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FDA requests, and Vanda agrees to, a brief extension (to December 5, 2025) for the expedited re-review of the partial clinical hold onlong-term studies
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Separately, FDA recently issued labeling comments, and labeling discussions have formally begun for the New Drug Application of tradipitantfor the prevention of vomiting induced by motion (PDUFA target action date remains December 30, 2025)
WASHINGTON, Nov. 28, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), today announced the following updatesregarding tradipitant for motion sickness:
Partial Clinical Hold Re-Review Timeline
Under the collaborative framework announced on October 1, 2025, the U.S. Food and Drug Administration (FDA) is conducting an expedited re-reviewof the partial clinical hold that currently restricts long-term clinical studies of tradipitant in motion sickness. The original target completion date wasNovember 26, 2025. At the FDA's request, and with Vanda's agreement, the target completion date has been extended to December 5, 2025 toaccommodate recent personnel and leadership transitions within the Center for Drug Evaluation and Research (CDER). All other provisions of thecollaborative framework remain unchanged.
New Drug Application (NDA) Progress
Separately, review of the NDA for tradipitant for the prevention of vomiting induced by motion continues according to schedule, with an unchangedPDUFA target action date of December 30, 2025. The FDA has recently issued comments on the proposed labeling, and labeling discussions betweenthe FDA and Vanda have now formally commenced. Vanda looks forward to potentially delivering the first new pharmacologic treatment for motionsickness in over four decades.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address highunmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow uson X @vandapharma.About TradipitantTradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for avariety of indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.