Psychedelic Therapeutics BD Intelligence Brief | 2026-09-20

Key Updates

• Clinical Trials: 7 changes, including 4 new trials and 3 status updates.
• Regulatory: No relevant Health Canada updates.
• Funding: No NIH grant announcements.

Clinical Trial Highlights

1. New Trials
- NCT07820033: Psilocybin-assisted PEARL Therapy for Advanced Cancer (Phase 2, University Health Network).
- NCT07818564: Psilocybin on Belief Updating & Insight Formation (Phase 1, Brown University).
- NCT07818720: MLS101 Study in PMDD (Phase 1, MycoMedica Life Sciences).
- NCT06943573: Psilocybin for Treatment-Resistant Depression in Bipolar II (Phase 2, Lakshmi N Yatham).

2. Status Changes
- NCT07180108 (PRoMiSS): Status upgraded to RECRUITING (Johns Hopkins).
- NCT06943573: Status upgraded to RECRUITING (Lakshmi N Yatham).
- NCT07607938: Status upgraded to RECRUITING (NYU Langone).
- NCT05000866 (MDMA): Completion date extended to 2027-01-31 (Hunter College).

Market & Regulatory Trends

• Health Canada: No new guidance or policy updates.
• Funding: No NIH grants announced for psychedelic research.

Strategic Takeaways

• Pipeline Momentum: 4 new trials in Phase 1/2 suggest growing interest in psilocybin for oncology, mood disorders, and PMDD.
• Trial Recruitment: Increased recruitment activity (e.g., PRoMiSS, Bipolar II depression) may signal readiness for larger-scale studies.
• MDMA Extension: Extended timeline for the MDMA trial could reflect logistical challenges or expanded study scope.

Next Steps: Monitor recruitment progress for Phase 2 trials and track MDMA trial updates. Stay alert for potential funding announcements or regulatory changes.