Vanda Pharmaceuticals Gains FDA Approval to Advance Tradipitant for Motion Sickness Treatment

Vanda Pharmaceuticals Secures FDA Approval to Advance Tradipitant for Motion Sickness Treatment

Vanda Pharmaceuticals Inc. announces a significant milestone in its clinical development program for tradipitant, a novel treatment for motion sickness. On December 4, 2025, the U.S. Food and Drug Administration (FDA) lifts the partial clinical hold on Vanda’s protocol VP-VLY-686-3403. Previously, this hold limited the administration of tradipitant to a maximum of 90 doses, which hindered the drug’s potential for broader application. The FDA's decision follows Vanda’s formal dispute resolution request and a re-review by the FDA’s Center for Drug Evaluation and Research (CDER), which ultimately supports Vanda's assertion that motion sickness is an acute condition, rather than a chronic one.

This ruling allows for tradipitant to be utilized as an acute, event-driven therapy, thus removing the requirement for an additional six-month dog toxicity study. Vanda can now extend its clinical studies for tradipitant, enhancing its prospects of providing an effective solution for individuals suffering from motion sickness. The company is on track with its New Drug Application for tradipitant, which is designed to prevent vomiting induced by motion. The FDA has a Prescription Drug User Fee Act (PDUFA) target action date set for December 30, 2025, and if approved, tradipitant would mark the first new pharmacologic treatment for motion sickness in over four decades.

Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals, expresses appreciation for the FDA’s expedited review and emphasizes the importance of the collaborative framework between the agency and the company. This development not only reinforces Vanda's commitment to addressing unmet medical needs but also positions tradipitant as a promising candidate in a market that has seen little innovation for years. In addition to motion sickness, Vanda is also exploring the drug's potential for other indications, including gastroparesis and the prevention of nausea and vomiting related to GLP-1 receptor agonists, enhancing its relevance in the expanding landscape of gastrointestinal therapies.

As Vanda Pharmaceuticals continues to navigate the complexities of drug development, the recent FDA decision represents a pivotal moment for the company and the field of motion sickness treatment. The successful progression of tradipitant could lead to an essential option for patients, reaffirming Vanda's role as a leader in developing innovative therapies that meet pressing medical needs. For further information, individuals can visit Vanda's website and follow their updates on social media.