Phathom Pharmaceuticals Initiated GERD Study

The company has launched a Phase 3 trial to evaluate the use of VOQUEZNA for non-erosive heartburn.

Updated on Sept. 29, 2026 in Diseases — General

Phathom Pharmaceuticals Initiated GERD Study

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Phathom Pharmaceuticals has begun patient screening for its pHalcon-NERD-302 Phase 3 study. This trial evaluates the 10 mg VOQUEZNA dose as an as-needed treatment for patients with non-erosive gastroesophageal reflux disease (NERD).

Why it matters

The study aims to support a potential label expansion for VOQUEZNA, addressing the demand from patients and physicians for an as-needed medication option for NERD. Currently, approximately 15 million Americans are estimated to be affected by the non-erosive form of the condition.

The study will enroll 500 adults who report heartburn at least four days per week and follow a 24-week treatment period. Patients receive 10 mg of VOQUEZNA compared against a placebo group after an initial four-week run-in phase.

The players

Phathom Pharmaceuticals

This biopharmaceutical company is based in Florham Park, N.J., and focuses on developing treatments for gastrointestinal diseases.

The details

Patients undergo a four-week open-label run-in period with daily 10 mg doses of VOQUEZNA to monitor symptoms before randomization. Those who report no heartburn during the final seven days of this run-in period are then randomized 1:1 to receive either the medication or a placebo.

Patient screening for the study was initiated on September 29, 2026.
Topline results from the Phase 3 trial are expected in the first quarter of 2028.

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Health Landscape

This trial represents a shift in standard GERD care by targeting as-needed relief for non-erosive cases rather than chronic maintenance therapy. It follows the regulatory protocols for label expansion documented in the clinical trials registry search.

This study could eventually provide patients with a new, as-needed option for managing non-erosive heartburn symptoms. Participants and their doctors must currently rely on existing treatments until the trial results are validated and regulatory approval is granted.

The takeaway

This trial addresses the specific clinical need for flexible medication use in the millions of Americans managing non-erosive reflux disease. As the trial progresses, patients should continue to consult their gastroenterologists regarding currently approved management strategies.