Tradipitant FDA Approval Status

Last updated by Judith Stewart, BPharm on Oct 3, 2024.

FDA Approved: No
Generic name: tradipitant
Company: Vanda Pharmaceuticals Inc.
Treatment for: Gastroparesis

Tradipitant is a neurokinin 1 receptor (NK-1R) antagonist in development for the treatment of symptoms of gastroparesis.

Gastroparesis is a condition thought to be caused by dysregulation of the neuromuscular control of gastric movements that result in the timely emptying of stomach contents. Symptoms include nausea, vomiting, bloating, fullness after meals and abdominal pain.
Tradipitant works by blocking neurokinin 1 receptors and is thought to have a dual and potentially therapeutic effect in gastroparesis by affecting gastric motility through a local action as well as affecting the brain regions responsible for nausea and vomiting.
Tradipitant is also being studied for the treatment of motion sickness and atopic dermatitis.

Development timeline for tradipitant

Date	Article
Sep 19, 2024	FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
Dec 4, 2023	Vanda Pharmaceuticals Announces that U.S. Food and Drug Administration Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis
Feb 4, 2022	Vanda Pharmaceuticals Reports Results from the Phase III Study of Tradipitant in Gastroparesis
Dec 3, 2018	Vanda Announces Positive Phase II Study Results for Tradipitant in Patients with Gastroparesis

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.