Aculys Pharma Announces Positive Results in Japan Phase III Clinical Trial of Pitolisant inPatients with Obstructive Sleep Apnea Syndrome (OSAS)
Aculys has completed the double-blind portion of a Phase 3 trial evaluating the use of pitolisant in Japanese OSAS patients experiencing excessive daytime sleepiness (EDS) currently on Continuous Positive Airway Pressure (CPAP) therapy. In the study, the primary efficacy endpoint was statistically superior to placebo (p=0.007). Further the study confirmed that the safety and tolerability […]
Aculys Pharma: Pitolisant,
a Histamine H3 Receptor Antagonist/Inverse Agonist for Narcolepsy,
Receives Orphan Drug Designation
Tokyo, Japan, December 26, 2024 — Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological and psychiatry conditions, has announced that pitolisant (“this drug”), a histamine H3 receptor antagonist/inverse agonist for narcolepsy, which is currently under development, has received orphan drug designation from the Ministry of Health, Labour […]