Samson Clinical has achieved a significant milestone in hair loss treatment development by successfully randomizing the first patient in its Phase III clinical trial evaluating sublingual minoxidil for male pattern hair loss. The Australian pharmaceutical company announced this key development on August 6, 2025, marking the beginning of participant enrollment in the pivotal SAM-002 study.
Trial Design and Objectives
The SAM-002 trial represents a multicentre, randomised, controlled Phase 3 study designed to assess the safety and efficacy of sublingual minoxidil in men with androgenetic alopecia (AGA). Participants are being randomised in a 1:1 ratio to receive either sublingual minoxidil or placebo. Recruitment is currently underway at clinical sites across Australia, with enrolment expected to finish in Q3 of 2025.
Professor Rodney Sinclair, founder of Samson Clinical, emphasized the significance of this milestone: "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."
Clinical Need and Market Impact
Male pattern hair loss represents a substantial medical need, affecting up to 80% of men during their lifetime as the leading cause of hair loss. Beyond its visible symptoms, AGA can significantly affect self-esteem and quality of life, highlighting the importance of developing effective treatment options.
Samson's sublingual minoxidil tablet is designed to provide a safe, effective, convenient and more usable alternative to existing therapies. This approach builds on Professor Sinclair's pioneering work in the field, as he first coined the term low-dose oral minoxidil in his 2018 publication on the treatment of female pattern baldness.
Regulatory and Development Timeline
The trial details are publicly available at ClinicalTrials.gov under the identifier NCT06924632, providing transparency for the medical community and potential participants. The completion of enrollment by Q3 2025 positions Samson Clinical to advance this novel formulation through the regulatory pathway for male pattern hair loss treatment.
The sublingual delivery method represents an innovative approach to minoxidil administration, potentially offering improved patient compliance and therapeutic outcomes compared to traditional topical applications. This Phase III study will provide crucial efficacy and safety data needed for regulatory approval considerations.
