Vanda Pharmaceuticals Inc. (VNDA) announced Friday that the FDA is conducting an expedited re-review of the partial clinical hold currently limiting long-term clinical studies of tradipitant for motion sickness. Here's the twist: they're moving faster on the review itself, but the timeline just got slightly longer.
The original target completion date was November 26, 2025. Now it's December 5th. The reason? Recent personnel and leadership transitions within the FDA's Center for Drug Evaluation and Research. The agency asked for the extension, and Vanda agreed.
That's actually the less important timeline. The motion sickness application itself continues marching toward its PDUFA target action date of December 30, 2025, completely unchanged. The FDA recently issued comments on proposed labeling, and formal labeling discussions between the agency and Vanda have officially kicked off. When regulators start negotiating what goes on the label, that's typically a good sign.
If everything goes according to plan, tradipitant could become the first new pharmacologic treatment for motion sickness in over four decades. That's a long time to go without fresh options for a condition that affects millions of travelers.
The backdrop here matters. Earlier in 2025, the FDA refused a different new drug application from Vanda for tradipitant in gastroparesis, citing lack of confirmatory evidence. The agency recommended conducting two new, well-designed clinical trials in adults with idiopathic or diabetic gastroparesis, plus a long-term toxicity study in a non-rodent species. So the motion sickness indication represents a separate, still-viable path forward for the drug.
VNDA Price Action: Vanda Pharmaceuticals shares were up 0.66% at $5.33 at the time of publication on Friday.
