CYB003

Phase 3Small molecule

CCybin IRL Limited

CYB003 is one of 54 small molecule programs targeting Major Depressive Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Major Depressive DisorderEnrolling by invitation

Major Depressive Disorder (MDD)Recruiting

Major Depressive DisorderPhase 3

Enrolling by invitation

Major Depressive Disorder (MDD)Phase 3

Recruiting

Competition

Competitive Landscape

115 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Cymbalta

Jazz Pharmaceuticals

Approved

26 2

Ozempic

Novo Nordisk

Approved

2 3

Rozerem

Takeda

Approved

1 4

Effexor

WWyeth-Lederle Vaccines

Approved

8 5

Ulotaront

IIntra-Cellular Therapies, Inc.

Approved

6 6

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 7

Ketalar

Boehringer Ingelheim

Phase 3

5 8

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 9

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 10

Psilocybin

COMPASS Pathways

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Phase 3Recruiting

Major Depressive Disorder (MDD)

NCT06793397

Q4 2028

Phase 2Recruiting

Depression

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

Completed·CCybin IRL Limited·Phase 3·NCT06564818·223 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

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

Depression1 trial

A Randomized, Double-Blind, Placebo-Controlled Mechanistic Study to Assess a Single Oral Dose of CYB003 in Participants With Major Depressive Disorder (MDD) and Moderate to Severe Anxiety

Recruiting·OOhio State University·Phase 2·NCT06820723·40 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

CYB003

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2028

Trials by Indication[1]

Major Depressive Disorder3 trials

Major Depressive Disorder (MDD)1 trial

Depression1 trial

References

Drug Info

Quick Facts

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