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CYB003

Phase 3Small molecule

CCybin IRL Limited

CYB003 is one of 70 small molecule programs targeting Anxiety. It is currently in Phase 3.

3

Indications

5

Total Trials

4

Active Trials

69

Competitors

Pipeline

Status by Indication[3][1]

Indication

AnxietyActive, not recruiting

Major Depressive DisorderRecruiting

Major Depressive Disorder (MDD)Recruiting

AnxietyPhase 2

Active, not recruiting

Major Depressive DisorderPhase 3

Recruiting

Major Depressive Disorder (MDD)Phase 3

Recruiting

Competition

Competitive Landscape

386 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Quetiapine XR

Lithobid

SSolvay Pharmaceuticals

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Rapastinel

AXS-05

AAxsome Therapeutics, Inc.

SR58611A

Aticaprant

Johnson & Johnson

CYB003

CCybin IRL Limited

MM120

DDefinium Therapeutics US, Inc.

Amibegron (SR58611A)

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

Major Depressive Disorder

NCT06564818

Q2 2027

Phase 3Recruiting

Major Depressive Disorder (MDD)

NCT06793397

Q4 2027

Phase 2Not yet recruiting

Anxiety

NCT06820723

Clinical

Trials by Indication[1]

Major Depressive Disorder3 trials

A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder

Completed·CCybin IRL Limited·Phase 1/2·NCT05385783·57 enrolled

A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)

Enrolling by invitation·CCybin IRL Limited·Phase 3·NCT06605105·468 enrolled

A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans With Major Depressive Disorder

Recruiting·CCybin IRL Limited·Phase 3·NCT06564818·220 enrolled

Anxiety1 trial

A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety

Not yet recruiting·OOhio State University·Phase 2·NCT06820723·40 enrolled

Major Depressive Disorder (MDD)1 trial

An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder

Recruiting·CCybin IRL Limited·Phase 3·NCT06793397·330 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for CYB003. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — CYB003 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for CYB003. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Cybin IRL Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCybin IRL Limited

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