First Patient Randomised in Samson Clinical Phase III Sublingual Minoxidil Trial for MalePattern Hair Loss (Androgenetic Alopecia)

Credit: Chris Curry / Shutterstock.com.

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

Ellen Williamson

Samson Clinical Operations Pty Ltd

+61 404251632

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