In short
(2R)-2-CYCLOPROPYL-2-{(1R,3S,5S)-3-[(3S,4R)-1-(5-FLUOROPYRIMIDIN-2-YL)-3-METHOXYPIPERIDIN-4-YL]-8-AZABICYCLO[3.2.1]OCTAN-8-YL}ACETAMIDE, also known by its development code E2086, is an investigational substance studied for narcolepsy. The clinical trial record shows one completed Phase 2 study in 64 adults with narcolepsy, testing whether E2086 reduces excessive daytime sleepiness compared with placebo. The registry data do not state a marketing authorisation for this substance.
Key points
- E2086 is an investigational substance studied for narcolepsy.
- The only registered trial is a Phase 2 study in 64 adults.
- The trial is completed and compared E2086 with placebo.
- The main measure was mean sleep latency on maintenance of wakefulness tests.
- The study included people with narcolepsy type 1 and type 2.
What is E2086?
E2086 is the development code for (2R)-2-CYCLOPROPYL-2-{(1R,3S,5S)-3-[(3S,4R)-1-(5-FLUOROPYRIMIDIN-2-YL)-3-METHOXYPIPERIDIN-4-YL]-8-AZABICYCLO[3.2.1]OCTAN-8-YL}ACETAMIDE, an investigational substance studied in adults with narcolepsy. The registry record for the trial lists the substance under the name E2086 and gives no trade name or marketing authorisation, which means it is still being researched rather than available as an authorised medicine. The trial record does not state the chemical class or origin of the substance.
How does E2086 work?
The clinical trial record does not describe the mechanism of action of E2086. The study measured whether the substance reduced excessive daytime sleepiness in people with narcolepsy, but the registry data do not explain how the substance acts in the body.
Which conditions is E2086 studied for?
- Narcolepsy — a long-term sleep disorder that causes excessive daytime sleepiness and sudden sleep attacks. The trial included people with narcolepsy type 1 and narcolepsy type 2.
How is E2086 given?
In the registered trial, E2086 was given by mouth as tablets. The trial also used placebo tablets that matched the E2086 tablets in shape and appearance. The registry record does not state the strength of the E2086 tablets, because the dose is recorded as 0 mg, meaning the dose was not reported in the register.
What do the clinical trials show?
One Phase 2 trial of E2086 in narcolepsy is registered. The trial enrolled 64 adults and is completed. The primary purpose was to evaluate the optimal doses of E2086 compared with placebo for reduction of excessive daytime sleepiness. The main measure was the change from baseline to week 4 in mean sleep latency, assessed across four maintenance of wakefulness tests, in people with narcolepsy type 1 and narcolepsy type 2. Mean sleep latency is the average time a person can stay awake in a quiet setting, and a longer time usually means less daytime sleepiness.
Who can take part in these trials?
The registered trial enrolled adults with narcolepsy type 1 or narcolepsy type 2. The trial record does not list further inclusion or exclusion criteria such as age limits beyond adults, other medical conditions, or previous treatments.
What are the trials measuring?
The primary outcome was the change from baseline to week 4 in mean sleep latency for E2086 compared with placebo across four maintenance of wakefulness tests. The registry record does not list secondary outcomes or results.
What side effects are known?
The clinical trial record does not report side effects of E2086.