Drugs / golexanolone
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07304843 | Apr 2023 → Sep 2026 overdue | primary biliary cholangitis | Umecrine Cognition AB | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2025-11-19 | Umecrine Cognition AB | Results Umecrine Cognition publishes review highlighting the therapeutic potential of golexanolone in treating neuroinflammatory disorders umecrinecognition.com ↗
The article highlights robust preclinical and early clinical data showing that golexanolone reduces neuroinflammation and restores normal brain function through a unique dual mechanism. |
| 2025-11-17 | Umecrine Cognition AB | Results Umecrine Cognition reports early golexanolone treatment yields sustained benefit in a preclinical model of Parkinson’s disease umecrinecognition.com ↗
Umecrine Cognition AB today announced publication in Neuropharmacology of findings which show that early treatment with golexanolone provides sustained improvements of both motor and non-motor symptoms in a model of Parkinson’s disease (PD). |
| 2025-09-04 | Umecrine Cognition AB | Results Umecrine Cognition publishes data showing sustained reversal of neuroinflammation in Parkinson’s disease model umecrinecognition.com ↗
The new data show a sustained therapeutic effect of golexanolone in a preclinical model, supporting the use of golexanolone as a chronic treatment in Parkinson’s disease. |
| 2025-04-01 | Umecrine Cognition AB | Results Umecrine Cognition presents nonclinical data at AD/PD™ 2025 showing that golexanolone reverses dopamine loss and sustains improvements of Parkinsonian symptoms umecrinecognition.com ↗
Golexanolone completely reversed excessive glutamate activity, restoring balance in the brain. |
| 2024-11-18 | Umecrine Cognition AB | Results Umecrine Cognition presents positive interim data from ongoing Phase 1b/2a study with golexanolone at the AASLD Liver Meeting in San Diego umecrinecognition.com ↗
The preliminary results show that golexanolone achieved drug exposure levels that correlate to clinical treatment doses and was well-tolerated as no serious adverse effects were observed. |
| 2024-10-17 | Umecrine Cognition AB | Results Umecrine Cognition attends INBC 2024 to present new preclinical data showing conserved dopamine signaling in Parkinson’s disease umecrinecognition.com ↗
The results show that treatment with golexanolone significantly reduced (p<0.05) the decrease of a dopamine-producing enzyme (tyrosine hydroxylase, TH) in the brain, returning dopamine to normal levels, compared to vehicle treatment (p<0.05). |
| 2024-06-28 | Umecrine Cognition AB | Results Umecrine Cognition publishes new nonclinical data for golexanolone in Parkinson’s disease that will be presented at the FENS Forum 2024 umecrinecognition.com ↗
Umecrine Cognition today announces that the company has published new nonclinical data in the journal Frontiers in Aging Neuroscience, showing the beneficial effects of golexanolone on both non-motor and motor symptoms in a preclinical model of Parkinson’s disease. |
| 2024-03-22 | Umecrine Cognition AB | Results Umecrine Cognition’s Phase 1b/2 study of golexanolone in Primary Biliary Cholangitis progresses to Part B following positive safety review umecrinecognition.com ↗
Part A interim data show that golexanolone exhibits a favorable safety and tolerability profile in the study population. |
| 2024-03-06 | Umecrine Cognition AB | Results Umecrine Cognition presents nonclinical data at AD/PD™ 2024 further elucidating golexanolone’s mode-of-action in Parkinson’s disease umecrinecognition.com ↗
In the study to be presented at AD/PD™ 2024, golexanolone improved both motor symptoms and non-motor symptoms, including fatigue, anxiety and depression (p<0.05). |
| 2023-11-28 | Umecrine Cognition AB | Results Umecrine Cognition presents preclinical results showing significant decreases in PBC-like symptomology and neuroinflammation umecrinecognition.com ↗
Stockholm, November 28, 2023 – Umecrine Cognition AB today announced positive preclinical results that indicate normalizing effects of the clinical drug candidate golexanolone on PBC-like symptomology including cognitive symptoms, such as fatigue, motor impairments, neuroinflammation, and neural signaling. |
| 2023-07-05 | Umecrine Cognition AB | Results Umecrine Cognition presents data at World Parkinson Congress showing positive effects of golexanolone in a preclinical model of Parkinson’s disease umecrinecognition.com ↗
The results show that the company’s clinical drug candidate golexanolone reverses fatigue, anxiety, depression, and some cognitive and motor alterations in the Parkinson’s disease model. |
| 2023-06-07 | Umecrine Cognition AB | Results Umecrine Cognition presents new preclinical data that elucidates the mechanism-of-action of golexanolone in cholestatic liver disease umecrinecognition.com ↗
The results from the preclinical study showed that golexanolone reversed the increase of several pro-inflammatory interleukins and reversed specific alterations in GABAergic neurotransmission in the cerebellum. |
| 2023-01-17 | Umecrine Cognition AB | Regulatory Umecrine Cognition announces Orphan Drug Designation granted by FDA for golexanolone umecrinecognition.com ↗
