FDA approves Vanda's NEREUS (tradipitant) for motion sickness prevention; first new drug in 40+ years

Vanda Pharmaceuticals Inc.

FDA approved NEREUS (tradipitant) on Dec 30, 2025 for prevention of vomiting induced by motion; first new drug class for motion sickness in >40 years.
Pivotal Phase 3 trials: vomiting incidence 18.3-19.5% with NEREUS vs 44.3% placebo (Motion Syros, p<0.0001); 10.4-18.3% vs 37.7% (Motion Serifos, p≤0.0014).
Vanda plans to launch NEREUS in coming months; also advancing tradipitant for gastroparesis and GLP-1 agonist-induced nausea.
Mechanism: NK-1 receptor antagonist, targets substance P pathway underlying nausea/vomiting.

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