Patient Screening Initiated in Phase 3 pHalcon-NERD-302 Study of As-Needed VOQUEZNA for Non-Erosive Gastroesophageal Reflux Disease – Phathom Pharmaceuticals

Written by Charlie King | 3 Oct 2026 | Gastroenterology

Phathom Pharmaceuticals, Inc. announced the initiation of patient screening 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, or Non-Erosive GERD (NERD). Topline results are expected in the first quarter of 2028.

If successful, the study is intended to support a potential regulatory submission seeking a label expansion for Voquezna tablets for this treatment regimen.

“With pHalcon-NERD-302, we are studying what we believe could be an important new treatment approach for patients with Non-Erosive GERD. The study is designed to assess whether as-needed Voquezna can provide rapid relief of heartburn when symptoms occur, with relief sustained over 24 hours. We have heard from many physicians and patients about the desire for an as-needed option. If successful, this study could support a potential label expansion for Voquezna and an important opportunity to potentially broaden how Voquezna may be used in the future to meet the needs of patients with Non-Erosive GERD.” – Steve Basta, President and Chief Executive Officer of Phathom Pharmaceuticals.

Voquezna Phase 3 As-Needed Program

Building on previously reported positive Phase 2 results, pHalcon-NERD-302 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. The Phase 3 pHalcon-NERD-302 study is expected to enroll approximately 500 adults with Non-Erosive GERD who report heartburn at least four days per week. The study is planned to be conducted at approximately 80 sites in the U.S. 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. 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.

“Non-Erosive GERD is characterized by episodic, often unpredictable heartburn. Proton-pump inhibitor acid-suppressing therapies generally rely on continuous daily use. An as-needed treatment approach would need to provide acid suppression that starts rapidly and is sustained long enough to control heartburn over 24 hours. The results from the earlier Phase 2 as-needed study of Voquezna provide a strong rationale for evaluating its efficacy and safety in this Phase 3 trial.” – Ronnie Fass, M.D., Division Director of Gastroenterology and Hepatology and Medical Director of the Digestive Health Center at MetroHealth Medical Center, Professor of Medicine at Case Western Reserve University School of Medicine, and an investigator for pHalcon-NERD-302.

“One of the practical questions in managing Non-Erosive GERD is whether patients with intermittent symptoms need continuous daily therapy. This registrational study is designed to evaluate whether an as-needed treatment approach can provide effective heartburn relief when symptoms occur.” – Philip O. Katz, M.D., Professor of Medicine in the Division of Gastroenterology and Hepatology at Weill Cornell Medicine, gastroenterologist at NewYork-Presbyterian/Weill Cornell Medical Center, and an investigator for pHalcon-NERD-302. Dr. Katz serves as a consultant for Phathom Pharmaceuticals.

For more information about the pHalcon-NERD-302 study (NCT07752407), visit ClinicalTrials.gov.