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A Phase 2 Study randomized, double-blind, two-part (Part A and Part B) Proof-of-Concept clinical study evaluating CYC-126 in Treatment Resistant Depression who are candidates for monitored anesthesia

Trial Profile

A Phase 2 Study randomized, double-blind, two-part (Part A and Part B) Proof-of-Concept clinical study evaluating CYC-126 in Treatment Resistant Depression who are candidates for monitored anesthesia

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2026

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At a glance

  • Drugs Dexmedetomidine/propofol (Primary)
  • Indications Treatment-resistant depressive disorder
  • Focus Proof of concept; Therapeutic Use

Most Recent Events

  • 03 Mar 2026 New trial record
  • 17 Feb 2026 According to Cyclerion Therapeutics media release, company received Positive Pre-Investigational New Drug (IND) Written Feedback from the U.S. Food and Drug Administration on CYC-126 Phase 2 POC study in TRD and its path to potential regulatory approval.
  • 17 Feb 2026 According to Cyclerion Therapeutics media release, Company remains on track to initiate the Phase 2 study in the second half of 2026, with the first patient to be enrolled in Australia and U.S. enrollment commencing in the first half of 2027.

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