Samson Clinical has reached a critical milestone by completing patient enrollment in its pivotal Phase III clinical trial focusing on sublingual minoxidil for male pattern baldness, also known as androgenetic alopecia (AGA).

This achievement is a major step toward bringing a new, convenient, and potentially safer alternative to existing hair loss therapies to the market.

The study, a 24-week, multicentre, randomised, placebo-controlled Phase 3 trial, will evaluate the safety and effectiveness of the under-the-tongue tablet in treating male-pattern hair loss. With enrolment now locked, results are expected by mid-2026.

Professor Rodney Sinclair, Samson Founder and a leading figure in hair-loss research, said the speed of recruitment underscores a powerful unmet need.

"Men want treatments that work without affecting libido and without black-box warnings on depression or suicide,” Sinclair said. “This milestone brings us a major step closer. If this trial succeeds, sublingual minoxidil could become the first new approved medication for male pattern hair loss this century.”

AGA affects up to 80 per cent of men across their lifetime and remains one of the most common and most psychologically challenging forms of hair loss. Sinclair said the trial’s rapid sign-ups reflect a deep appetite for better options.

Prof Sinclair first popularised low-dose oral minoxidil in 2018, sparking a wave of clinical research and ultimately international treatment guidelines. Samson’s sublingual tablet aims to deliver a safer, more convenient alternative to existing therapies.