Samson Clinical Announces Last Patient Last Visit In Pivotal Phase III Study Of Sublingual Minoxidil For Male Baldness

(MENAFN- EIN Presswire) EINPresswire / -- Samson Clinical Operations Pty Ltd (Samson) announced completion of the Last Patient Last Visit in its pivotal Phase III clinical trial evaluating low dose sublingual minoxidil in male Androgenetic Alopecia (AGA)(SAM-002).

Topline results are expected in Q2 2026.

SAM-002 is a 24-week, multicentre, double-blind, placebo-controlled study investigating a rapid dissolving 2.5 mg minoxidil tablet, administered sublingually twice daily. The primary endpoint is the mean change in the Target Area Hair Count.
Sublingual minoxidil is a novel, convenient, systemic treatment approach, designed to improve adherence to therapy. Sublingual administration reduces hepatic bioactivation of minoxidil without reducing hair follicle bioactivation. This has the potential to simultaneously improve patient safety and to maximize hair growth.

Professor Rodney Sinclair, Co-Founder and CEO of Samson, is a world-recognised expert in hair biology and hair loss, with decades of clinical and research experience.

Professor Sinclair said,“Samson and its sublingual minoxidil tablet remain on track for planned regulatory submissions for the treatment of male pattern baldness in Europe in 2026 and the US in 2029.”

The SAM-002 study is one of only a few late-stage randomised controlled trials in AGA in recent decades. While Australia has a globally recognised clinical trial infrastructure, relatively few drug development programs progress through clinical development entirely within Australia under an Australian Sponsor. Samson has completed Phase I through to Phase III clinical studies for sublingual minoxidil tablets locally.

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