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# Phathom NDA for Erosive Esophagitis NDA Accepted
- URL: https://www.fdaweb.com/phathom-nda-for-erosive-esophagitis-nda-accepted/
- Published: 2022-05-25T12:00:00.000Z
- Updated: 2026-09-14T17:46:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151895

FDA has accepted for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive esophagitis and relief of heartburn, as well as the maintenance of healing and relief of these conditions. Vonoprazan is described as a novel, orally administered investigational potassium-competitive acid blocker from a new class of acid suppressant agents. The agency has set a user fee review action target date of 1/11/2023.  
  
The submission is based on data from the company’s [previously announced](https://www.globenewswire.com/Tracker?data=7EKSn4BSpoKci36MnyksiaP24QtK5hOykll1TN5U12Qc9qnePtC0jhJJvh8FYVo4t8sEgc4y5dgkLLfMTU78H4d1wURrExs4TzuA6L3tY0UEFS7Iwv3-WTxyxIWPanzrwl4jOOHSV2lGZUhxyIogG1X3zN6CCCMEGpJUztMnWcGIqM224A38AVxqL7wdrX8p6gyStca66qxmO%5FiWve3z2-TCSyLPX%5FUvVyg%5FmYISzrg=&ref=fdaweb.com) pivotal PHALCON-EE Phase 3 trial. The company says PHALCON-EE successfully met its primary endpoints and key secondary superiority endpoints.