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MAY 4 2026
APPROVED · 88 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 where the brain receives conflicting signals about movement, triggering symptoms like nausea, vomiting, and dizziness. Nereus (tradipitant) is an oral medicine that blocks a specific brain receptor (NK1) involved in transmitting nausea signals. By calming this pathway, it could help prevent the debilitating nausea that disrupts travel for those affected.

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)