Phathom Pharmaceuticals Launches Phase 3 Trial for As-Needed GERD Treatment
Event summary
- Phathom Pharmaceuticals initiated a Phase 3 trial (pHalcon-NERD-302) for VOQUEZNA® (vonoprazan) as an as-needed treatment for Non-Erosive GERD (NERD).
- The study aims to enroll approximately 500 adults with NERD across 80 U.S. sites, with topline results expected in Q1 2028.
- If successful, the trial could support a label expansion for VOQUEZNA, allowing its use for on-demand heartburn relief in NERD patients.
- VOQUEZNA is currently approved for Erosive GERD, Non-Erosive GERD heartburn relief, and H. pylori infection treatment.
The big picture
Phathom Pharmaceuticals is exploring a new treatment paradigm for Non-Erosive GERD, a condition affecting millions of U.S. patients. The shift from continuous daily therapy to as-needed use could address unmet needs and differentiate VOQUEZNA in a crowded market. Success in this trial would expand Phathom's commercial opportunities beyond its current approved indications.
What we're watching
- Regulatory Pathway
- Whether the Phase 3 trial results will be sufficient to secure FDA approval for the as-needed use of VOQUEZNA in NERD patients.
- Market Opportunity
- The potential impact of an as-needed treatment option on the competitive landscape for GERD therapies.
- Execution Risk
- The pace at which Phathom can enroll patients and generate topline data, given the study's scale and complexity.