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Life sciences · Phase 1 Trial
ClinicalTrials.gov · September 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT07818720). This is a study registration, not published results. Lead sponsor: MycoMedica Life Sciences PBC. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 32 participants (ESTIMATED). Conditions: Premenstrual Dysphoric Disorder ( PMDD), PMDD. Interventions: DRUG: MLS101 psilocybin; DRUG: Placebo capsules. Primary outcome measures: Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 , From baseline through the final telehealth visit at week 11. Brief summary: The goal of this clinical trial is to learn if MLS101 (psilocybin) is a possible treatment for women with Premenstrual Dysphoric Disorder (PMDD). The main question it aims to answer is: • Test the safety and tolerability of the study drug, MLS101 in premenopausal women (ages 18-50 inclusive) with PMDD.