Vanda Pharmaceuticals Inc., a biopharmaceutical company, announced FDA approval of NEREUS™ (tradipitant), the first new pharmacological treatment for motion sickness in more than 40 years. NEREUS™ is an oral substance P/neurokinin-1 (NK-1) receptor antagonist, which is approved for the prevention of vomiting induced by motion in adults. This approval represents a significant advancement in the management of motion sickness. It is a condition that affects a substantial portion of the population and has historically impacted both civilian travel and military operational readiness. NEREUS™ offers a modern and mechanism-based alternative to current therapies that often have limited efficacy or tolerability. It targets the NK-1 receptor pathway, which plays a central role in the mediation of nausea and vomiting.
The FDA approval was supported by robust clinical evidence from three pivotal studies, including two Phase 3 real-world provocation trials conducted on boats (Motion Syros and Motion Serifos). These trials enrolled participants with documented histories of motion sickness and demonstrated that NEREUS™ significantly reduced vomiting rates compared with placebo. Risk reductions ranged from 50% to 70%, and the drug exhibited a favourable safety profile for acute use. These results validate the scientific rationale for NK-1 receptor antagonism and confirm NEREUS™’s effectiveness in preventing motion-induced vomiting under real-world conditions. Vanda anticipates launching NEREUS™ in the coming months, providing patients with a long-awaited new option for motion sickness prevention.
Motion sickness remains a widespread condition, affecting 25-30% of adults in the U.S., or an estimated 65-78 million people, during routine travel by plane, car, or boat. Up to one-third of individuals worldwide are considered highly susceptible. While symptoms are mild for many, 5 to 15% of people experience severe and recurrent motion sickness that can significantly impair daily functioning and quality of life. This includes individuals whose symptoms are inadequately controlled by current treatments or who avoid travel and motion-sickness-related activities due to symptom severity. Around 10 million people seek pharmacological treatment each year, mainly through over-the-counter treatments, though many need prescription options when symptoms persist. Motion sickness arises from a sensory mismatch among visual, vestibular, and proprioceptive signals, leading to the release of substance P and activation of NK-1 receptors in the central nervous system, the primary pathway targeted by NEREUS™.
Regarding safety, clinical trials found that fatigue and somnolence were the most frequent side effects, affecting a modest proportion of patients at higher doses. Patients are advised not to drive or operate heavy machinery while taking NEREUSTM due to potential impairment of mental or physical capacities. Caution is especially warranted when co-administered with potent CYP3A4 inhibitors or other central nervous system depressants, which can increase drug exposure. Although tradipitant has been detected in animal milk, there is limited human data regarding its use during pregnancy and breastfeeding, and breastfed infants should be monitored for drowsiness. It is not advised to use NEREUSTM in juvenile patients or those with severe renal impairment or any degree of hepatic impairment, as it has not been proven to be safe or effective in these populations. While no specified contraindications have been identified, potential drug-drug interactions should be carefully considered.
Vanda continues the clinical development of tradipitant for additional indications mediated by substance P pathways, including gastroparesis and nausea and vomiting associated with GLP-1 receptor agonists. They are increasingly used in the treatment of diabetes and obesity. Actual outcomes may differ based on regulatory, clinical, and commercial factors, as outlined in Vanda’s filings with the U.S. Securities and Exchange Commission.
References: PR Newswire. 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. Published December 30, 2025. Accessed December 31, 2025. 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
