On December 30, 2025, the U.S. Food and Drug Administration approved NEREUS™ (tradipitant) for the prevention of motion-induced vomiting. This decision represents the first approval of a fundamentally new pharmacologic mechanism for motion sickness in more than four decades, addressing a condition that affects an estimated 78 million adults in the United States.
The approval ends a long period of therapeutic stagnation and introduces a modern, mechanism-driven alternative to legacy treatments.
🧠 A New Mechanism in Neuropharmacology #
Since the approval of the scopolamine transdermal patch in 1979, motion sickness therapy has relied almost entirely on anticholinergics and antihistamines. While effective for some patients, these drugs are often associated with sedation, cognitive impairment, and antimuscarinic side effects.
NEREUS™ represents a clean mechanistic break from these approaches:
- Mechanism of Action: Selective neurokinin-1 (NK-1) receptor antagonist
- Biological Target: Inhibition of Substance P, a central neurotransmitter that activates the vomiting reflex in response to sensory conflict
By acting directly on the emetic signaling pathway in the central nervous system, tradipitant prevents vomiting without the sedative burden common to older agents.
🚢 Clinical Validation in Real-World Conditions #
FDA approval was supported by a comprehensive clinical program enrolling more than 800 participants. The pivotal evidence came from two Phase 3 “provocation” studies—Motion Syros and Motion Serifos—conducted aboard vessels in open water, where motion stimuli are unpredictable and severe.
Phase 3 Efficacy Outcomes #
| Study | NEREUS™ Vomiting Rate | Placebo Vomiting Rate | Relative Risk Reduction |
|---|---|---|---|
| Motion Syros | ~18.3% | 44.3% | ~58% |
| Motion Serifos | ~10.4% | 37.7% | ~72% |
Across both trials, tradipitant consistently demonstrated statistically and clinically meaningful reductions in vomiting, validating its effectiveness under real-world travel conditions rather than artificial laboratory models.
🔬 Platform Strategy Beyond Motion Sickness #
While motion sickness approval is a major milestone, Vanda Pharmaceuticals is positioning tradipitant as a broader anti-emetic and neuro-gastrointestinal platform therapy.
GLP-1–Associated Nausea and Vomiting #
The widespread adoption of GLP-1 receptor agonists for obesity and diabetes has exposed a major unmet need: treatment-limiting nausea and vomiting. In late 2025, Vanda reported positive Phase 2 data showing that tradipitant reduced vomiting frequency by approximately 50% in patients experiencing GLP-1–related gastrointestinal side effects.
A Phase 3 program targeting this rapidly expanding patient population is expected to initiate in the first half of 2026.
Gastroparesis #
Tradipitant also remains under development for gastroparesis, a chronic disorder characterized by delayed gastric emptying and severe nausea. Although a 2024 Complete Response Letter cited the need for additional long-term safety data, the FDA’s approval of tradipitant for acute motion sickness use strengthens the drug’s regulatory foundation and may simplify future pathways for chronic indications.
🚀 Commercial Launch Outlook #
Vanda plans to launch NEREUS™ in the U.S. market in the coming months of 2026. Its oral capsule formulation, combined with a non-sedating profile, positions it as a compelling option for travelers, maritime and aviation professionals, military personnel, and patients with severe motion sensitivity.
With the approval of NEREUS™, motion sickness treatment enters its first truly modern era—one defined by targeted neuropharmacology rather than compromise-driven symptom control.