drug development

Leaders in botanical psychedelic drug development.

Psychedelic mushrooms in lab
In-house Development Program

We are demonstrating the safety and efficacy of botanical psychedelic drug candidates for the first time in human clinical trials:

Stimulant Use Disorder

  • In the latest (2021) national survey, 11 million Americans reported stimulant misuse and 4.5 million reported a stimulant use disorder (StUD)1

  • From 2012 through 2019, the fatal overdose rate increased on average by 29% per year to 5.0 deaths per 100,000 standard population2
  • Side effects of StUD include violent outbursts and aggressive behaviour
  • Three subcategories share similar or identical mechanisms of action:
  • Methamphetamine use disorder, cocaine use disorder and prescription stimulant use disorder
  • There are no approved treatments for StUD
  • Filament estimates addressable StUD patient population of 835,000 with peak annual revenues of US$1.2 billion3
Sponsor
Indication
Phase I
Phase II
Phase III
Start
n
Product
Purpose
Stimulant Use Disorder
Filament Health
H1 2025*
90
PEX010 (25mg)
Planned 90 person controlled study – psilocybin for stimulant use disorder; H1 2025*
Approval Pending
Trial Approved
*Anticipated start date

Opioid Use Disorder

  • In the latest (2021) national survey, 9.2 million Americans reported opioid misuse of which 5.6 million reported an opioid use disorder (OUD)1

  • Overdose deaths nearly doubled from 7.4 to 15.5 deaths per 100,000 standard population from 2012 to 20192
  • The global opioid use disorder pharmaceutical market is projected to grow from $3.35 billion in 2023 to $6.14 billion by 2030, at a CAGR of 9.1%3
  • Existing therapies are poor:
  • Substitution therapy replaces misused opioid with prescription opioid agonist (58% retention at 6 months4)
  • Antagonist therapy requires complete detox and abstinence and monthly injections, and can lead to more deadly relapses (50% 6-month retention5)
  • Filament forecasts addressable OUD patient population of 295,000 with peak annual revenues of ~$387 million6
Sponsor
Indication
Phase I
Phase II
Phase III
Start
n
Product
Purpose
Opioid Use Disorder
Filament Health
H1 2025*
10
PEX010 (25mg)
Pilot open label study - psilocybin for opioid use disorder. Planned 10 person multicentre study, H1 2025*
Processing Ayahuasca in the Filament lab
Academic AND PhilanthropiC Partnerships

Enabling a Thriving Research Ecosystem

This is a way for Filament Health to support the psychedelic research community. Collaborative partnerships with leading academic institutions also generate pivotal efficacy and safety data and provide data preview and insights into novel clinical applications.

Sponsor
Phase I
Phase II
Phase III
Drug
Dosage
Indication
Boredom Lab
PEX010
1mg
Depression
CHU Brugmann
PEX010
25mg
Alcohol Use Disorder
Copenhagen University Hospital
PEX010
25mg
Alcohol Use Disorder
Centre for Addiction and Mental Health (CAMH)
PEX010
25mg
Treatment-Resistant Depression
Centre for Addiction and Mental Health (CAMH)
PEX010
25mg
Dementia & Mild Cognitive Impairment
University Of Calgary
PEX010
25mg
Alcohol Use Disorder
Trial Approved
Partnership network development program

On a limited basis, we entertain manufacturing partnerships, joint ventures, and other collaborations.

Reach out to speak to us about an idea or collaboration.We believe that our botanical drugs could be effective in many therapeutic areas and that research on multiple indications is necessary. Our patented technology provides an attractive platform whereby third-party drug developers can leverage our IP and regulatory expertise by using Filament’s drug candidates in their clinical trials.

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