---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-265692"
form_type: "8-K"
ticker: "PHAT"
cik: "0001783183"
company_name: "Phathom Pharmaceuticals, Inc."
filed_at: "2023-10-30T23:59:59+00:00"
generated_at: "2026-06-09T06:09:21.894873+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA approves reformulated vonoprazan for H. pylori; launch expected Dec 2023

## Summary
- FDA approved prior approval supplements for reformulated vonoprazan tablets in VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for H. pylori infection in adults.
- Product expected to be available in the U.S. in December 2023 and marketed exclusively by Phathom.
- H. pylori infects an estimated 115 million individuals in the U.S.; 36% of the U.S. population estimated to be infected.
- Phathom planning combined U.S. commercial launch of H. pylori regimens and Erosive GERD vonoprazan, if approved.

## SEC filing metadata
- accession: 0001193125-23-265692
- form_type: 8-K
- ticker: PHAT
- cik: 0001783183
- company_name: Phathom Pharmaceuticals, Inc.
- filed_at: 2023-10-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1783183/000119312523265692/0001193125-23-265692-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1783183/000119312523265692/d491934d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-265692
- JSON: https://secwatch.observer/filing/0001193125-23-265692.json
- Plain text: https://secwatch.observer/filing/0001193125-23-265692.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.