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Highlights
- FDA extends expedited re-review of tradipitant partial clinical hold to December 5, 2025.
- NDA labeling discussions formally underway, with PDUFA target action date unchanged at December 30, 2025.
- Tradipitant could become the first new pharmacologic treatment for motion sickness in over 40 years.
Vanda Pharmaceuticals Inc. (Nasdaq:VNDA) has provided a regulatory update on tradipitant, its investigational therapy for motion sickness. The company confirmed an FDA-requested extension for the expedited re-review of the partial clinical hold on long-term studies, while the New Drug Application (NDA) for tradipitant continues to progress on schedule, with the PDUFA target date remaining December 30, 2025.
FDA Extends Partial Clinical Hold Review
Under a collaborative framework established on October 1, 2025, the FDA has been conducting an expedited re-review of the partial clinical hold affecting long-term studies of tradipitant in motion sickness. The original review completion date was November 26, 2025. At the FDA’s request and with Vanda’s agreement, the target date has been extended to December 5, 2025. The extension accommodates personnel and leadership transitions within the Center for Drug Evaluation and Research (CDER). Vanda emphasized that all other aspects of the collaborative framework remain unchanged.
NDA Progress for Motion Sickness Indication
In parallel, the review of tradipitant’s NDA for the prevention of vomiting induced by motion continues according to the previously established timeline. The FDA has issued comments on the proposed labeling, and formal discussions between the agency and Vanda have now begun. The NDA review is proceeding with a PDUFA target action date of December 30, 2025. If approved, tradipitant would mark the first new pharmacologic therapy for motion sickness in more than four decades.
Company Background and Clinical Scope
Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing and commercializing innovative therapies to address unmet medical needs. Tradipitant, a neurokinin-1 receptor antagonist licensed from Eli Lilly and Company, is under clinical investigation for several indications, including gastroparesis, motion sickness, and nausea and vomiting prevention associated with GLP-1 receptor agonist treatments. The therapy has advanced through multiple clinical programs, highlighting its potential across diverse patient populations.
Forward-Looking Statements
Vanda continues to engage with the FDA to complete the re-review of the partial clinical hold and finalize labeling for tradipitant’s motion sickness indication. The company expects regulatory guidance and feedback to inform the next stages of clinical and commercial planning, pending completion of the December deadlines.
