In short
Deupsilocin besilate, also known by its development code CYB003, is an investigational substance being studied for major depressive disorder (MDD). Two Phase 3 clinical trials are currently authorised, together involving 852 participants. One trial compares two doses of CYB003 against placebo in 330 adults, while the other follows 522 participants to assess how long treatment effects last.
Key points
- Deupsilocin besilate (CYB003) is an investigational substance for major depressive disorder.
- Two Phase 3 trials are authorised, with 852 participants in total.
- One trial tests 8 mg and 16 mg oral doses against placebo in 330 adults.
- The primary measure is change in the MADRS depression score from baseline to Day 42.
- A second trial follows 522 participants to measure time to relapse after initial treatment.
- Both trials are authorised and interventional.
What is deupsilocin besilate?
Deupsilocin besilate is an investigational substance being developed under the code name CYB003. It is not currently authorised as a medicine. The substance is being studied in interventional clinical trials for major depressive disorder (MDD), a condition characterised by persistent low mood and loss of interest or pleasure in daily activities.
How does deupsilocin besilate work?
The clinical trial records provided do not describe the mechanism of action of deupsilocin besilate. No supplementary sources were included in the data for this page, so the molecular target and pharmacological action of the substance are not stated here.
Which conditions is deupsilocin besilate studied for?
- Major depressive disorder (MDD) — both authorised Phase 3 trials investigate CYB003 in adults with this condition.
How is deupsilocin besilate given?
In the clinical trials, deupsilocin besilate (CYB003) is given orally. One trial uses a 16 mg oral dose in its long-term extension phase. Another trial compares two oral doses, 8 mg and 16 mg, against placebo. The trial records do not specify the pharmaceutical form beyond oral administration.
What do the clinical trials show?
Two Phase 3 trials of CYB003 in major depressive disorder are authorised. The first, NCT06793397, is a Phase 3 trial assessing the efficacy of two administrations of CYB003 compared to placebo in treating symptoms of MDD in adult participants. It plans to enrol 330 participants and measures change from baseline (Day -4 to -1) to Day 42 in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score, a standard scale used to assess the severity of depressive symptoms.
The second trial, NCT06605105, is a Phase 3 long-term extension trial called EXTEND. It assesses the safety and efficacy of CYB003 in participants who have had a stable response in either the APPROACH or EMBRACE trial. It plans to enrol 522 participants and measures the time to first relapse from the baseline of the EXTEND trial.
Who can take part in these trials?
The trial records indicate that both studies involve adult participants with major depressive disorder. The long-term extension trial (EXTEND) is specifically for participants who have had a stable response in either the APPROACH or EMBRACE trial. Further eligibility criteria are not detailed in the registry records provided.