In short
Deramciclane is a putative anxiolytic drug that acts on serotonin receptors in the brain. It is an investigational substance that has not been authorised as a medicine in the records provided. One clinical trial record (NCT07284472) was found in the registry data, but it investigates EXV-801 and EXV-802, not deramciclane itself. The supplementary source describes deramciclane as a serotonin 5-HT2C receptor inverse agonist studied in preclinical research.
Key points
- Deramciclane is a putative anxiolytic drug that acts as a serotonin 5-HT2C receptor inverse agonist.
- The substance was studied in preclinical research and is not authorised as a medicine in the available records.
- The one registered trial found (NCT07284472) is a Phase 4 study of EXV-801 and EXV-802, not deramciclane.
- The trial measures agitation symptoms in people with Alzheimer's disease dementia using the Cohen-Mansfield Agitation Inventory.
- The trial plans to enrol 324 participants and is currently authorised.
What is deramciclane?
Deramciclane (also known by the development code EGIS-3886) is a putative anxiolytic drug, meaning it was investigated as a potential treatment for anxiety. It is a chemically synthesised small-molecule substance that binds with high affinity to serotonin 5-HT2A and 5-HT2C receptors in the brain. Deramciclane is an investigational substance; no marketing authorisation is recorded in the available data.
How does deramciclane work?
Deramciclane acts as a serotonin 5-HT2C receptor inverse agonist. This means it binds to the 5-HT2C receptor and reduces its activity below the normal resting level, rather than simply blocking the receptor. In laboratory studies, deramciclane decreased basal phosphoinositide hydrolysis by up to 33%, which reflects reduced signalling through the 5-HT2C receptor pathway. The substance also binds to 5-HT2A receptors, with receptor occupancy of up to 78% reported in preclinical studies. Chronic treatment with deramciclane did not lead to down-regulation of 5-HT2C receptors, meaning the receptors did not decrease in number after repeated dosing.
Which conditions is deramciclane studied for?
- Anxiety — deramciclane was investigated as a putative anxiolytic agent in preclinical research.
The registered clinical trial found in the data does not study deramciclane. It investigates two other substances, EXV-801 and EXV-802, for agitation in Alzheimer's disease dementia.
How is deramciclane given?
The available supplementary source does not describe a pharmaceutical form or route of administration for deramciclane in humans. The preclinical studies used doses of 0.5 mg/kg and 10 mg/kg in animal models, but no formulation details are provided. The registered trial involves oral administration of EXV-801 and EXV-802, which are separate substances.
What do the clinical trials show?
The registry data contains one clinical trial, but it does not investigate deramciclane. The trial with identifier NCT07284472 is a Phase 4 study evaluating EXV-801 and EXV-802 in people with agitation in Alzheimer's disease dementia. It is an interventional study that plans to enrol 324 participants and is currently authorised. The primary outcome measures the difference between active treatment and placebo using the Cohen-Mansfield Agitation Inventory total score, assessed from baseline to week 6. No clinical trials of deramciclane itself were found in the registry data provided.
What side effects are known?
The supplementary source does not report side effects of deramciclane in humans. The preclinical article focuses on receptor binding and occupancy and does not describe adverse events.