Samson Clinical Completes Last Patient Visit in Phase III Minoxidil Study for Male Hair Loss

Samson Clinical Announces Completion of Phase III Study for Male Pattern Hair Loss

In a significant milestone for hair loss treatments, Samson Clinical Operations Pty Ltd has completed the Last Patient Last Visit in its pivotal Phase III clinical trial designed for evaluating sublingual minoxidil as a treatment for male androgenetic alopecia (AGA). The announcement was made on May 18, 2026, marking a crucial step in the research of hair restoration therapies.

The clinical trial, known as SAM-002, has been conducted over 24 weeks, employing a multicentre, double-blind, placebo-controlled methodology. Participants received a rapidly dissolving 2.5 mg minoxidil tablet sublingually, administered twice daily. The primary goal of the study was to assess the mean change in hair count within a specific target area—an essential metric in determining the efficacy of hair loss treatments.

Sublingual minoxidil represents a novel approach in combatting hair loss, presenting a systemic treatment that enhances patient adherence to therapy. This administration method notably reduces hepatic bioactivation of minoxidil while retaining its ability to activate hair follicles, potentially improving safety profiles and promoting hair growth effectively.

Expert Commentary

Professor Rodney Sinclair, the co-founder and CEO of Samson Clinical, is globally acclaimed for his expertise in hair biology and experience in hair loss therapies. With decades of dedication to research and clinical practices, he highlighted, “Samson and its sublingual minoxidil tablet remain on track for planned regulatory submissions for the treatment of male pattern baldness in Europe by 2026 and in the United States by 2029.” His insights emphasize the innovative nature of the study and its anticipated impact on the market.

The SAM-002 trial stands out as one of the few late-stage randomized controlled trials in AGA conducted in recent years. Despite the global recognition of Australia’s clinical trial infrastructure, it is rare for drug development programs to proceed through each clinical trial phase exclusively within the Australian landscape under a local sponsor. Remarkably, Samson Clinical has advanced sublingual minoxidil tablets from Phase I through to Phase III entirely in Australia.

As the study progresses, topline results are expected to be released in the second quarter of 2026, drawing attention from industry stakeholders and researchers alike who are keen to explore the potential of this groundbreaking hair loss treatment.

With the findings from SAM-002, Samson Clinical not only aspires to redefine treatment options for male pattern baldness but also illustrates the power of innovation within the pharmaceutical landscape, aiming to fill critical gaps in the area of hair restoration.