FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion

Announced by parent company Vanda Pharmaceuticals Inc. on December 30, 2025, the US Food and Drug Administration (FDA) has approved tradipitant under the brand name NEREUS for the prevention of vomiting induced through motion sickness.1

“This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS in motion sickness,” Mihael Polymeropoulos, MD, president, chief executive officer, and chairman of the board of Vanda Pharmaceuticals, said in a statement. “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.”1

Motion sickness is prevalent in daily life, with roughly 25-30% of adults exhibiting symptoms during common modes of travel, including cars, planes, or boats. Around 1 in 3 individuals worldwide are highly susceptible, and although most cases are mild, roughly 5-15% of the population experiences recurrent and severe symptoms which can impact quality of life significantly. The condition arises from a sensory conflict between visual, vestibular, and proprioceptive inputs, which causes the release of substance P and the activation of NK-1 receptors in the central nervous system.1

The FDA’s decision was based on data from 2 pivotal phase 3 trials, Motion Syros and Motion Serifos, both of which were provocation studies conducted on boats. Motion Syros was a randomized, double-blind, placebo-controlled study involving patients aged 18-75 years with a history of motion sickness. Investigators excluded patients with nausea-inducing disorders other than motion sickness, a body mass index (BMI) >40, and a history of intolerance and/or hypersensitivity to NK-1 receptor antagonists.2

A total of 365 participants were enrolled in the trial and randomly assigned in a 1:1:1 ratio to either 170 mg (n = 120) or 85 mg (n = 123) of tradipitant, or placebo (n = 120). Patients embarked on a series of 4-hour boat trips in variable sea conditions, during which symptoms of vomiting and nausea were evaluated with questionnaires every 30 minutes. The primary efficacy endpoint was the percentage of vomiting during vehicle travel.2

Ultimately, Motion Syros saw substantially lower vomiting incidence in both dosing arms of tradipitant compared to placebo, which stayed consistent across all boat groups (170 mg tradipitant, 18.3%; 85 mg tradipitant, 19.5%; placebo, 44.3%; P <.0001). Additionally, tradipitant prevented severe nausea and vomiting as compared to placebo (18.03% vs 37.7%; P<.0001).2

Motion Serifos was another randomized, double-blind, placebo-controlled study with the same inclusion and exclusion criteria as Motion Syros. A total of 316 patients were included and randomly assigned in a 1:1:1 ratio to the same doses of tradipitant and placebo. Ultimately, investigators noted substantially lower vomiting among patients receiving tradipitant compared to placebo (170 mg tradipitant, 10.4%; 85 mg tradipitant, 18.3%; placebo, 37.7%) and greater prevention of severe nausea and vomiting among tradipitant recipients versus placebo (13.3% vs 33%; P = .00003).3

“We are proud of this historic milestone and grateful to the Vanda researchers, patients, investigators, and regulators who contributed to this achievement,” Polymeropoulos said.1

According to the press release, Vanda Pharmaceuticals plans to launch tradipitant commercially in the coming months.1

References

1. Vanda Pharmaceuticals Inc. 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. PR Newswire. December 30, 2025. Accessed December 31, 2025. 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. 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

3. Vanda Pharmaceuticals Inc. Vanda Pharmaceuticals Reports Positive Results from a Second Phase III Study of Tradipitant in Motion Sickness. May 16, 2024. Accessed December 31, 2025. https://edge.prnewswire.com/c/link/?t=0&l=en&o=4587679-1&h=246048005&u=https%3A%2F%2Fvandapharmaceuticalsinc.gcs-web.com%2Fnode%2F15956%2Fpdf&a=here