On December 30, 2025, Vanda Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved NEREUS™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion in adults. This approval represents a historic milestone, as it introduces the first new pharmacologic treatment for motion sickness in over 40 years, advancing beyond traditional antihistamines and antimuscarinics like scopolamine patches, which often carry limitations such as drowsiness or limited efficacy.
Motion sickness arises from sensory conflicts between visual, vestibular, and proprioceptive inputs, triggering substance P release and NK-1 receptor activation in the central nervous system, leading to nausea and vomiting. NEREUS™ directly antagonizes this pathway, providing targeted antiemetic effects. Efficacy was demonstrated in three pivotal clinical trials involving participants with documented motion sickness histories. The Phase 3 Motion Syros study (n=365) showed vomiting rates of 18.3-19.5% with tradipitant versus 44.3% with placebo (p<0.0001). The Motion Serifos study (n=316) reported rates of 10.4-18.3% versus 37.7% (p≤0.0014), achieving risk reductions exceeding 50-70%. The drug exhibited a favorable safety profile for acute use, with common adverse reactions including somnolence and fatigue.
Motion sickness affects approximately 25-30% of U.S. adults (65-78 million people), with severe cases impacting quality of life, travel, and even military readiness—historically noted during events like the 1944 D-Day invasion. Globally, up to one-third of individuals are highly susceptible, driving annual demand for treatments.
Vanda’s CEO, Mihael H. Polymeropoulos, M.D., emphasized the approval’s foundation in modern neuropharmacology and gratitude to researchers, patients, investigators, and regulators. The company anticipates a commercial launch in the coming months. Beyond motion sickness, tradipitant is in development for gastroparesis and prevention of nausea/vomiting associated with GLP-1 receptor agonists, expanding NK-1 antagonism’s potential in substance P-mediated conditions. This approval validates a novel therapeutic platform and addresses longstanding unmet needs in a prevalent, debilitating physiologic response.
