WASHINGTON – October 28, 2026 -- Vanda Pharmaceuticals (Nasdaq: VNDA) reported that NEREUS (tradipitant) cut the incidence of semaglutide-induced vomiting by 27% in a Phase III trial. Vomiting occurred in 43.0% of treated participants (61/142) versus 58.5% on placebo (96/164), with a p-value of 0.006.
The company plans to discuss the data with the U.S. Food and Drug Administration (FDA). It intends to file a supplemental New Drug Application (sNDA) for preventing vomiting associated with GLP-1 receptor agonist therapy.
NEREUS lowers combined vomiting and severe nausea by 35% in key secondary endpoint
The key secondary endpoint combined any vomiting with worst nausea of 3 or higher. It occurred in 33.1% of participants on NEREUS (47/142) versus 50.6% on placebo (83/164), a 35% relative reduction (p=0.002).
Post hoc analyses show 81% fewer cases of extreme vomiting
Frequent multi-day vomiting, defined as more than two episodes on more than one day, affected 6.3% of the NEREUS group (9/142) versus 15.9% on placebo (26/164). That is a 60% relative reduction (p=0.008).
Extreme vomiting, defined as more than 10 total episodes, affected 2.8% (4/142) versus 14.6% (24/164), an 81% relative reduction (p=0.0003). Vanda states both analyses are post hoc and supportive only. The Phase II study showed a similar reduction of roughly 80% in extreme vomiting.
Most vomiting occurs by Day 2, narrowing the prevention window
Almost all vomiting episodes in both arms occurred by Day 2. Rates peaked on Day 1, and the gap between NEREUS and placebo was widest on Days 1 and 2. Vanda concludes that dosing before initiation or dose escalation, and in the first days afterward, is the most effective window.
Trial used a single 1 mg semaglutide dose without titration
Participants received one 1 mg dose of semaglutide without the gradual titration used in clinical practice, a high-emetogenic stress test. A pooled Phase II and Phase III exposure-response analysis showed the reduction in vomiting probability stayed stable across the observed semaglutide concentration range. It showed no weaker effect at lower exposures, which Vanda cites to support extrapolating to real-world dosing.
NEREUS is an oral neurokinin-1 (NK-1) receptor antagonist that blocks substance P signaling in the area postrema and nucleus tractus solitarius. Vanda expects it to apply across all available GLP-1 receptor agonists. Safety was consistent with earlier studies, with no new signals.
Vanda targets a GLP-1 market above $50 billion where discontinuation is high
The company cites real-world studies showing roughly half of patients discontinue GLP-1 therapy within one year, with gastrointestinal side effects among the leading reasons. It puts the global GLP-1 receptor agonist market above $50 billion.
CEO Mihael Polymeropoulos said the program's results could offer significant benefit to the millions of people seeking or using GLP-1 therapies.
NEREUS was approved in December 2025 for preventing motion-induced vomiting. Vanda's forward-looking statements flag the FDA's willingness to meet on the proposed sNDA during 2027 as a key uncertainty. They also list its ability to use the currently approved product for this indication and the capacity of its commercial infrastructure.