EISAI TO BEGIN ENROLLING PHASE 2 STUDY IN PATIENTS WITH NARCOLEPSY
NUTLEY, N.J., March 26, 2026 /PRNewswire/ -- Eisai Inc. announced today that screening for global Study E2086-G000-202 (Study 202) to assess the efficacy, safety and tolerability of E2086, a novel selective orexin-2 receptor, is now registered on ClinicalTrials.gov as NCT07493265. Study sites are also planned for Canada, China, Europe, Japan, and South Korea.
Study 202 is a three-period, dose escalation study in adult patients with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2). Three dose strengths of E2086 per NT1 or NT2 participants will be assessed compared with placebo using objective and patient-reported measures of wake promotion.
Narcolepsy is a sleep disorder resulting from disorganization of the sleep/wakefulness cycle. In patients with NT1, excessive daytime sleepiness and cataplexy (acute episodes of loss of muscle tone) are reported in association with low levels of the neurotransmitter orexin. In patients with NT2, excessive daytime sleepiness occurs, but without reports of cataplexy.
As a selective orexin-2 receptor agonist, E2086 is hypothesized to compensate for the loss of orexin in patients with narcolepsy. In nonclinical studies, E2086 was shown to increase wake time and decrease cataplexy-like episodes in narcolepsy model mice and to prolong wakefulness in wild-type mice.1 In a recently completed proof-of-mechanism study in patients with NT1, compared with placebo and an existing treatment (modafinil), E2086 provided statistically significant and clinically meaningful increases in wake time as assessed by the objective maintenance of wakefulness test and by the patient-reported Karolinska sleepiness scale.2
For information about this study, please contact Eisai Medical Information at https://www.eisaimedicalinformation.com/ or 1-888-274-2378 (Monday through Friday 8:30 AM – 5:00 PM EST, excluding holidays).
About E2086
E2086 is Eisai's in-house discovered novel selective orexin 2 receptor agonist. Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Individuals with a deficiency of orexin demonstrate excessive daytime sleepiness (EDS), as exemplified by patients with narcolepsy Type 1, demonstrate a loss of orexinergic neurons, and low cerebrospinal fluid (CSF) orexin levels. E2086 has the potential to improve patients' symptoms by enhancing orexin receptor activity.
About Eisai Inc.
Eisai Inc. is a human health care (hhc) company dedicated to improving the lives of people affected by cancer, Alzheimer's disease and other neurodegenerative conditions. Everything we do is guided by the simple principle that patients and their families come first, and we have a responsibility to listen to and learn from them.
Our hhc mission is the shared purpose that connects us to those we serve. It creates a network of powerful relationships that enable us to identify, understand and address unmet needs and healthcare disparities as we work towards achieving societal good.
Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. Our U.S. operations include discovery, research and development; manufacturing; global supply and logistics; and commercial activities.
To learn more, please visit us at https://us.eisai.com and connect with us on X and LinkedIn. For more information on our research, follow our dedicated neurology (LinkedIn and X) and oncology (LinkedIn and X) pages.
1 Hatanaka K, et al. Discovery of a Novel Orally Available Selective Orexin 2 receptor Agonist, E2086, as a Therapeutic Drug for Narcolepsy and Other Hypersomnia Disorders. Presented at the World Sleep Congress, Rome, Italy, 11-16 March 2022. | |||||
SOURCE Eisai Inc.
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