The multicenter trial, known as Study 3201, enrolled 546 adults between the ages of 18 and 65 across 30 U.S. clinical sites. Participants were subjected to the Trier Social Stress Test, a rigorous protocol designed to induce anxiety through public speaking and interview simulations. While the drug was found to be safe and well-tolerated, it failed to outperform a placebo in reducing distress levels among female participants or the broader study population.

These findings represent a significant setback for the company, as they contradict data from an earlier Phase II trial that had suggested the molecule could effectively mitigate performance-related anxiety. Mihael H. Polymeropoulos, CEO of Vanda Pharmaceuticals, expressed disappointment regarding the lack of confirmation for the earlier results. The company is now conducting a comprehensive analysis of the full dataset to determine the future of the program.