On December 4, 2025 the U.S. Food and Drug Administration removed the partial clinical hold that had limited Vanda Pharmaceuticals’ tradipitant protocol VP‑VLY‑686‑3403 to a maximum of 90 doses. The hold had prevented the company from enrolling additional patients and conducting the full dose‑range studies needed for a motion‑sickness indication.
The FDA concluded that motion sickness is an acute, event‑driven condition, not a chronic or intermittent disorder, and therefore does not require the additional six‑month dog toxicity study that had been mandated under the hold. This regulatory determination allowed the agency to expedite the review and lift the restriction without further pre‑clinical work.
With the hold lifted, Vanda can now expand its clinical trials and accelerate progress toward a potential approval for motion‑sickness treatment. The company’s New Drug Application for the same indication remains on track, with a PDUFA target action date of December 30, 2025. The clearance removes a significant development bottleneck and positions Vanda closer to delivering the first new pharmacologic therapy for motion sickness in more than four decades, a market that has lacked a modern treatment option.
Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals, said, “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.”
Vanda’s financial performance in the most recent quarter showed a modest revenue decline to $56.3 million, below the $58.83 million expected, and an earnings‑per‑share loss of $0.38 versus an anticipated $0.43 loss. The company’s gross margin remained high at 94.44%, but profitability remained negative as the company continues to invest heavily in clinical development. Analysts project that Vanda will achieve profitability in 2025 with an EPS forecast of $0.88. The lift of the clinical hold is expected to enhance the company’s pipeline value, potentially improving future revenue prospects and supporting the company’s long‑term growth strategy.
The announcement was well received by investors, reflecting confidence in Vanda’s pipeline and the regulatory progress achieved. The lift of the hold is viewed as a key milestone that could accelerate the company’s path to market approval and commercial launch for tradipitant.
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