Vanda Pharmaceuticals provides regulatory update on tradipitant

Vanda Pharmaceuticals (VNDA) announced the following updates regarding tradipitant for motion sickness. Partial Clinical Hold Re-Review Timeline: Under the collaborative framework announced on October 1, 2025, the U.S. FDA is conducting an expedited re-review of the partial clinical hold that currently restricts long-term clinical studies of tradipitant in motion sickness. The original target completion date was November 26, 2025. At the FDA’s request, and with Vanda’s agreement, the target completion date has been extended to December 5, 2025 to accommodate recent personnel and leadership transitions within the Center for Drug Evaluation and Research. All other provisions of the collaborative framework remain unchanged. New Drug Application Progress: Separately, review of the NDA for tradipitant for the prevention of vomiting induced by motion continues according to schedule, with an unchanged PDUFA target action date of December 30, 2025. The FDA has recently issued comments on the proposed labeling, and labeling discussions between the FDA and Vanda have now formally commenced. Vanda looks forward to potentially delivering the first new pharmacologic treatment for motion sickness in over four decades.