Back to Stakeholders
Lead program: Phase II
Categories

1 domain / 2 areas / 1 specialization

Mydecine InnovationsNEO: MYCO

Data updated

2 Drug Candidates

Canadian biotech using AI-assisted drug discovery at the University of Alberta to develop novel psilocybin and MDMA analogues for mental health and addiction treatment. Pipeline compounds MYCO-003 through MYCO-007 represent a library of psychedelic-inspired molecules at preclinical stage.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
2

All tracked candidates active

Active programmes
3

All tracked programmes active

Lead stage
Phase II

Multiple active stages

Forecast coverage
3 of 3

3 active programmes with forecast fields

Latest sourced update

Psychedelic Alpha - Psychedelic Drug Development Tracker

Jun 26, 2026 - industry-media - Psychedelic Alpha - MYCO-001

Next known catalyst

Phase II topline

Timing not specified - MYCO-001 / MYCO-001 Phase 2b Programme (Smoking Cessation) - Confidence: 55%

6 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase II1 Preclinical

Development Programmes

2

MYCO-001

Psilocybin
Phase II

Smoking cessation / PTSD

Programme Tracker

Substance Use Disorders (SUD)

Primary: US (FDA)
Phase IIActive

Forecast

Phase II topline

Phase 2b multi-site placebo-controlled trial; PI: Dr. Matthew Johnson (Johns Hopkins); sites: Hopkins, NYU, UAB; IND filed with FDA

Milestones

Phase II started

Completed

Actual: Sep 1, 2022

Phase 2b seamless smoking cessation trial initiated with Johns Hopkins partnership; IRB conditional approval received

Why it matters: MYCO-001 is a 99.9% pure natural-source psilocybin developed in partnership with Johns Hopkins' Dr. Matthew Johnson — the researcher behind the landmark 2022 JAMA Psychiatry smoking cessation study (80% abstinence at 12 months). The Phase 2b replicates this design at multiple sites.

Watch next: Phase 2b 3-month and 6-month abstinence primary endpoint results

Recorded Events

Sep 1, 2022: Phase II started

PTSD

Primary: UK (MHRA)
Phase IIActive

Forecast

Phase II topline

Phase 2a in veteran PTSD; partnership with Combat Stress (UK) and King's College London; PI: Dr. Rakesh Jetly

Milestones

Phase II started

Completed

Actual: Jan 24, 2022

Partnership with Combat Stress and King's College London announced for veteran PTSD trial

Why it matters: Dr. Rakesh Jetly is the leading clinical researcher for psilocybin PTSD trials in veterans. Combat Stress is the UK's leading veteran mental health charity. This partnership brings credibility and access to a high-burden, treatment-resistant PTSD population.

Watch next: Phase 2a results in veteran PTSD cohort

Recorded Events

Jan 24, 2022: Phase II started

Evidence Links

Mydecine Announces MYCO-001 Seamless Phase 2/3 Smoking Cessation Trial

Press release - GlobeNewswire / Mydecine - Sep 7, 2021 - Verified

Mydecine announced a planned placebo-controlled Phase 2/3 MYCO-001 smoking cessation study with Johns Hopkins; no current registry match was found in June 2026 checks.

Mydecine Provides Company Update on Clinical Trials and Drug Development

Press release - GlobeNewswire / Mydecine - Dec 9, 2021 - Verified

Company update describes MYCO-001 smoking cessation and PTSD Phase 2 plans; no recent 2025-2026 development update was found in this pass.

Psychedelic Alpha - Psychedelic Drug Development Tracker

industry-media - Psychedelic Alpha - Jun 26, 2026 - Verified

Industry tracker continues to list MYCO-001 in clinical-stage psychedelic drug development, but current primary-source progress remains thin.

MYCO-004

Preclinical

Substance use disorder / smoking cessation

Programme Tracker

Substance Use Disorders (SUD)

Primary: US (FDA)
Pre-clinicalActive

MYCO-004 remains supported mainly by 2021 Mydecine disclosures as a patch-delivered tryptamine for SUD/smoking cessation. Mydecine changed its public company name to Noveris Health Sciences in February 2026; no recent MYCO-004 clinical-start confirmation was found.

Milestones

Pre-clinical completed

In progress

Why it matters: MYCO-004 is a transdermal tryptamine — distinct from MYCO-001's oral psilocybin. Patch delivery could enable controlled, slow-release dosing (potentially sub-perceptual) without the 4–6 hour oral psychedelic session, expanding access to patients unwilling or unable to undergo full psychedelic sessions.

Watch next: Preclinical PK/PD data and indication selection for IND

Evidence Links

Mydecine Announces Four Lead Novel Drug Candidates

Press release - GlobeNewswire / Mydecine - Apr 7, 2021 - Verified

Announcement identifies MYCO-004 as a patch-delivered tryptamine compound with short duration and precision dosing.

Mydecine Selects Substance Use Disorder and Smoking Cessation for MYCO-004

Press release - FirstWord Pharma / Mydecine - Jun 1, 2021 - Verified

Announcement supports substance-use disorder and smoking-cessation positioning for MYCO-004.

CSE Bulletin - Mydecine Name and Symbol Change

exchange-notice - Canadian Securities Exchange / Newsfile - Feb 2, 2026 - Verified

CSE bulletin records Mydecine Innovations Group name change to Noveris Health Sciences, useful for current company tracking.

Similar Developers

Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.

View landscape
Filament Health
Phase II1 active candidate3 trials
2 shared indicationsPhase II peer2 shared regulatorssimilar active pipeline size
Reconnect Labs
Phase II3 active candidates2 trials
2 shared indicationsPhase II peersame regulator: US FDAsimilar active pipeline size
Otsuka Pharmaceutical
Phase III2 active candidates
shared compound: Psilocybinsame indication: PTSD2 shared regulatorssimilar active pipeline size
Apex Labs
Phase II2 active candidates1 trial
shared compound: Psilocybinsame indication: PTSDPhase II peersimilar active pipeline size

Quick Facts

Type
Public Biotech
Ticker
NEO: MYCO
Lead Stage
Phase II
Website
Visit