MycoMedica registers the first psilocybin trial for PMDD, testing repeated low doses without a mandated psychotherapy component

MycoMedica Life Sciences has registered NCT07818720, the first psilocybin trial for premenstrual dysphoric disorder, but the Phase 1b study is designed only to assess safety and tolerability, not symptom relief. Thirty-two premenopausal women will be randomized to placebo or repeated 2, 4, or 8 milligram MLS101 doses, administered in clinic every three days across a 16-day luteal-phase treatment window. Participants will receive at least eight hours of monitoring after each dose, with adverse events through week 11 as the primary endpoint and pharmacokinetic, cognitive, psychiatric, sleep, and cardiac measures as secondary outcomes. Unlike several leading psychedelic programs, the protocol does not include preparation, psychotherapy, or integration sessions. The lower-dose, lower-burden model may reduce staffing and access barriers, but its central premise remains unproven: clinically meaningful efficacy at these doses without structured psychological support has not been established. The trial was not yet recruiting and had an estimated December 2026 start date.