Vanda Pharmaceuticals received U.S. Food and Drug Administration approval for its neurokinin‑1 receptor antagonist tradipitant, marketed as NEREUS™, on December 30 2025. The approval authorizes the drug for the prevention of vomiting caused by motion, marking the first new pharmacologic treatment for motion sickness in more than 40 years and creating a sizable new revenue opportunity for the company.
The decision was based on two Phase III real‑world provocation studies conducted on the Greek islands of Syros and Serifos. In the Motion Syros study, 365 patients received 85 mg of tradipitant and 170 mg of the drug, while 365 patients received placebo. Vomiting incidence fell to 18.3–19.5 % with tradipitant versus 44.3 % with placebo, a risk reduction of 58 %. In Motion Serifos, 316 patients were randomized and vomiting rates dropped to 10.4–18.3 % with tradipitant versus 37.7 % with placebo, a 70 % reduction. The safety profile was favorable; the most common adverse events were somnolence (6 % at 85 mg, 12 % at 170 mg) and fatigue (6 % at 85 mg, 8 % at 170 mg).
The motion‑sickness market is estimated to be worth between $670 million and $700 million in 2025 and is projected to grow to $525 million by 2031. Vanda’s approval positions it to capture a share of this market, which has historically been served by antihistamines and scopolamine patches. The company’s cash reserves of $293.8 million provide a strong runway to commercialize NEREUS™ while pursuing additional indications, notably nausea associated with GLP‑1 weight‑loss drugs and gastroparesis. Analysts project peak U.S. sales of NEREUS™ could exceed $100 million annually, underscoring the commercial upside.
CEO Mihael H. Polymeropoulos said the approval was a “historic milestone” that validates Vanda’s neurokinin‑1 platform and “opens a new chapter” for the company’s pipeline. He highlighted the potential for tradipitant to improve tolerability of GLP‑1 therapies, a market that is expanding rapidly as more patients use these drugs for diabetes and weight management. Vanda is advancing a Phase II study of tradipitant for GLP‑1‑induced nausea, with results expected in Q4 2025.
The approval has already sparked a strong market reaction. Vanda’s shares surged in after‑hours trading on December 30 and continued to climb in pre‑market trading on December 31, reflecting investor enthusiasm for the first new motion‑sickness drug in decades and the company’s broader pipeline prospects. Analysts praised the robust efficacy data and the company’s clear commercialization plan, noting that the approval could serve as a launchpad for future indications.
In summary, the FDA clearance of NEREUS™ represents a pivotal moment for Vanda Pharmaceuticals, providing a new revenue stream, validating its drug platform, and setting the stage for expansion into high‑growth indications such as GLP‑1‑associated nausea. The company’s strong financial position and clear commercialization strategy position it well to capitalize on this opportunity and drive long‑term shareholder value.
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