Samson Clinical has concluded participant enrolment for its SAM-002 Phase III clinical trial assessing sublingual minoxidil in male pattern hair loss, also known androgenetic alopecia (AGA).
The randomised, multi-centre, placebo-controlled, 24-week Phase III study aims to evaluate the efficacy and safety of sublingual minoxidil in men with this condition.
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Subjects were assigned in a one-to-one ratio to receive either a placebo or the medication. With recruitment now completed, initial results are expected to be released in mid-2026.
AGA is the primary cause of hair loss and affects up to 80% of men over the course of their lives.
For several men, AGA represents an undesirable change, and they are often motivated to seek treatment.
Samson founder Professor Rodney Sinclair said: “The rapid enrolment is 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.
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By GlobalData“This milestone brings us a major step closer to completing our clinical trial programme. If this trial is successful, sublingual minoxidil could be the first new approved medication for male pattern hair loss this century.
“We saw this in our rapid recruitment for this trial. It’s clear that many men are eager to address their hair loss and are open to innovative treatment options.”
In his 2018 publication regarding the treatment of female pattern baldness, Sinclair introduced the term low-dose oral minoxidil.
Samson’s sublingual minoxidil tablet aims to offer a convenient, safe, effective, and user-friendly alternative to current therapies.
