Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis
Phase of Trial: Phase III
Latest Information Update: 16 Aug 2018
At a glance
- Drugs Metoclopramide (Primary)
- Indications Diabetic gastroparesis
- Focus Registrational; Therapeutic Use
- Sponsors Evoke Pharma
- 16 Aug 2018 According to an Evoke Pharma media release, NDA for Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis has been accepted for review by the U.S. FDA and set a target goal date under the Prescription Drug User Fee Act (PDUFA) of April 1, 2019.
- 04 Jun 2018 According to an Evoke Pharma media release, the company has submitted 505(b)(2) New Drug Application (NDA) to the US FDA for Gimoti (metoclopramide) nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
- 10 May 2017 Results published in the Evoke Pharma media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History