Clinical study to evaluate Golexanolone in patients with Primary Biliary Cholangitis

Golexanolone is being developed as a novel therapy for patients with PBC who exhibit debilitating central fatigue, i.e., severe fatigue with cognitive impairment.

The ongoing study is a Phase 2 clinical study to further evaluate the safety and tolerability of golexanolone, as well as its potential effect on central fatigue in patients with PBC. The study is led by Professor David Jones at Newcastle University and conducted at approximately 30 clinical sites in 7 countries: United Kingdom, Germany, Greece, Italy, Serbia, Spain, and Turkey.

  • The ongoing study is randomised, double-blind, and placebo-controlled
  • Participants receive 40 mg or 80 mg golexanolone, or placebo (inactive treatment), twice daily for 28 days
  • Outcome measures include evaluation of treatment efficacy on cognitive symptoms, including fatigue and daytime sleepiness

Get in contact

For full information about the study and to find a study clinic close to you, please visit:

For questions about the study, please contact:

Pernilla Sandwall, COO, Umecrine Cognition
[email protected]

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