Recent Updates
Recently added Catalysts
VNDA Positive Sentiment Score: 70/100

Vanda Pharmaceuticals announces the publication of an article on "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" in the Clinical Gastroenterology and Hepatology Journal

Thursday, January 25, 2024 2 min read
Key Takeaway: Vanda Pharmaceuticals announced the publication of a pivotal phase III study on tradipitant's efficacy for diabetic and idiopathic gastroparesis in a peer-reviewed journal. The study's findings will support the company's New Drug Application already submitted to the FDA, which has set a target action date of September 18, 2024. However, there's a current partial clinical hold on tradipitant protocols longer than 12 weeks, which might affect its development timeline.

Market Sentiment Analysis

POSITIVE FACTORS

  • Publication of a pivotal phase III study indicates strong evidence of efficacy.
  • FDA has set a target action date for the New Drug Application.
  • Tradipitant shows promise for treating both diabetic and idiopathic gastroparesis.

CONCERNS & RISKS

  • FDA has imposed a partial clinical hold on tradipitant clinical protocols longer than 12 weeks.

Full Press Release Details

WASHINGTON, Jan. 25, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the publication of an article titled "The Efficacy of Tradipitant in Patients with Diabetic and Idiopathic Gastroparesis in Phase III Randomized Placebo-Controlled Clinical Trial" in the Clinical Gastroenterology and Hepatology Journal1 which follows a previously published study of tradipitant in the treatment of gastroparesis in 2021.2 The findings of this pivotal phase III study are included in the New Drug Application for tradipitant in the treatment of gastroparesis in adults submitted to the U.S. Food and Drug Administration (FDA) The FDA has set a Prescription Drug User Fee Act target action date of September 18, 2024 for its decision.
Carlin, J. L., Polymeropoulos, C., Camilleri, M., Lembo, A., Fisher, M., Kupersmith, C., Madonick, D., Moszczynski, P., Smieszek, S., Xiao, C., Birznieks, G., & Polymeropoulos, M. H. (2024). The efficacy of tradipitant in patients with diabetic and idiopathic gastroparesis in phase III randomized placebo-controlled clinical trial. Clinical Gastroenterology and Hepatology. Available online: https://www.cghjournal.org/article/S1542-3565(24)00050-8/fulltext
Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao, C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H. P., & Polymeropoulos, M. H. (2021). Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Gastroenterology, 160(1), 76–87.e4. Available online: https://doi.org/10.1053/j.gastro.2020.07.029
About Vanda Pharmaceuticals Inc.
Tradipitant is an NK-1R antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis and motion sickness. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration.
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.

21 %

more press release views with

Frequently Asked Questions

What is tradipitant used to treat?

Tradipitant is developed for treating gastroparesis and motion sickness.

When is the FDA's decision date for tradipitant?

The FDA's target decision date for tradipitant is September 18, 2024.

Which journal published the tradipitant study?

The study was published in the Clinical Gastroenterology and Hepatology Journal.

Has tradipitant received FDA approval yet?

No, the New Drug Application for tradipitant is currently under FDA review.

Who licensed tradipitant to Vanda Pharmaceuticals?

Tradipitant was licensed by Vanda from Eli Lilly and Company.

Tags: VNDA Viatris Investor Conferences Healthcare Vanda Pharmaceuticals tradipitant gastroparesis FDA clinical trial
Last updated: Jan 25, 2024