Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
golexanolone · 1 trial · 1 indication
Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 28
Frequency, intensity, and seriousness of adverse events (AEs)
| Arm | Type | Description |
|---|---|---|
| Part B: Treatment arm 1 (golexanolone 40 mg) | EXPERIMENTAL | 40 mg golexanolone BID |
| Part B: Treatment arm 2 (golexanolone 80 mg) | EXPERIMENTAL | 80 mg golexanolone BID |
| Placebo | PLACEBO_COMPARATOR | Part B: Placebo BID |
| Part A: Golexanolone | EXPERIMENTAL | 40 mg golexanolone BID |
| Part A: Placebo | PLACEBO_COMPARATOR | Placebo BID |
| Name | Type | Description |
|---|---|---|
| golexanolone | DRUG | soft gelatin capsules, oral dosage twice per day for up to 28 days |
| Placebo | DRUG | soft gelatin capsules, oral dosage twice a day for up to 28 days |
Inclusion Criteria: * Male and female subjects age ≥ 18 years * Diagnosis of PBC based on the presence of ≥2 of 3 key disease characteristics * Clinically significant fatigue defined for the purposes of this study as a PBC-40 fatigue domain score of ≥29 at screening * Clinically significant cogniti...
Golexanolone is an investigational small molecule being developed for Primary Biliary Cholangitis (PBC), specifically for patients with fatigue and cognitive dysfunction. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Golexanolone is being developed by Cognition Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker CGTX. The company is conducting clinical trials to evaluate the drug's effects in patients with Primary Biliary Cholangitis.
Golexanolone is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The ongoing Phase 1 trial is recruiting participants to study the drug's safety and effects in adults with Primary Biliary Cholangitis.
Golexanolone is being studied in a Phase 1 clinical trial registered as NCT07304843. This two-part study investigates the effects of two doses of golexanolone in adults with Primary Biliary Cholangitis who experience fatigue and cognitive dysfunction. The trial is currently recruiting participants across multiple countries.
Yes, the Phase 1 clinical trial of golexanolone is randomized, double-blind, and placebo-controlled. The study plans to enroll 84 participants and includes biomarker selection. It is currently recruiting patients in Germany, Greece, Hungary, Italy, Serbia, Spain, Turkey, and the United Kingdom.