Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder
Key Highlights
- ➤HETLIOZ (VNDA) shifted sleep onset 37.1 minutes earlier versus placebo (p=0.022)
- ➤60% of HETLIOZ-treated participants advanced sleep timing at least 30 minutes
- ➤Vanda (VNDA) plans FDA discussions and an sNDA for DSWPD approval
- ➤HETLIOZ safety matched its established label, with no new safety signals
Expert Statements
Mihael H. Polymeropoulos, President, CEO and Chairman of the Board of Vanda Pharmaceuticals Inc.
“People with DSWPD often remain undiagnosed and undertreated especially because of the absence of a proven approved treatment”
Mihael H. Polymeropoulos, President, CEO and Chairman of the Board of Vanda Pharmaceuticals Inc.
“This study extends our knowledge of the clinical properties of HETLIOZ(®) as a versatile circadian regulator. We look forward to discussing these data with the FDA and pursuing a new indication for HETLIOZ(®) as the first ever approved treatment for DSWPD.”
Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder PR Newswire
* Study met its primary endpoint: 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 the placebo arm WASHINGTON, Sept. 29, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced positive topline results from its pivotal Phase III study of HETLIOZ(®) (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD). Vanda intends to discuss these data with the U.S. Food and Drug Administration (FDA) and to submit a supplemental New Drug Application (sNDA) seeking approval of HETLIOZ(®) for DSWPD. If approved, HETLIOZ(®) would be the first FDA-approved medicine indicated for this condition.
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