Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)

Cybin IRL Limited

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Brief summary

This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym
EXTEND
status
ENROLLING_BY_INVITATION
phase
PHASE3
study type
INTERVENTIONAL
enrollment
468
sponsor
Cybin IRL Limited
conditions
Major Depressive Disorder
interventions
DRUG: CYB003
start date
2025-07-18
start date type
ACTUAL
primary completion date
2028-06-06
has results
false
data source
ClinicalTrials.gov
data processed
2026-10-29T09:00:05
modifications
selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Record

Archive ID
nct:NCT06605105
Published
Sep 20, 2024
Updated
Sep 25, 2026
Venue
ClinicalTrials.gov
ClinicalTrials.gov
NCT06605105
Categories
Major Depressive Disorder
License
ClinicalTrials.gov terms (attribution, processing date, modifications noted)
Provenance
clinicaltrials

Topics