Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness

Core Insights - Vanda Pharmaceuticals is undergoing a re-review process with the FDA regarding the partial clinical hold on tradipitant for motion sickness, with a new target completion date set for December 5, 2025 [1][6] - The New Drug Application (NDA) for tradipitant, aimed at preventing vomiting induced by motion, is progressing as scheduled, with a target action date of December 30, 2025 [2][6] - Tradipitant is a neurokinin-1 receptor antagonist developed by Vanda, which is in clinical development for multiple indications, including motion sickness [4] Group 1: FDA Review Process - The FDA is conducting an expedited re-review of the partial clinical hold on tradipitant, with the original completion date extended to accommodate recent personnel changes [1] - The NDA review for tradipitant continues on schedule, with the FDA having issued comments on the proposed labeling [2][6] Group 2: Product Development - Tradipitant is being developed for various indications, including motion sickness and nausea prevention related to GLP-1 receptor agonists [4] - Vanda aims to potentially deliver the first new pharmacologic treatment for motion sickness in over 40 years [2]