FDA

Nereus approved for prevention of motion sickness

January 13, 2026

Brand name: Nereus

Generic name: tradipitant

Manufacturer: Vanda Pharmaceuticals

Approval date: December 30, 2025

FDA approved Nereus (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion.

Efficacy

Approval was supported by two randomized, double-blind, placebo-controlled trials: Motion Syros (NCT0432766) and Motion Serifos (NCT05903924). Participants were randomized 1:1:1 to receive a single oral dose of Nereus 85 mg, 170 mg, or placebo about 60 minutes before a 2 to 5-hour boat trip. Subjects with chronic nausea were excluded, and antiemetic use was prohibited. Medication was taken without food.

Both studies enrolled adults (mean age, 48 years; 62% female). Trips lasted 2 to 4.4 hours with peak wave heights of 0.3 to 2.5 meters. Primary endpoint was vomiting incidence, assessed every 30 minutes via a single-item questionnaire.

In Motion Syros (N = 365), vomiting occurred in 18% to 20% of Nereus-treated participants vs. 44% with placebo. In Motion Serifos (N = 316), rates were 10% to 18% vs. 38% with placebo, representing risk reductions of more than 50% to 70%.

Safety

Common adverse reactions occurring in ≥5% of patients included somnolence, headache, and fatigue.

Recommended dose

The recommended dosage of Nereus is 85 mg or 170 mg as a single oral dose approximately 60 minutes before an event expected to cause vomiting induced by motion. The maximum dosage in a 24-hour period is a single dose of 85 mg or 170 mg. The medication should be administered on an empty stomach, at least 1 hour prior to or 2 hours after a full meal.

Sources:

Nereus (tradipitant) [package insert]. Vanda Pharmaceuticals. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220152Orig1s000lbl.pdf Revised December 2025. Accessed January 12, 2026.

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 [News release]. 2025. https://vandapharmaceuticalsinc.gcs-web.com/node/16681/pdf