Tradipitant FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 10, 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.
The FDA has set September 18, 2024 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA). If approved, tradipitant will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years.
Tradipitant is also being studied for the treatment of motion sickness and atopic dermatitis.

Development timeline for tradipitant

Date	Article
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

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