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MAY 4 2026
APPROVED · 30 DAYS AGO

Vanda Pharmaceuticals Nereus (tradipitant) $VNDA

for motion sickness

NDA · Standard Review

FDA approved Nereus (tradipitant) for motion sickness on May 4, 2026 — the first new pharmacologic treatment for motion sickness in over 40 years. Distinct program from Vanda's tradipitant gastroparesis NDA which received a CRL earlier.

About

Motion sickness is a condition triggered by a mismatch between perceived and actual movement, causing nausea, vomiting, dizziness, and fatigue. Nereus (tradipitant) is an oral drug that blocks the NK1 receptor, a protein involved in signaling nausea and vomiting in the brain. By targeting this pathway, Nereus may help reduce the uncomfortable symptoms of motion sickness during travel.

Pivotal trial

NCT04327661 Phase 3 completed NCT04327661

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel

Source: ClinicalTrials.gov

Also in development

PDUFA history

  • JUN 4 2025 shifted to DEC 4 2025 (FDA major-amendment extension; announced FEB 15 2025)