Umecrine Cognition AB

Umecrine Cognition AB is a Swedish clinical-stage pharmaceutical company based in Solna, Sweden. The company is developing a novel class of drugs known as GABAA receptor-modulating steroid antagonists (GAMSAs), which are designed to treat neurological disorders in the brain caused by neuroinflammation. This condition can arise from a wide range of underlying diseases and can lead to severely reduced cognition and alertness. Umecrine Cognition's scientific focus is on this GAMSA mechanism, and its lead product candidate is golexanolone, a novel small molecule GABAA receptor-modulating steroid antagonist in development for the treatment of neurological disorders caused by overactivation of GABA-A receptors by the neurosteroid allopregnanolone. The company's most advanced drug candidate, golexanolone, has produced results from an internationally acclaimed clinical Phase 2 study indicating that it improves brain signaling, cognition, and alertness in patients with the liver disease hepatic encephalopathy. The continued development of golexanolone is initially focused on patient groups whose symptoms have arisen as a result of chronic liver diseases, but its mechanism of action is also considered relevant in a number of other indication areas, including neurodegenerative diseases such as Parkinson's disease. As of 2026, golexanolone is in Phase 2 clinical development for the treatment of patients with primary biliary cholangitis (PBC) exhibiting fatigue with cognitive impairment, also known as central fatigue. The company is also evaluating other disorders that affect patients' ability to think and reason, including memory, attention, language, and problem-solving, as well as neurodegenerative disorders such as Parkinson's disease. Approximately 190,000 patients are diagnosed with PBC in the world's seven largest pharmaceutical markets (US, UK, France, Germany, Italy, Spain, and Japan), with an estimated 100,000 patients in the US alone. The initial target population consists of PBC patients experiencing debilitating central fatigue, approximately one-third of all patients, translating to about 63,000 patients in the 7MM. In 2021, the global PBC treatment market was valued at USD 584 million and is projected to reach USD 3 billion by 2027. Currently approved drugs slow PBC disease progression but do not relieve patients from fatigue or cognitive impairment. Golexanolone received FDA orphan drug designation in 2023. Umecrine Cognition is actively advancing its pipeline. In 2026, the company reported the last patient out in a Phase 1b/2a study evaluating golexanolone in primary biliary cholangitis, enrolled the last patient in that ongoing study, and received Notices of Allowance in the US for patents protecting second-generation GAMSA compounds. The company publishes annual reports and press releases through its website.

Umecrine Cognition AB is a Swedish pharmaceutical company based in Solna, Sweden. The company was established to develop a novel class of drugs known as GABAA receptor-modulating steroid antagonists (GAMSAs), which target neurological disorders caused by neuroinflammation. Its scientific focus is on the GAMSA mechanism, and its lead product candidate is golexanolone, a small molecule designed to counteract the overactivation of GABA-A receptors by the neurosteroid allopregnanolone. The company's most advanced clinical program for golexanolone has been in hepatic encephalopathy, a liver disease complication. Results from an internationally acclaimed Phase 2 study indicated that golexanolone improves brain signaling, cognition, and alertness in patients with hepatic encephalopathy. This provided a foundation for further development in patient groups whose symptoms arise from chronic liver diseases. By 2023, golexanolone had received orphan drug designation from the US Food and Drug Administration (FDA). The company has since expanded its clinical focus to primary biliary cholangitis (PBC), a rare chronic liver disease. In 2026, Umecrine Cognition reported significant progress in a Phase 1b/2a study evaluating golexanolone in PBC patients with central fatigue. On August 3, 2026, the company announced the enrollment of the last patient in the ongoing study. On September 15, 2026, it reported that the last patient had completed the final follow-up visit. Additionally, on September 7, 2026, the company received two Notices of Allowance from the United States Patent and Trademark Office for patents protecting second-generation GAMSA compounds, indicating ongoing efforts to strengthen its intellectual property portfolio. Umecrine Cognition continues to evaluate other indications for its GAMSA platform, including neurodegenerative diseases such as Parkinson's disease. The company operates as a clinical-stage entity, with its activities centered on drug development, clinical trials, and regulatory interactions. It publishes annual reports and press releases through its website, maintaining transparency with stakeholders.

• Golexanolone received FDA orphan drug designation.

• Umecrine Cognition enrolls last patient in its ongoing Phase 1b/2a study of golexanolone.

• Umecrine Cognition receives two Notices of Allowance from the United States Patent and Trademark Office for patents protecting second-generation GAMSA compounds.

• Umecrine Cognition reports last patient out in Phase 1b/2a study evaluating golexanolone in primary biliary cholangitis.

Clinical-stage pharmaceutical company developing a novel class of drugs for neurological disorders caused by neuroinflammation, with a focus on cognitive impairment and fatigue associated with chronic liver diseases and neurodegenerative diseases.

• golexanolone

  A novel small molecule GABAA receptor-modulating steroid antagonist in development for the treatment of neurological disorders caused by overactivation of GABA-A receptors by the neurosteroid allopregnanolone. It is in Phase 2 clinical development for primary biliary cholangitis with central fatigue and has been studied in hepatic encephalopathy.

1. 1Umecrine Cognition official website homepageumecrinecognition.com
2. 2The Company in brief – Umecrine Cognitionumecrinecognition.com
3. 3Market – Umecrine Cognitionumecrinecognition.com
4. 4Wikidata: Umecrine Cognition AB (Sweden)wikidata.org