Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) released results from its Phase 3 trial evaluating Nereus, an oral therapy aimed at preventing vomiting associated with GLP-1 receptor agonist treatments.
The company seeks to address a critical tolerability hurdle in an expanding global market exceeding $50 billion.
• Vanda Pharmaceuticals stock is trading at depressed levels. Where are VNDA shares going?
Based on combined data from Phase 2 and Phase 3 studies, Vanda plans to discuss the findings with the U.S. Food and Drug Administration.
The company intends to submit a supplemental New Drug Application to expand the label for Nereus, known generically as tradipitant.
Regulators previously approved the oral neurokinin-1 receptor antagonist in December 2025 for preventing motion-induced vomiting.
Trial Demonstrates Significant Symptom Reduction
The Phase 3 trial assessed tradipitant against a placebo in patients receiving GLP-1 receptor agonists.
Patients receiving Nereus achieved a 27% relative reduction in overall vomiting incidence, with 43% of treated participants vomiting compared to 58.5% in the placebo cohort.
The study also met its key secondary endpoint, producing a 35% relative reduction in instances where patients experienced vomiting alongside severe nausea.
Supportive post-hoc analyses highlighted sharp decreases in higher-intensity vomiting patterns.
Frequent vomiting fell 60%, occurring in 6.3% of Nereus patients versus 15.9% on placebo.
Extreme vomiting plunged 81%, affecting 2.8% of the Nereus group compared to 14.6% on placebo, echoing an 80% reduction observed in Phase 2 testing.
Addressing The GLP-1 Tolerability Challenge
The findings underscored the importance of treatment timing. Most vomiting episodes occurred by Day 2, and vomiting rates reached their peak on Day 1.
The efficacy separation between Nereus and placebo proved widest during these first 48 hours, demonstrating that preventative dosing prior to initiating or escalating GLP-1 therapy delivers the most substantial benefit.
Gastrointestinal side effects drive roughly half of patients to discontinue GLP-1 therapies within one year.
By improving tolerability, Nereus could help more patients initiate and maintain treatment. Vanda confirmed that the drug maintained a favorable safety profile consistent with earlier studies and produced no new safety signals.
VNDA Price Action: Vanda Pharmaceuticals shares were down 0.63% at $3.92 at the time of publication on Tuesday, according to Benzinga Pro data.
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