Vanda says Phase III trial shows HETLIOZ advances sleep onset in delayed sleep-wake phase disorder
Bitget2026/09/29 22:46- 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.
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