NEREUS (tradipitant) receives FDA approval as the first new motion sickness therapy in 40+ years, offering targeted prevention of vomiting and new treatment possibilities for patients.
Written By: Pharmacally Medical News Desk
Vanda Pharmaceuticals has received FDA approval for NEREUS (Tradipitant), the first new pharmacologic option in more than four decades designed specifically to prevent vomiting triggered by motion. The company describes the approval as a milestone grounded in modern neuropharmacology and backed by rigorous clinical data.
NEREUS is an oral neurokinin-1 (NK-1) receptor antagonist. Motion sickness occurs when visual, vestibular, and proprioceptive signals conflict, activating substance P pathways in the brain that drive nausea and vomiting. By blocking NK-1 receptors, Tradipitant directly interrupts this cascade rather than simply masking symptoms.
Vanda’s CEO Mihael H. Polymeropoulos says the FDA approval reflects strong scientific evidence showing NEREUS prevents motion-related vomiting. He highlights that it is the first new therapy for motion sickness in more than 40 years, offers modern, targeted prevention beyond current options, and represents a historic milestone made possible by the company’s teams, study participants, and regulators.
Clinical evidence behind the approval
The approval is supported by three pivotal trials, including two Phase 3 “real-world” boat studies:
Motion Syros (NCT04327661) (n=365): Vomiting occurred in 18.3–19.5% of participants taking NEREUS vs. 44.3% with placebo.
Motion Serifos (NCT05903924) (n=316): Vomiting rates were 10.4–18.3% with NEREUS vs. 37.7% with placebo, translating to risk reductions greater than 50–70%.
Across studies, the treatment showed consistent benefit and a safety profile suitable for acute, situational use.
Trial | N | NEREUS™ Vomiting Rate | Placebo Vomiting Rate | Risk Reduction |
365 | 18.3–19.5% | 44.3% | ~58% | |
Motion Serifos | 316 | 10.4–18.3% | 37.7% | 50–70% |
Additional peer-reviewed data also support the role of Tradipitant in motion sickness. A Neurology publication reported that Tradipitant reduced vomiting across a range of real-world sea conditions, reinforcing the consistency of benefit observed in controlled trials
Motion sickness is common. About 25–30% of adults in the United States experience symptoms during travel, and a sizable minority report severe, recurring episodes that disrupt daily life. According to Vanda, a meaningful share of patients continues to experience inadequate control with available therapies, and some ultimately avoid motion-provoking activities because of recurring symptoms. The arrival of a targeted therapy could reshape management for patients whose symptoms remain poorly controlled.
Historical and real-world relevance
Motion sickness has long been recognized as more than an inconvenience. Military history shows its operational impact, most notably during World War II deployments. Today, the burden spans everyday travel, tourism, and professional environments where performance matters. NEREUS represents a therapy informed by decades of research into the physiology behind motion-induced vomiting
Safety and use considerations
In placebo-controlled trials, the most reported side effects were somnolence and fatigue. Because NEREUS may impair alertness, patients should be cautioned about driving or operating machinery, especially if taking other central nervous system depressants or strong CYP3A4 inhibitors. Use is not recommended in severe renal impairment or in patients with any degree of hepatic impairment. It has not been studied in pediatric populations.
Label indication
NEREUS is approved for the prevention of vomiting induced by motion in adults. Full prescribing information is available through the product site.
Beyond motion sickness
Vanda is advancing tradipitant for additional conditions in which substance P-mediated pathways are thought to play a role, including:
- Gastroparesis
- Prevention of nausea and vomiting associated with GLP-1 receptor agonists
With approval achieved, the company plans to launch NEREUS in the coming months while continuing clinical development across related indications.
NEREUS marks a rare development in motion sickness care: a novel, mechanism-based therapy validated in real-world settings. For patients whose symptoms are severe, disruptive, or insufficiently controlled by existing options, this approval opens the door to a new preventive strategy grounded in current neurobiology.
References
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, 30 December 2025, https://vandapharmaceuticalsinc.gcs-web.com/node/16681/pdf
Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness, ClinicalTrials.gov ID NCT04327661, https://clinicaltrials.gov/study/NCT04327661
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness, ClinicalTrials.gov ID NCT05903924, https://www.clinicaltrials.gov/study/NCT05903924
Vasilios M. Polymeropoulos et al, Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study, Front. Neurol., 04 March 2025, Sec. Neuro-Otology, Volume-16-2025 https://doi.org/10.3389/fneur.2025.1550670
Vasilios Polymeropoulos, Tradipitant Effective in the Reduction of Vomiting Associated with Motion Sickness Across Varied Sea Conditions (S3.003), Neurology, April 9, 2024 issue 102 (7_supplement_1) 3313, https://doi.org/10.1212/WNL.0000000000205059