Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder
Phase 3positiveHETLIOZPositive
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Summary
Vanda Pharmaceuticals announced positive Phase 3 results for HETLIOZ (tasimelteon) in Delayed Sleep-Wake Phase Disorder, meeting its primary endpoint with sleep onset shifted 37.1 minutes earlier versus placebo. The study showed 60% of HETLIOZ-treated participants achieved at least 30-minute sleep shift improvement compared to 15% in placebo.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
Primary endpoint met: timing of sleep onset shifted 37.1 minutes earlier versus placebo (p=0.022). 60% of HETLIOZ-treated participants shifted sleep at least 30 minutes earlier, compared to 15% of placebo arm.
Importance:8/10
Sentiment:
0.90
Phase 3positive dataHETLIOZtasimelteonDelayed Sleep-Wake Phase Disorder
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Published by PR Newswire Clinical Trials on September 29, 2026 10:45 PM