FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness

Core Insights - The U.S. FDA has lifted the partial clinical hold on Vanda Pharmaceuticals' protocol for tradipitant, allowing for an increase in the maximum number of doses administered in clinical studies [1][4] - This decision follows a formal dispute resolution request by Vanda and an expedited re-review by the FDA, which recognized motion sickness as an acute condition [2][3] - The ongoing review of the New Drug Application (NDA) for tradipitant is on track, with a target action date of December 30, 2025, potentially marking the first new treatment for motion sickness in over 40 years [4] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [5] - Tradipitant, a neurokinin-1 receptor antagonist licensed from Eli Lilly, is in clinical development for various indications, including motion sickness and nausea prevention [6]