Vanda's HETLIOZ Hits Phase III Goal in Sleep Disorder Trial
Image
Washington – September 30, 2026 -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) reported positive topline results from a pivotal Phase III study of HETLIOZ® (tasimelteon) 20 mg in adults with Delayed Sleep-Wake Phase Disorder (DSWPD), setting up a supplemental New Drug Application (sNDA) filing with the U.S. Food and Drug Administration (FDA).
Trial meets primary endpoint with statistically significant sleep-timing shift
The study, VP-VEC-162-3502 (NCT04652882), shifted sleep onset 42.5 minutes earlier in the HETLIOZ® arm (n=20) versus 5.4 minutes on placebo (n=20), a 37.1-minute difference (p=0.022). In an exploratory responder analysis, 60% of tasimelteon-treated participants (12/20) advanced sleep onset by at least 30 minutes, compared with 15% on placebo (3/20) (p=0.008).