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A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects With NERD After 6 Months

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Trial Profile

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects With NERD After 6 Months

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2024

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At a glance

  • Drugs Vonoprazan (Primary)
  • Indications Gastro-oesophageal reflux; Heartburn
  • Focus Registrational; Therapeutic Use
  • Acronyms PHALCON-NERD; PHALCON-NERD-301
  • Sponsors Phathom Pharmaceuticals

Most Recent Events

  • 07 Nov 2024 According to a Phathom Pharmaceuticals media release, an exploratory analysis from Phathom's Phase 3 Non-Erosive GERD study assessing the common yet infrequently evaluated nocturnal symptoms among Non-Erosive GERD patients, was presented in a poster presentation recognized with ACG's prestigious Presidential Poster Award, at the American College of Gastroenterology (ACG) 2024 Annual Meeting, held October 25-30 in Philadelphia, PA.
  • 08 Aug 2024 According to a Phathom Pharmaceuticals media release, R&D expenses for the second quarter 2024 were $7.4 million, a decrease of $5.4 million compared to $12.8 million for second quarter 2023. The decrease was a result of lower chemistry manufacturing and controls activity, decreased personnel costs, and lower clinical trial expenses due to the wrap-up of activities related to the Phase 3 PHALCON-NERD-301 daily dosing study.
  • 18 Jul 2024 According to a Phathom Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved VOQUEZNA (vonoprazan) 10 mg tablets for the relief of heartburn associated with Non-Erosive Gastroesophageal Reflux Disease (Non-Erosive GERD) in adults.

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