WASHINGTON — Vanda Pharmaceuticals said Tuesday the U.S. Food and Drug Administration has approved Nereus (tradipitant), an oral drug to prevent vomiting induced by motion. The Nereus FDA approval marks the first new FDA-cleared treatment for motion-induced vomiting in more than four decades and sets up a U.S. launch in the coming months, Dec. 30, 2025.
In Vanda’s announcement, the company said the decision was supported by three pivotal clinical trials, including two Phase 3 “real-world” provocation studies conducted on boats. Those Phase 3 trials enrolled 681 participants in total, and vomiting occurred in roughly 10% to 20% of people given Nereus compared with about 38% to 44% of those on placebo, the company said.
Nereus is a neurokinin-1 (NK-1) receptor antagonist that targets substance P signaling involved in nausea and vomiting. The Motion Syros Phase 3 results were later described in a peer-reviewed Frontiers in Neurology paper. In placebo-controlled studies, somnolence and fatigue were the most commonly reported adverse reactions after a single dose, and the label warns the drug may impair tasks requiring full alertness, including driving.
Nereus FDA approval: what the FDA cleared
After the Nereus FDA approval, clinicians have a new option specifically indicated for the prevention of vomiting induced by motion in adults. Vanda’s chief executive, Mihael H. Polymeropoulos, president, CEO and chairman of the board, called the decision a turning point: “For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology.”
A crowded category, but a new mechanism
Most motion sickness products are older antihistamines, while the main prescription alternative has been scopolamine. In a report carried by Reuters, the approval was also framed as a commercial opportunity: H.C. Wainwright analyst Raghuram Selvaraju estimated tradipitant sales in this indication could top $100 million a year at peak in the U.S. The company has not disclosed pricing and said it expects to launch Nereus in the coming months.
The long road to Nereus FDA approval
Tradipitant has been in Vanda’s portfolio since it licensed the drug from Eli Lilly in 2012, but development has been marked by disputes over long-term safety study requirements. A 2020 Fierce Biotech report detailed how a federal judge sided with the FDA in a case tied to a partial clinical hold and the agency’s request for additional chronic toxicity data before longer studies could proceed.
Even as Vanda built its motion sickness data set, tradipitant’s progress in other indications remained uneven. A 2023 Medthority report summarized early boat-study results and noted the FDA had not approved a new motion sickness medication since the scopolamine patch in 1979. In September 2024, Reuters reported the FDA declined to approve tradipitant for gastroparesis and asked for additional studies — a reminder that the same molecule could face very different regulatory expectations depending on whether it is positioned for acute or chronic use.
For travelers, the Nereus FDA approval shifts the conversation from “whether” to “how” — including coverage, access and whether prescribers see it as an add-on or a replacement for older options. For Vanda, the Nereus FDA approval provides a new commercial foothold as it continues to test tradipitant in other nausea-driven conditions.
