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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Dec 2023

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At a glance

  • Drugs Tradipitant (Primary)
  • Indications Gastroparesis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Vanda Pharmaceuticals

    • Most Recent Events

    • 04 Dec 2023 According to a Vanda Pharmaceuticals media release, based on results from 2301, 3301 and Expanded Access program, the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis. The FDA has set September 18, 2024 date under Prescription Drug User Fee Act (PDUFA).
    • 17 Oct 2023 Results of pooled analysis from VP-VLY-686-3301 and VP-VLY-686-2301 assessing the efficacy of tradipitant in relieving symptoms of gastroparesis presented at the 31st United European Gastroenterology Week
    • 09 May 2023 Pooled data (n=342 ) from VP-VLY-686-3301 and VP-VLY-686-2301 are, presented at the Digestive Disease Week 2023.
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