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Samson Clinical concludes enrolment for Phase III AGA trial. 17 Nov-25.
- Samson Clinical Media Releases
- Nov 17, 2025
- 2 min read
Updated: 3 hours ago
Credit: Chris Curry / Shutterstock.com.
November 17, 2025
AGA is the primary cause of hair loss, impacting up to 80% of men over the course of their lives.
(AGA).
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
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.
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.
“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.
Ellen Williamson
Samson Clinical Operations Pty Ltd
+61 404251632
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