Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis

Next Previous
Trial Profile

VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Jan 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Tradipitant (Primary)
  • Indications Diabetic gastroparesis; Gastroparesis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vanda Pharmaceuticals

Most Recent Events

  • 27 Jan 2025 According to a Vanda Pharmaceuticals media release, the FDA discounted the efficacy evidence from a 600-patient open label study, which is an open-label extension to this study, where tradipitant showed statistically significant improvements from baseline.
  • 27 Jan 2025 According to a Vanda Pharmaceuticals media release, the FDA had disagreed with the validity and interpretation of additional exploratory analyses for study 2 (this study). Vanda did not agree with this conclusion and requested copies of the FDA reviews through the Freedom of Information Act (FOIA). The FDA has now published the conclusions from those reviews in the Federal Register, and has given a Notice of Opportunity for Hearing (NOOH) to Vanda, which the company has now 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).

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top