A bold truth: motion sickness treatment is entering a new era, and this change could affect how millions feel during travel. Here’s how the latest development unfolds and why it matters.
Vanda Pharmaceuticals reports that the FDA has lifted the partial clinical hold on protocol VP-VLY-686-3403 for tradipitant, removing the previous limit of 90 doses. The decision comes after Vanda submitted a formal dispute resolution and an expedited re-review led by CDER leadership, built on the collaborative framework the company established with the FDA in October 2025.
The FDA agreed with Vanda’s position: motion sickness is an acute, self-limiting physiological response rather than a chronic condition. Because of this, tradipitant is viewed as an acute, event-driven therapy, eliminating the need for an additional six-month dog toxicity study. With the hold lifted, the company can extend clinical studies of tradipitant for motion sickness. Separately, the ongoing NDA review for tradipitant to prevent vomiting caused by motion continues, with a PDUFA target action date of December 30, 2025. If approved, tradipitant could become the first new pharmacologic treatment for motion sickness in more than four decades.
Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO, applauded the FDA’s thorough and expedited scientific review and emphasized the value of the ongoing collaboration. He expressed appreciation for the agency’s proactive, rigorous assessment and said Vanda looks forward to continued constructive dialogue.
About Vanda Pharmaceuticals
Vanda is a global biopharmaceutical leader focused on developing and commercializing therapies that address significant unmet medical needs and improve patients’ lives. More information about Vanda can be found at vandapharma.com, and the company maintains a presence on X at @vandapharma.
About Tradipitant
Tradipitant is a neurokinin-1 receptor antagonist licensed to Vanda from Eli Lilly and Company. It is being developed for multiple indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.
Forward-looking statements
This press release contains forward-looking statements about Vanda’s development plans for tradipitant, the NDA review process, potential commercialization, and ongoing FDA interactions. These statements reflect current expectations and involve risks and uncertainties that could cause actual results to differ. Notable factors include the FDA’s final review outcome for the motion sickness indication, safety and efficacy assessments, and the ability to continue productive collaboration with the FDA. Readers should consider the cautionary notes and risk factors discussed in Vanda’s most recent SEC filings. Vanda undertakes no obligation to update these statements unless required by law.
Contacts
Corporate: Kevin Moran, Senior Vice President, CFO & Treasurer, Vanda Pharmaceuticals, 202-734-3400, email protected
Press inquiries: Collected Strategies team, email protected
Source: Vanda Pharmaceuticals Inc.
