Phathom Pharmaceuticals Announces Initiation of Registrational Phase 3 Study of VOQUEZNA® (vonoprazan) for As-Needed Treatment of Non-Erosive GERD
Phathom Pharmaceuticals initiated patient screening in pHalcon-NERD-302, a registrational Phase 3 study of as-needed VOQUEZNA (vonoprazan) 10 mg in adults with Non-Erosive GERD, with topline results expected in Q1 2028. The trial plans to enroll approximately 500 adults across roughly 80 U.S. sites, testing whether PRN dosing provides rapid, sustained heartburn relief versus placebo, building on positive Phase 2 results. A successful readout could support a label expansion for as-needed use in NERD, a regimen not currently approved for PPIs in the U.S., potentially broadening VOQUEZNA's addressable population of an estimated 15 million U.S.
Key figures
- Drug Name
- VOQUEZNA (vonoprazan)
- Phase Of Trial
- Phase 3
- Trial id
- NCT07752407
- Study sites
- approximately 80 U.S. sites
- Dosing regimen
- as-needed (PRN) VOQUEZNA 10 mg
- Expected enrollment
- 500
- Topline results timing
- first quarter of 2028
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.