FDA Approves Tradipitant for Prevention of Vomiting From Motion Sickness

The FDA approved tradipitant (Nereus), an oral neurokinin-1 receptor agonist, for the prevention of vomiting induced by motion. This marks the first pharmacological treatment for motion sickness in over 4 decades.

"This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS™ in motion sickness," Mihael H. Polymeropoulos, MD, president, CEO, and chairman of the board at Vanda Pharmaceuticals, said in a news release.¹ "For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology, offering effective prevention without the limitations of existing options."

The approval is supported by data from 2 phase 3 provocation studies that were conducted on boats, the Motion Syros (NCT04327661) and Motion Serifos (NCT05903924) trials. Further, it was supported by an additional study for patients with documented histories of motion sickness. For Motion Syros, the incidence of vomiting was 18.3% for the high-dose medication and 19.5% for the low-dose medication among 365 patients compared with 44.3% with the placebo. For Motion Serifo, the vomiting rates were 10.4% and 18.3% compared with 44.3%, respectively, among 316 patients.¹

For Motion Serifos, investigators reported that both doses were also effective in the prevention of severe nausea and vomiting at 13.3% with tradipitant and 33% with the placebo.²

In both studies, patients included had a history of motion sickness and were aged 18 to 75 years.^3,4 Patients received high-dose tradipitant, low-dose tradipitant, or the placebo, and all participants attended a single boat trip lasting 125 to 265 minutes each. The peak wave height range across trips was between 0.5 m and 2.5 m, and the average wind speed was between 2 knots and 26.1 knots.^3,5

“Motion sickness remains a significant burden for many travelers both in professional and leisurely settings,” the authors of the Motion Syros study said.⁵ “Further studies with tradipitant could examine its use in nontraditional modes of travel, including travel for astronauts. Given the incomplete efficacy and adverse effects of currently available therapies, tradipitant could be of utility for many travelers.”

Motion sickness is a common condition that occurs when a person is in motion while still sitting, such as in a vehicle. It is caused when the eyes, inner ear, and body send conflicting messages to the brain and can result in nausea, breaking out in a cold sweat, or headache.⁶

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REFERENCES

1. Vanda Pharmaceuticals announced FDA approval of Nereus (tradipitant) for the prevention of vomiting induced by motion: a history scientific milestone in the prevention of motion sickness. News release. Vanda Pharmaceuticals. December 30, 2025. Accessed January 2, 2026. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-fda-approval-of-nereus-tradipitant-for-the-prevention-of-vomiting-induced-by-motion-a-historic-scientific-milestone-in-the-prevention-of-motion-sickness-302650965.html

2. Vanda Pharmaceuticals reports positive results from a second phase 3 study of tradipitant in motion sickness. News release. Vanda Pharmaceuticals. May 14, 2024. Accessed January 2, 2026. https://vandapharmaceuticalsinc.gcs-web.com/node/15956/pdf

3. Motion Syros: a study to investigate the efficacy of tradipitant in subjects affected by motion sickness. ClinicalTrials.gov identification: NCT04327661. Updated December 11, 2024. Accessed January 2, 2026. https://clinicaltrials.gov/study/NCT04327661

4. Motion Serifos: a study to investigate the efficacy of tradipitant in participants affected by motion sickness. ClinicalTrials.gov identification: NCT05903924. April 4, 2025. Accessed January 2, 2026. https://www.clinicaltrials.gov/study/NCT05903924

5. Polymeropoulos VM, Kiely L, Bushman ML, et al. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025;16:1550670. Published 2025 Mar 4. doi:10.3389/fneur.2025.1550670

6. Cleveland Clinic. Motion sickness. April 8, 2024. Accessed January 2, 2026. https://my.clevelandclinic.org/health/diseases/12782-motion-sickness