FDA Clears Vanda’s NEREUS for Motion‑Induced Vomiting After 40 Years

The Food and Drug Administration approved NEREUS (tradipitant) on Dec. 30, 2025, for the acute prevention of vomiting induced by motion in adults, marking the first new approved pharmacologic therapy for motion sickness in more than 40 years. Vanda Pharmaceuticals said the approval, announced in a company release datelined Washington, was based on two Phase 3 studies and supporting data, including a multicenter, randomized, double‑blind, placebo‑controlled trial published in Frontiers in Neurology earlier this year.

Tradipitant is an oral neurokinin‑1 receptor antagonist licensed to Vanda from Eli Lilly and Company. Vanda has previously reported positive Phase 3 results and disclosed that the program targets additional indications; the company is pursuing clinical development of tradipitant for gastroparesis and for preventing nausea and vomiting associated with GLP‑1 receptor agonists, therapies whose gastrointestinal side effects have limited tolerability for some patients.

The approval shifts a small but visible corner of the antiemetic market. Vanda said it expected to launch NEREUS “in the coming months,” and trading reflected investor enthusiasm immediately after the announcement. Shares rose as much as 18 percent to $8.29, climbing toward the stock’s highest levels in more than three years, and analysts adjusted their outlooks. Jefferies raised its price target on Vanda to $7.50 from $5 and retained a Hold rating, projecting that NEREUS could represent a $100 million to $300 million commercial opportunity and suggesting its pricing could be above existing over‑the‑counter options such as dimenhydrinate, commonly sold as Dramamine.

Industry and company statements stressed the scientific significance of the approval. “This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS™ in motion sickness. For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology, offering effective prevention without the limitations of existing options,” said Mihael H. Polymeropoulos, President, CEO, and Chairman of the Board of Vanda Pharmaceuticals.

Regulatory activity earlier in the review process included an FDA extension in late November and the lifting of a dosing cap on tradipitant studies in early December, actions that preceded the Dec. 30 decision. The company’s public materials referenced an “Indication and Important Safety Information” section but did not provide full label text or dosing specifics in the initial announcement.

Key questions remain for clinicians, regulators and patients. The exact dosing regimen, detailed safety profile and full prescribing information will be set out in the FDA approval letter and the product’s Prescribing Information, documents that have not yet been released in full. Any post‑marketing requirements or limits imposed by the agency will be critical to how broadly NEREUS is used and how quickly Vanda can pursue its planned additional indications.

For travelers, naval and aviation operators, and the growing population prescribed GLP‑1 drugs who experience nausea, the approval promises a modern, targeted option. How rapidly it reaches pharmacies, how it will be priced relative to over‑the‑counter choices, and how the broader clinical trials progress will determine whether tradipitant becomes a routine tool for motion‑sickness prevention or a niche specialty product.