FDA lifts partial clinical hold on Vanda Pharmaceuticals’ tradipitant

Vanda Pharmaceuticals (VNDA) announced that the FDA has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant. The lift followed Vanda’s formal dispute resolution request and an expedited re-review conducted by 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. The Agency therefore 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. This decision allows Vanda to extend clinical studies of tradipitant in motion sickness. Separately, the ongoing review of the pending, fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track, with a PDUFA target action date of December 30, 2025.