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05 Dec 2025
Admin
News Article

FDA Lifts Partial Clinical Hold on Vanda’s Tradipitant Trial: What This Means for Motion Sickness Treatment

Vanda Pharmaceuticals has secured a major regulatory win. The U.S. FDA has officially lifted the partial clinical hold on the company’s Phase 3 study evaluating tradipitant for motion sickness, removing a key barrier that limited the trial to 90 doses.

This decision opens the door for extended clinical studies and moves tradipitant closer to becoming the first new pharmacologic treatment for motion sickness in more than 40 years.

What Triggered the FDA’s Decision?

Vanda had earlier filed a formal dispute resolution request challenging the need for a long-term six-month dog toxicity study. After an expedited re-review, CDER leadership agreed with Vanda’s scientific position.

The FDA’s revised conclusion:

Motion sickness is an acute, event-driven condition, not a chronic or chronic-intermittent disorder.
Because patients use the drug for short periods, the additional long-term toxicology study was not necessary.
The partial clinical hold was therefore removed.

This quick resolution followed the collaborative framework established between Vanda and the FDA in October 2025.

What This Means for the Tradipitant Program?

With the hold lifted, Vanda can now:

Continue extended dosing and longer-duration clinical studies in motion sickness
Advance development without further preclinical delays

Meanwhile, the New Drug Application (NDA) for tradipitant, intended to prevent vomiting caused by motion, remains under active FDA review.

Key milestone:

PDUFA decision date: December 30, 2025

If approved, tradipitant could become a landmark therapy in a field that has seen no new pharmacologic advances in decades.

Company Commentary

Mihael H. Polymeropoulos, M.D., President & CEO of Vanda, stated:

“The swift and favorable resolution highlights the effectiveness of our collaborative framework with the FDA. We appreciate the Agency’s expedited review and look forward to continued constructive dialogue.”

About Tradipitant

Tradipitant is a neurokinin-1 (NK-1) receptor antagonist, originally licensed from Eli Lilly. It is in development for several indications, including:

Motion sickness
Gastroparesis
GLP-1–induced nausea and vomiting

About Vanda Pharmaceuticals

Vanda is a global biopharmaceutical company focused on innovative therapies for unmet medical needs. The company continues to expand its late-stage pipeline and strengthen its presence in CNS and gastrointestinal disorders.

Learn more at vandapharma.com or follow Vanda on X (@vandapharma).

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