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?

Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis

Next Previous
Trial Profile

Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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 Metoclopramide (Primary)
  • Indications Diabetic gastroparesis
  • Focus Registrational; Therapeutic Use
  • Sponsors Evoke Pharma

Most Recent Events

  • 19 Jun 2020 According to an Evoke Pharma media release, U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for GIMOTI(metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
  • 23 Jan 2020 According to an Evoke Pharma media release, the U.S. Food and Drug Administration (FDA) has set a target goal date under the Prescription Drug User Fee Act (PDUFA) of June 19, 2020.
  • 20 Dec 2019 According to an Evoke Pharma media release, the resubmission includes 3-month stability data from commercial scale registration batches that met all product specifications and support the proposed acceptance criteria for performance characteristics and device quality control and includes data from an analysis of pump performance characteristics for the product used in the comparative bioavailability study and the product from commercial scale registration batches.

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