Filament HealthNEO: FH | OTCQB: FLHLF | FSE: 7QS
Clinical-stage natural psychedelic drug development company with publicly announced Nagoya Protocol-compliant iboga import activity from Gabon for R&D and potential therapeutic development.
Manufacturing Snapshot
Psychedelic-Focused ManufacturerScope & Capabilities
Supply Use Cases
GxP / Compliance
Facilities & Access
GMP-compliant facility with proprietary extraction, purification, and stabilization workflows.
Manufacturing DetailsSupported Substances
Natural psychedelic drug candidates, including psilocybin and additional botanical compounds.
Regulatory Authorizations
1 authorizationManufacturing Sources
ABS & Biocultural Rights Governance Snapshot
ABS Compliance & Monitoring BodiesOrganization Type
Multi-Role
Jurisdiction
Regional
Coverage
2 countries
Last Verified
Apr 15, 2026
Function Areas
Compliance Mechanisms
Governance Notes
Filament reports completion of a Nagoya Protocol-compliant import of iboga root from Gabon authorized by the Gabonese government, indicating operational ABS linkage for iboga supply.
Verification
Verified
Psychedelic Engagement
Explicit Psychedelic Focus
Framework Status
Active
Framework / Program
Nagoya Protocol-compliant iboga shipment framework
Development Programmes
1PEX010 (Botanical Psilocybin)
Botanical (naturally-derived) psilocybin drug candidate. Standardised extraction from Psilocybe mushrooms — retains full-spectrum alkaloid profile. GMP-manufactured at 35,000 sq ft Burnaby, BC facility. Health Canada Level 8 Controlled Substances Dealer's Licence. 76 patents across 15 families covering extraction, purification, standardisation, stabilisation, and delivery. 51-53 active clinical trials across 14 mental health indications at 70+ sites globally including Johns Hopkins, Dana-Farber, UCSF, UPenn, UBC, UCL, Psychiatric Centre Copenhagen.
Programme Tracker
Alcohol Use Disorder (AUD)
Phase 2 POSITIVE DATA announced March 2025. Study at Psychiatric Centre Copenhagen (completed) and University of Washington. Additional Phase 2 for PTSD+AUD in veterans/first responders authorized by FDA July 2025 at University of Washington, funded by State of Washington.
Milestones
data-readout
CompletedActual: Mar 1, 2025
Positive Phase 2 data announced for PEX010 in patients with alcohol use disorder. Study conducted at Psychiatric Centre Copenhagen.
Why it matters: First positive Phase 2 efficacy signal for botanical psilocybin in AUD. Validates the botanical (full-spectrum) approach vs synthetic psilocybin used by competitors. AUD is a major indication with high unmet need — current treatments (naltrexone, acamprosate) have modest efficacy.
regulatory-milestone
CompletedActual: Jul 7, 2025
FDA authorizes Phase 2 clinical trial studying PEX010 for PTSD + AUD in military veterans and first responders. Study at University of Washington, funded by State of Washington.
Why it matters: Combined PTSD+AUD indication targets the dual-diagnosis population where standard treatments fail most. Government-funded study validates medical and public health interest. Veterans/first responders population has high PTSD+AUD comorbidity.
Recorded Events
Jul 7, 2025: regulatory-milestone
Mar 1, 2025: data-readout
Opioid Use Disorder (OUD)
FDA authorized Phase 2 clinical trial at University of Pennsylvania (April 2025). Funded by Wellcome Leap. Studying psilocybin-assisted therapy for opioid use disorder.
Milestones
regulatory-milestone
CompletedActual: Apr 1, 2025
FDA authorizes Phase 2 clinical trial studying PEX010 in opioid use disorder at University of Pennsylvania. Wellcome Leap funded.
Why it matters: OUD is the deadliest substance use disorder (>80,000 US opioid deaths/year). Wellcome Leap funding from one of the world's largest health research foundations signals institutional credibility. UPenn is a tier-1 clinical research site.
Recorded Events
Apr 1, 2025: regulatory-milestone
Substance Use Disorders (SUD)
Phase 2 authorized at University of British Columbia for methamphetamine use disorder (MAUD). Health Canada regulatory pathway.
Milestones
regulatory-milestone
CompletedActual: Sep 1, 2024
Authorization of Phase 2 clinical trial for PEX010 in methamphetamine use disorder at University of British Columbia.
Why it matters: MAUD has ZERO FDA/HC-approved treatments — entirely unmet medical need. Methamphetamine use is surging globally. If psilocybin shows efficacy here, it could be first-in-class.
Recorded Events
Sep 1, 2024: regulatory-milestone
Major Depressive Disorder (MDD)
Two Phase 2 trials in partnership with University College London, MHRA approved (July 2025). Investigating effects on brain function, perception, and psychological well-being.
Milestones
partnership
CompletedActual: Jul 24, 2025
Two Phase 2 research trials announced in partnership with University College London. MHRA approved. Studying PEX010 effects on brain function, perception, and psychological well-being.
Why it matters: UCL is a world-leading psychedelic research centre (home to Carhart-Harris lab alumni). MHRA approval expands PEX010's regulatory footprint beyond North America. Brain function data could provide mechanistic insights supporting all PEX010 indications.
Recorded Events
Jul 24, 2025: partnership
Evidence Links
Press release - Filament Health - Jul 31, 2025 - Verified
Press release - Filament Health - Aug 1, 2024 - Verified
Press release - NASDAQ / Red Light Holland - Mar 10, 2026 - Verified
company-website - Filament Health - Verified
Quick Facts
- Type
- Public Biotech
- Ticker
- NEO: FH | OTCQB: FLHLF | FSE: 7QS
- Lead Stage
- Phase II
- Website
- Visit