Vanda Pharmaceuticals announced FDA’s approval of Nereus (tradipitant) for the prevention of vomiting induced from motion.

The agency’s approval of Nereus marks the first new pharmacologic treatment for motion sickness to be approved in over four decades.¹

Nereus’ approval represents a significant advancement in both the comprehension and management of the physiologic response that affects a significant portion of the population, along with being recognized as a factor affecting military operational readiness.¹

Motion sickness has been recognized as a critical factor in military operations since World War II, with the most notorious recognition coming from the D-Day invasion of Normandy in 1944, where troop effectiveness was disrupted by severe seasickness.¹

Along with its effects to military operations, motion sickness remains prevalent in civilian life, with approximately 25% to 30% of adults (or roughly 65-78 million people in the U.S.) experiencing symptoms of motion sickness during common travel in common modes of transportation, including cars, planes, or boats.

Globally, up to one-third of individuals are highly susceptible to motion sickness, with most cases being mild. An estimated 5–15% of the population experiences severe, recurrent symptoms that can significantly impact quality of life.

Nereus is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company and is currently in clinical development for a variety of indications, including gastroparesis and the prevention of nausea and vomiting induced by GLP-1 receptor agonists.¹

"This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS™ in motion sickness," said Mihael H. Polymeropoulos, M.D., president, CEO and chairman of the board of Vanda Pharmaceuticals. "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. We are proud of this historic milestone and grateful to the Vanda researchers, patients, investigators, and regulators who contributed to this achievement."

What is FDA’s approval of Nereus based on?

Nereus’ approval is supported by data collected from three pivotal clinical trials, two Phase III real-world provocation studies conducted on boats titled Motion Syros and Motion Serifos respectfully, and one additional supporting study of participants who had documented histories of motion sickness.¹

In the Phase III Motion Syros trial, vomiting incidence was recorded between 18.3% and 19.5% when administered with Nereus compared to 44.3% with placebo, while in Motion Serifos, vomiting rates were recorded between 10.4% and 18.3% with Nereus versus 37.7% with placebo.¹

The results represent risk reductions between 50% and 70% across the program, with Nereus consistently demonstrating significant reductions in vomiting and a favorable safety profile consistent with acute use.¹

Nereus’ approval from FDA validates its pharmacological profile and paves the way for addtional exploration of NK-1 antagonism in related vomit-inducing conditions.

Sources

1. 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 Vanda Pharmaceuticals December 30, 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