Vanda plans supplemental NDA filing for Hetlioz after Phase III win
Vanda said Phase III met its primary endpoint in delayed sleep-wake phase disorder, shifting sleep onset 37.1 minutes earlier than placebo (p=0.022), and plans to meet FDA and file an sNDA seeking a new indication.
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10:46:48 PM UTC
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Vanda reported positive topline Phase III results for HETLIOZ in delayed sleep-wake phase disorder; results were announced today. The trial showed patients on HETLIOZ were more likely to shift sleep earlier than those on placebo. Vanda plans to discuss the data with the FDA, then file a supplemental NDA to add the new indication. If cleared, HETLIOZ would become the first FDA-indicated drug for delayed sleep-wake phase disorder. Safety over the controlled treatment period was consistent with the existing HETLIOZ label, with no new safety issues flagged. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vanda Pharmaceuticals Inc. published the original content used to generate this news brief via (Ref. ID: PH59973) on September 29, 2026, and is solely responsible for the information contained therein. (C)