STOCKHOLM – January 17, 2023. Umecrine Cognition AB today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company’s proprietary compound golexanolone, a novel neurosteroid-based drug candidate for the treatment of Primary Biliary Cholangitis (PBC). |
| 2023-01-03 | Umecrine Cognition AB | Results Umecrine Cognition presents data showing improved symptoms in a model of Parkinson’s disease following treatment with golexanolone umecrinecognition.com ↗
Umecrine Cognition AB today announced results showing that the company’s clinical drug candidate golexanolone reverses fatigue, anxiety, depression, and some cognitive and motor alterations in a preclinical model of Parkinson’s disease. |
| 2022-09-28 | Umecrine Cognition AB | Results Umecrine Cognition presents data showing reversal of fatigue in a model of PBC following treatment with golexanolone umecrinecognition.com ↗
Umecrine Cognition AB today announced results showing that the company’s clinical drug candidate golexanolone largely eliminated fatigue in a preclinical disease model of cholestasis. |
| 2022-05-19 | Umecrine Cognition AB | Regulatory Umecrine Cognition submits application for Phase 2 clinical trial of golexanolone umecrinecognition.com ↗
Umecrine Cognition AB today announces that the company has submitted a clinical trial application (CTA) for a Phase 2 study of golexanolone in patients with primary biliary cholangitis, PBC. |
| 2022-02-21 | Umecrine Cognition AB | Results Umecrine Cognition to present preclinical results showing beneficial effects of golexanolone on neuroinflammation and movement dysfunction umecrinecognition.com ↗
Novel findings reveal that treatment with the company’s most advanced drug candidate golexanolone is linked to reduction in neuroinflammation and improvements in motor impairment, symptoms that arise as a result of chronic liver disorders and other similar pathologies. |
| 2022-01-10 | Umecrine Cognition AB | Results Umecrine Cognition presents data showing a reduction of neuroinflammation following treatment with golexanolone umecrinecognition.com ↗
Umecrine Cognition AB today announced nonclinical results showing that its clinical drug candidate golexanolone exerts a normalizing effect on neuroinflammation in the cerebellum, resulting in reversal of disease-associated motor disturbances. |
| 2021-11-03 | Umecrine Cognition AB | Results Umecrine Cognition presents data supporting a new predictive biomarker in patients with primary biliary cholangitis at the AASLD International Liver Meeting 2021 umecrinecognition.com ↗
Umecrine Cognition AB today announces new scientific results for its drug candidate golexanolone, linking the drug target allopregnanolone to cognitive symptoms in patients with primary biliary cholangitis. |
| 2021-04-21 | Umecrine Cognition AB | Results Umecrine Cognition announces publication in the Journal of Hepatology of the results of a pilot study of golexanolone in patients with hepatic encephalopathy umecrinecognition.com ↗
STOCKHOLM. Umecrine Cognition AB today announced that the Journal of Hepatology has published safety, pharmacokinetic, and preliminary efficacy results from the pilot Phase 2a study of golexanolone in patients with cirrhosis and covert hepatic encephalopathy (HE). |
| 2020-09-02 | Umecrine Cognition AB | Results Umecrine Cognition to present clinical Phase 2a results at AASLD International Liver Meeting umecrinecognition.com ↗
This study is the first to demonstrate improvement in neuropsychometric performance in patients with cirrhosis through selective inhibition of the synergistic allopregnanolone pathway |
| 2020-05-08 | Umecrine Cognition AB | Results Umecrine Cognition announces positive additional endpoint data from a phase 2a study with golexanolone in hepatic encephalopathy umecrinecognition.com ↗
These complementary prespecified endpoint data build upon the company’s topline data from the UCAB-CT-02 study announced in April 2020, demonstrating favorable safety and tolerability profile of golexanolone in patients with liver cirrhosis and mild hepatic encephalopathy. |
| 2020-04-03 | Umecrine Cognition AB | Results Umecrine Cognition announces top-line results from its phase 2a study with golexanolone in hepatic encephalopathy umecrinecognition.com ↗ |
| 2019-12-20 | Umecrine Cognition AB | Regulatory Umecrine Cognition announces a Notice of Allowance from USPTO for a patent protecting a pharmaceutical formulation of its proprietary lead compound golexanolone umecrinecognition.com ↗
Umecrine Cognition AB, a Karolinska Development (NASDAQ Stockholm: KDEV) portfolio company, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent protecting a pharmaceutical formulation of its lead candidate drug golexanolone, currently in clinical Phase 2a development for hepatic encephalopathy. |
All press releases naming this drug 40 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | golexanolone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07304843 ↗ |
| Route | Oral | “soft gelatin capsules, oral dosage twice per day for up to 28 days” NCT07304843 ↗ |