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A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2024

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At a glance

  • Drugs Vonoprazan (Primary) ; Lansoprazole
  • Indications Erosive oesophagitis; Heartburn
  • Focus Registrational; Therapeutic Use
  • Acronyms PHALCON-EE
  • Sponsors Phathom Pharmaceuticals

Most Recent Events

  • 21 Aug 2023 According to a Phathom Pharmaceuticals media release, the company has submitted to the FDA six-month stability data from its long-term and accelerated stability program for its reformulated vonoprazan tablets.
  • 12 Jun 2023 According to a Phathom Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has acknowledged New Drug Application (NDA) resubmission for vonoprazan. The FDA has classified this as a Class 2 resubmission and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 17, 2023.
  • 23 May 2023 According to a Phathom Pharmaceuticals media release, the company anticipates the potential approval later this year.

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