Acadia Pharmaceuticals Inc. announced on September 24, 2025, top-line results from the Phase 3 COMPASS PWS trial evaluating intranasal carbetocin (ACP-101) for hyperphagia in Prader-Willi syndrome (PWS). The trial did not demonstrate a statistically significant improvement over placebo on its primary endpoint.
The primary endpoint was the change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). Additionally, ACP-101 did not meet key secondary endpoints in the study, indicating a lack of efficacy in this late-stage trial.
This trial failure represents a significant setback for Acadia's pipeline, as ACP-101 was a key late-stage asset. The company will discontinue the development of intranasal carbetocin for Prader-Willi syndrome, resulting in the loss of a potential future revenue stream and substantial R&D investment.
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