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 […]
Aculys Pharma Delivers Positive Results in Domestic Phase III Clinical Trial of Pitolisant for Narcolepsy Patients
Aculys completed the double-blind portion of a Phase 3 trial in Japan for the use of pitolisant in narcolepsy patients. In the study, the primary efficacy endpoint was achieved, and the study confirmed that the safety and tolerability of pitolisant were comparable to those observed in overseas clinical trials. Based on the study results, Aculys […]
Aculys Pharma Files New Drug Application for Diazepam Nasal Spray in Japan: An Antiepileptic Drug for the Treatment of Epileptic Seizures
Tokyo, Japan, September 2, 2024 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced that it has submitted a New Drug Application to the Ministry of Health, Labour and Welfare (MHLW) for diazepam nasal spray, an antiepileptic drug being developed in Japan for the treatment of […]
Aculys Pharma Completes Patient Enrollment for Phase 3 Clinical Trial on Pitolisant in Patients with Narcolepsy
Tokyo, Japan, July 22, 2024 — Aculys Pharma, Inc. (“Aculys”), a clinical-stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that it has finished enrolling patients for the domestic Phase 3 clinical trial on the histamine H3 receptor antagonist/inverse agonist pitolisant in patients with narcolepsy. Hidemasa Tanigaki, Chief Executive Officer of […]
Aculys Pharma Announces Appointment of Hidemasa Tanigaki as New CEO
～Hidemasa’s appointment bolsters Aculys’ position as a leader in the field of CNS in Japan and Asia～ Aculys Pharma, Inc. (“Aculys”), a clinical-stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announces the appointment of Hidemasa Tanigaki as Chief Executive Officer and Representative Director, effective March 29th. Hidemasa has an outstanding track […]
Aculys Pharma receives orphan drug designation for a diazepam nasal spray: an antiepileptic drug for epileptic seizures
Tokyo, Japan, November 24, 2023 — Aculys Pharma, Inc., a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that a diazepam nasal spray (compound development code: NRL-1), an antiepileptic drug currently under development for the treatment of epileptic seizures, has been designated as an orphan drug by the Ministry of Health, Labour […]
Aculys Pharma Announces Leadership Change
Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that Kazunari Tsunaba will be leaving his position as Chief Executive Officer. Takeshi Takahashi, a co-founder, and a member of the Board will be acting as interim Chief Executive Officer effective immediately. Mr. Takahashi will lead […]
Aculys Pharma delivers positive Phase 3 clinical study interim analysis result of a diazepam nasal spray: an antiepileptic drug for the treatment of epileptic seizures
These results are from Japan’s first domestic Phase 3 clinical trial of an intranasally administered antiepileptic drug for Japanese patients aged 6 to 17 for the treatment of status epilepticus or epileptic seizures that may lead to status epilepticus. The primary efficacy endpoint was met in a pre-specified interim analysis, and the drug was found […]
Aculys Pharma and Medical Note enter into a partnership to raise awareness on sleep disorders
Goal to build a “sleep ecosystem” to resolve sleep-related social issues in Japan, which cause an economic loss of approximately 15 trillion yen annually Tokyo, Japan, May 23, 2023 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, and MedicalNote, Inc. (“Medical Note”), a leading online healthcare […]