FSD BioSciences is focused on bringing innovative prescription products to market formulated from its proprietary micro-PEA development platform through independent or concomitant use of micro-PEA to address multiple disease conditions.

Research Areas

FSD BioSciences holds the exclusive worldwide licensing rights (except Italy and Spain) to ultra- micronized-PEA for all conditions in all regulatory categories. It has a strong IP portfolio covering ultra-micronized composition of matter and use (2029-34 U.S. expiration).

Lead candidate is FSD201 – 600mg ultra-micronized-PEA:

  • Successfully completed Phase 1 first-in-human safety and tolerability trial with no serious adverse effects discovered.

Target indications for Phase 2a trial:

  • COVID-19

Potential target indication areas for Phase 2 trials:

  • Osteoarthritis of the knee
  • Women’s health, including endometriosis
  • Chronic pain, including opioid replacement and/or sparing

Ultra-micronized PEA

PEA (palmitoylethanolamide) is a fatty acid amide that has been studied for its anti-inflammatory and analgesic actions.

  • Ultra-micronized-PEA enhances the efficacy and potency of PEA’s anti-inflammatory and analgesic therapeutic properties
  • Formulations utilize micro-PEA “entourage” effect on certain drugs that impact the endocannabinoid system
  • Offers greater absorption and bioavailability, preclinical and clinical efficacy, and a favorable safety profile
  • Delivers clinically meaningful anti-inflammatory properties
  • A robust clinical safety dataset exists with considerable literature in the European Union on its efficacy