Vanda Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its protocol VP-VLY-686-3403, which previously limited the study to a maximum of 90 doses of tradipitant.

The decision follows Vanda's formal dispute resolution request and an expedited re-review conducted by the Center for Drug Evaluation and Research (CDER) leadership under the collaborative framework established between Vanda and the FDA in October 2025.

The FDA agreed with Vanda's position that motion sickness is an acute, self-limiting physiologic response rather than a chronic or chronic-intermittent condition. As a result, the agency concluded that the use of tradipitant in motion sickness represents an acute, event-driven therapy, eliminating the need for an additional six-month dog toxicity study and rendering the partial clinical hold unnecessary. 

The lift allows Vanda to extend clinical studies of tradipitant in motion sickness. Meanwhile, the review of the fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track. With a PDUFA target action set for December 30, 2025, tradipitant could become the first new pharmacologic treatment for motion sickness in over 40 years.

"The swift and favourable resolution of this issue highlights the effectiveness of our collaborative framework with the FDA. We thank the Agency for its thorough and expedited scientific review and look forward to continued constructive dialogue,” said Mihael H. Polymeropoulos, President and CEO of Vanda.

Tradipitant, a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly, is currently in clinical development for a variety of indications, including gastroparesis, motion sickness, and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.