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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: 15 Jan 2025

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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

  • 08 Jan 2025 According to a Vanda Pharmaceuticals media release, Vanda issued a letter to FDA Commissioner Robert M. Califf, MD, regarding the September 18, 2024 CRL in reference to Vanda's NDA for tradipitant for the treatment of gastroparesis.
  • 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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