Ekaterina Malievskaia
Co-Founder and Chief Medical Officer, COMPASS Pathways
Co-founder and driving medical force behind COMPASS Pathways, the company running the largest psilocybin Phase 3 clinical trials for treatment-resistant depression in history.
Biography
Ekaterina Malievskaia is the co-founder and Chief Medical Officer of COMPASS Pathways, the UK-based biotechnology company she founded alongside her husband George Goldsmith after their son's severe treatment-resistant depression led them to investigate psilocybin as a therapeutic option. What began as a personal mission became the world's largest and best-funded psilocybin clinical research program.
Malievskaia's background in internal medicine and her role as a physician informed COMPASS's approach to psilocybin as a regulated pharmaceutical intervention. Under her medical leadership, COMPASS ran the largest Phase 2b trial of psilocybin for treatment-resistant depression (TRD) in history — COMP360 — with 233 participants across ten countries, published in the New England Journal of Medicine in 2022. The 25mg dose arm showed statistically significant reduction in depression scores versus lower doses and placebo. COMPASS has since advanced to Phase 3 trials.
Malievskaia has navigated the dual challenges of defending COMPASS's for-profit model against critics in the psychedelic community who argue pharmaceutical IP structures will limit access, while simultaneously advocating to regulatory bodies that psilocybin therapy can and should be made available as a standard treatment. She has testified before European regulatory agencies and spoken at major medical conferences about the path to regulatory approval for psilocybin therapy.
Organizations
Why They Matter to the LearnShrooms Community
Malievskaia leads the program most likely to produce the first regulatory approval of psilocybin as a prescription therapy in the US or Europe. The outcome of COMPASS's Phase 3 trials will define the regulatory baseline for the entire psilocybin medicine category.
