Aculys Pharma Acquired by Viatris
Tokyo, Japan, October 16, 2025 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, today announced that Viatris Inc. (Nasdaq: VTRS) has completed its acquisition of Aculys. Guided by a core philosophy of “Catalyst to Access” and a core mission to address the challenges of drug […]
Aculys Pharma Receives Marketing Approval for Spydia® Nasal Spray in Japan, an Immediate-Use Medication for Epileptic Seizures
Tokyo, Japan, June 24, 2025 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions, announced that it has received marketing approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan for “Spydia® Nasal Spray 5 mg, 7.5 mg, and 10 mg” (generic name: diazepam) […]
Aculys Pharma Signs 4.4 Billion Yen Series C Funding Round Agreement
The additional funding will be used to prepare for regulatory approval and commercialization of diazepam nasal spray and pitolisant Tokyo, Japan, March 24, 2025 – Aculys Pharma, Inc. (“Aculys”), a clinical stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics in the fields of neurological and psychiatry, announced that it has […]
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 […]