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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
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