Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

This is a phase 3, multicentre, randomised, double-blinded, placebo-controlled study examining the safety and efficacy of 2.5 mg sublingual (SL) minoxidil tablets taken twice daily in the treatment of androgenetic alopecia (AGA) in men. The duration of study participation is 32 weeks including screening and safety follow up. The primary efficacy objective is to determine whether treatment with 2.5 mg SL tablets twice daily increases the number of hairs in men with AGA over 24 weeks. The primary safety objective is to evaluate the safety and tolerability of 2.5 mg SL tablets administered twice daily over 24 weeks.

NCT Number	NCT06924632
Lead Sponsor	Samson Clinical Operations Pty Ltd
Conditions	Androgenetic Alopecia, Male Pattern Baldness
Enrollment	142 participants
Start Date	2025-07-14
Primary Completion	2026-05-15 (estimated)
Study Completion	2026-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-05-18