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VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

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Trial Profile

VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2023

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At a glance

  • Drugs Tradipitant (Primary)
  • Indications Gastroparesis
  • Focus Expanded access; Therapeutic Use
  • Acronyms VP-VLY-686-3303
  • 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).
    • 03 May 2023 According to a Vanda Pharmaceuticals media release, the company expects to submit NDA to the FDA in the second quarter of 2023.
    • 04 Feb 2022 According to a Vanda Pharmaceuticals media release, company intends to schedule a conference call to discuss the results from this study.
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