The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
MAY 4 2026
APPROVED · 148 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's perception of motion doesn't match what the body senses, causing distressing symptoms like nausea, vomiting, and dizziness. Nereus (tradipitant) is an oral drug that works by blocking a specific receptor in the brain called NK1, which is involved in triggering nausea. This blockade could help prevent or reduce the intense nausea associated with motion sickness for travelers.

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)