MLS101 Study in PMDD
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. (The sponsor's summary, shortened.)
Eligibility and contacts on ClinicalTrials.govThe registry record
- Status
- Not yet recruiting
- Phase
- Phase 1
- Conditions
- Premenstrual Dysphoric Disorder ( PMDD); PMDD
- Intervention
- MLS101 psilocybin; Placebo capsules
- Sponsor
- MycoMedica Life Sciences PBC
- Ages
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- No
- Enrolment
- 32 people (planned)
- Start
- December 2026
- Primary completion
- September 2027
- Registry last updated
- 14 September 2026
Sites (0)
No sites listed yet. Check the registry record for updates.
How joining a trial works
- Free to take part
- Trials generally cost participants nothing for the study drug and the study visits, and some pay for travel or time. Check what a study covers on its registry page.
- Screened first
- Every study screens volunteers with questionnaires, medical history and often a physical and psychiatric check. Many people who apply are not enrolled.
- Eligibility is strict
- Common exclusions include a personal or family history of psychosis or bipolar disorder, some heart conditions, pregnancy and certain medications, which you may be asked to stop under medical supervision. Never stop a medication on your own to qualify.
- You may get a placebo
- Many trials compare psilocybin with a placebo or a low dose, and you may not be told which you had until the study ends.
- Contact the study team through the registry
- Each registry record lists the study contacts and sites. We do not republish personal emails or phone numbers; use the link on each trial page.
- Not medical advice
- This is a list of registry records, not a recommendation. Talk to your doctor before applying. Disclaimer · Safety and medications
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine, read 28 October 2026. Filter: overall status RECRUITING or NOT_YET_RECRUITING; an intervention named psilocybin, psilocin, COMP360 or CYB003. Refreshed weekly; a study's own registry page is always the current record.
Record read from ClinicalTrials.gov API v2, U.S. National Library of Medicine on 28 October 2026. All psilocybin trials