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# Phathom Pharma Files NDA for Heartburn
- URL: https://www.fdaweb.com/phathom-pharma-files-nda-for-heartburn/
- Published: 2023-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:18:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155959

FDA has accepted for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adults. The agency has set a user fee review action target date of 7/19/2024.

The submission is based on data from the PHALCON-NERD-301 trial. Phathom says it is also planning to initiate an additional Phase 3 study (XXX DELETE XXX)evaluating the drug as an as needed treatment for episodic heartburn relief in adults with non-erosive GERD.

Voquezna is a potassium-competitive acid blocker that is currently approved for treating adults with all grades of GERD and providing relief of heartburn associated with erosive GERD.