MELBOURNE, Australia, Aug. 6, 2025 /PRNewswire/ -- Samson Clinical (Samson), a pharmaceutical company focused on developing innovative treatments for hair loss, today announced that the first patient has been successfully randomised in its Phase 3 clinical trial in men (SAM-002). This key milestone marks the beginning of participant enrolment in the pivotal study.

Professor Rodney Sinclair, founder of Samson, commented: "Dosing our first participant is a significant step forward in bringing sublingual minoxidil to a broader patient population. We are proud of the progress to date and grateful to the trial sites, collaborators, and patients who are helping drive this important research forward. We believe this formulation has the potential to transform the standard of care for men experiencing hair loss."

The SAM-002 trial is a multicentre, randomised, controlled Phase 3 study designed to assess the safety and efficacy of sublingual minoxidil in men with androgenetic alopecia (AGA), or male pattern hair loss. Participants are being randomised in a 1:1 ratio to receive either sublingual minoxidil or placebo. Recruitment is underway at clinical sites across Australia, with enrolment expected to finish in Q3 of 2025.

Details of the trial are available at ClinicalTrials.gov (Identifier: NCT06924632).

Prof. Sinclair first coined the term low-dose oral minoxidil in his 2018 publication on the treatment of female pattern baldness.¹ Male Pattern Hair loss or AGA is the leading cause of hair loss, affecting up to 80% of men during their lifetime. Beyond its visible symptoms, AGA can significantly affect self-esteem and quality of life. Samson's sublingual minoxidil tablet is designed to provide a safe, effective, convenient and more usable alternative to existing therapies.

For more information, visit www.samsonclinical.com or email samson@samsonclinical.com.

¹ Sinclair, R. D., Female pattern hair loss: a pilot study investigating combination therapy with low-dose oral minoxidil and spironolactone. Int J Dermatol, 2018; 57: 104–109. doi:10.1111/ijd.13838

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SOURCE Samson Clinical