Umecrine Cognition receives Notice of Allowance from the USPTO for treatment of primary biliary cholangitis symptoms with golexanolone
Umecrine Cognition receives Notice of Allowance from the USPTO for treatment of primary biliary cholangitis symptoms with golexanolone
STOCKHOLM – October 21, 2026. Umecrine Cognition today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application protecting a method for the treatment of the primary biliary cholangitis (PBC) symptoms fatigue, as well as cognitive impairment and related PBC symptoms with its proprietary compound golexanolone. Once issued, the patent will provide protection in the US until at least 2042. The company estimates that the US represents approximately 70 percent of the market potential for golexanolone in PBC.
The USPTO has issued a Notice of Allowance for Umecrine Cognition’s patent application protecting fatigue in primary biliary cholangitis (PBC), as well as cognitive impairment, itching and several additional PBC symptoms. The patent is yet a key patent in Umecrine Cognition’s strategic IP portfolio.
Securing method-of-treatment patent protection in the US is an important milestone in Umecrine Cognition’s commercial strategy in PBC. A patent protecting the treatment of PBC-related symptoms with golexanolone provides a competitive advantage in the company’s most important market and significantly de-risks the planned commercialization of golexanolone.
Central fatigue, PBC-related fatigue frequently associated with cognitive impairment, is the symptom PBC patients rank as most burdensome, and no approved therapy currently exists. Golexanolone is a first-in-class GABAA receptor-modulating steroid antagonist currently being evaluated in the Phase 1b/2a study UCAB-CT-05 in PBC patients with clinically significant fatigue and cognitive symptoms. The last patient completed the final follow-up visit in September 2026, and results are expected early November 2026.
“This Notice of Allowance is an important milestone for our commercial strategy in PBC. We estimate that the US represents approximately 70 percent of the market potential for golexanolone in this indication, and securing a method-of-use patent there gives us strong competitive advantages and significantly de-risks our path towards commercialization,” comments Dr. Viktor Drvota, CEO of Umecrine Cognition.
For further information, please contact:
Viktor Drvota, CEO, Umecrine Cognition AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@umecrine.se
About the Phase 1b/2a study UCAB-CT-05
UCAB-CT-05 is a randomized, double-blind, placebo-controlled, two-part Phase 1b/2a study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of golexanolone in patients with primary biliary cholangitis (PBC) who experience clinically significant fatigue and cognitive symptoms. Part A (5 days, 40 mg twice daily) assessed safety and pharmacokinetics, while Part B (28 days, 40 mg or 80 mg twice daily) is evaluating efficacy using validated patient-reported and clinical measures. Key efficacy assessments include changes from baseline in the PBC-40 domains (cognition, fatigue, itch, social, emotional, and general symptoms), EQ-5D-3L, Epworth Sleepiness Scale, a cognitive test battery (PHES, RAVLT, D-KEFS), and the Clinical Global Impression of Change specific for PBC (CGI-C-PBC™). The study is conducted across more than 30 sites in Europe and Turkey.
About Umecrine Cognition
Umecrine Cognition AB is developing a completely new class of drugs for the treatment of symptoms in the central nervous system related to chronic neuroinflammation – a devastating brain distortion that can lead to severely impaired cognition and fatigue. Chronic neuroinflammation can occur as a result of a number of underlying conditions, including a range of liver diseases as well as neurodegenerative diseases, such as Parkinson’s disease. Results from an internationally acclaimed Phase 2 clinical study indicate that the company's most advanced drug candidate, the GABAA receptor-modulating steroid antagonist golexanolone, normalizes brain signaling and improves cognition and alertness in patients with hepatic encephalopathy. A Phase 2 study is currently ongoing in patients with primary biliary cholangitis. Further, based on intriguing preclinical data, the company is considering pursuing the development of golexanolone in patients with Parkinson’s disease. For more information, visit www.umecrinecognition.com.