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Details:
Gimoti (metoclopramide) increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2023
Details:
Gimoti (metoclopramide) nasal spray is a dopamine receptor antagonist to treat nausea and vomiting in patients with gastroesophageal reflux disease or diabetic gastroparesis by increasing movements or contractions of the stomach and intestines.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
The company developed, commercialized and markets GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
GIMOTI (metoclopramide) is a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults. Diabetic gastroparesis is a GI disorder in which the stomach takes too long to empty its contents.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Details:
GIMOTI is the first and only FDA-approved novel nasal formulation of metoclopramide that is commercially available and specifically designed to deliver a non-oral dose of metoclopramide for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2022
Details:
GIMOTI (metoclopramide) is first and only FDA-approved nasal formulation of metoclopramide that is commercially available and specifically designed to deliver non-oral dose of metoclopramide for relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 20, 2022
Details:
GIMOTI, a nasal spray formulation of metoclopramide, is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2022
Details:
Gimoti (metoclopramide) nasal spray, is a dopamine-2 (D2) antagonist is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2022
Details:
Presented as a Poster of Distinction at Digestive Disease Week (DDW) 2022, showed a 98.8 per 100,000 (0.1%) incidence of TD among gastroparesis patients treated with Gimoti (metoclopramide).
Lead Product(s): Metoclopramide
Therapeutic Area: Neurology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
GIMOTI, a nasal spray formulation of metoclopramide, for relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults, 100% of current GIMOTI users report seeing at least some symptom improvement; diminished nausea is most cited symptom improvement.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Details:
Gimoti™ is a nasal spray launched for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Product launch provides healthcare providers a novel treatment approach for patients suffering from symptoms of acute and recurrent diabetic gastroparesis.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Gimoti
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eversana
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
USFDA has conditionally accepted the proprietary brand name, “Gimoti,” for the Evoke's nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in the 505 New Drug Application.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2020
Details:
Under the terms of the agreement, Evoke retains Gimoti NDA rights as well as all legal, regulatory and production obligations, while EVERSANA will sell and supply Gimoti in the United States.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eversana
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 23, 2020
Details:
A six-month period of review from the FDA’s date of receipt has been assigned for the resubmitted NDA and the PDUFA target goal date is June 19, 2020.
Lead Product(s): Metoclopramide
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2020
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