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:
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
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