Handok said it would conduct a global phase-3 clinical trial to test Nemorexant, a follow-up treatment of insomnia drug Zolpidem, in Korea. The Ministry of Food and Drug Safety on Friday approved Handok’s plan for the trial, “ACT-541468A (Nemorexant).”
The study will be a multicenter, double-blind, randomized, placebo-controlled, and parallel test to assess the efficacy and safety of ACT-541468A, in adults and the elderly with a sleep disorder.
The trial will include polysomnography (PSG), a type of sleep study. Participating hospitals include Keimyung University Dongsan Medical Center, Seoul National University Hospital, Severance Hospital, Catholic University of Korea St. Vincent's Hospital, Bundang Seoul National University Hospital, Konkuk University Hospital, and Kyung Hee University Medical Center.
Nemorexant is the first dual orexin receptor antagonist (DORA). Orexin, a hormone secreted from the hypothalamus of the brain, regulates appetite and wakefulness. Hunger causes the secretion of orexin. The hormone also raises attention and arousal.
Nemorexant binds to orexin receptors, inhibiting the activity of the hormone and inducing normal sleep. Idorsia, which was spun off from Actelion in 2017, is conducting the global phase-3 on the sleep drug.
Handok only carries out the local study and does not have the sales rights.
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