonoprazan) tablets in adults with Non-Erosive Gastroesophageal Reflux Disease (NERD).¹

Topline results are expected in the first quarter of 2028.¹ If the study succeeds, it is intended to support a potential regulatory submission seeking a label expansion for VOQUEZNA tablets for this treatment regimen.¹

The trial builds on earlier data. pHalcon-NERD-302 follows previously reported positive Phase 2 results, and is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study investigating VOQUEZNA 10 mg as an as-needed treatment in adults with Non-Erosive GERD.¹ The study is expected to enroll approximately 500 adults with Non-Erosive GERD who report heartburn at least four days per week.¹ It is planned to be conducted at approximately 80 sites in the U.S.¹

The design includes a run-in phase before randomization. Following a four-week, open-label run-in period with VOQUEZNA 10 mg once daily, patients without heartburn during the final seven days of the run-in period will be randomized 1:1 to receive VOQUEZNA 10 mg or placebo, as-needed, for 24 weeks of treatment.¹

The study's primary endpoint is defined at an early timepoint. The primary endpoint, assessed at Week 12, is the percentage of heartburn episodes in which patients experience complete relief within two hours and sustained relief for 24 hours post-dosing.¹