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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: 31 Jan 2025

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At a glance

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

Most Recent Events

  • 27 Jan 2025 According to Vanda Pharmaceuticals media release, the FDA discounted the pooled analysis of 2 studies [Study 1 (NCT02970968) & Study 2 (NCT04028492)] that showed extended significance of Tradipitant efficacy beyond that in this study (Study 1). Vanda disagreed and requested copies of the FDA reviews under Freedom of Information Act (FOIA). The FDA published those conclusions in the Federal Register, and gave a Notice of Opportunity for Hearing (NOOH) to Vanda, which the company has accepted.
  • 18 Sep 2024 According to a Vanda Pharmaceuticals media release, the US FDA declined to approve Vanda New Drug Application (NDA) of for the treatment of symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL).
  • 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).

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