---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-25-059155"
form_type: "8-K"
ticker: "VNDA"
cik: "0001347178"
company_name: "Vanda Pharmaceuticals Inc."
filed_at: "2025-12-31T23:59:59+00:00"
generated_at: "2026-05-16T11:53:27.576955+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001628280-25-059155
- form_type: 8-K
- ticker: VNDA
- cik: 0001347178
- company_name: Vanda Pharmaceuticals Inc.
- filed_at: 2025-12-31T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347178/000162828025059155/0001628280-25-059155-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347178/000162828025059155/vnda-20251230.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-25-059155
- JSON: https://secwatch.observer/filing/0001628280-25-059155.json
- Plain text: https://secwatch.observer/filing/0001628280-25-059155.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.