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

Phase 3 Enrolling by invitation 468 enrolled Cybin IRL Limited Worldwide Clinical Trials · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2025-07-18
Primary completion: 2028-03-15
Completion: 2028-03-15

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CYB003	Unknown	16 mg	—

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

Summary

Timeline

Drugs

Indications