Samson Clinical Announces Completion of Patient Enrolment into Pivotal Phase III Clinical Trial Program for Sublingual Minoxidil in Male Pattern Baldness

MELBOURNE, Australia, Nov. 14, 2025 /PRNewswire/ -- Samson Clinical (Samson), an Australian pharmaceutical company focused on developing innovative treatments for hair loss, today announced the successful completion of recruitment in its SAM-002 Phase 3 clinical trial for androgenetic alopecia (AGA) in men (male pattern hair loss).

"The rapid enrolment in consistent with the strong unmet need among men for safe and highly effective hair loss treatments that have no undesirable impact on libido and that do not have a black box warning regarding depression and suicide," said Professor Rodney Sinclair, Founder of Samson. "This milestone brings us a major step closer to completing our clinical trial program.  If this trial is successful, sublingual minoxidil could be the first new approved medication for male pattern hair loss this century."

The SAM-002 trial is a 24-week, multicentre, randomised, placebo-controlled Phase 3 study designed to assess the safety and efficacy of sublingual minoxidil in men with AGA. Participants were randomised in a 1:1 ratio to receive either sublingual minoxidil or placebo. With recruitment now finalised, results are anticipated in mid-2026.

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

Male Pattern Hair loss or AGA is the leading cause of hair loss, affecting up to 80% of men during their lifetime. For many men, AGA is an unwelcome change, and they are highly motivated to treat it.  "We saw this in our rapid recruitment for this trial," said Professor Rodney Sinclair. "It's clear that many men are eager to address their hair loss and are open to innovative treatment options"

Prof. Sinclair coined the term low-dose oral minoxidil in his 2018 publication on the treatment of female pattern baldness.¹ Since that original publication, over a thousand scientific articles have been published in top tier medical journals, culminating in international consensus guidelines.² 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 [email protected].

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.

2. Akiska YM, Mirmirani P, Roseborough I, Mathes E, Bhutani T, Ambrosy A, Aguh C, Bergfeld W, Callender VD, Castelo-Soccio L, Cotsarelis G. Low-dose oral minoxidil initiation for patients with hair loss: an international modified Delphi consensus statement. JAMA dermatology. 2025 Jan 1;161(1):87-95.

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SOURCE Samson Clinical Operations Pty Ltd