Sublingual Minoxidil Enters Phase 3 Trials: A Potential Game-Changer for Male Hair Loss

Sublingual Minoxidil Enters Phase 3 Trials: A Potential Game-Changer for Male Hair Loss

By, Admin 7 August 2025

Samson Clinical just hit a major milestone. The first participant has been successfully dosed in its Phase 3 clinical trial for sublingual minoxidil—a formulation designed specifically to treat male pattern baldness.

Why This Matters

  • Androgenetic alopecia (AGA) affects up to 80% of men over their lifetime.
  • Current treatments often suffer from compliance issues and inconsistent results.
  • Sublingual delivery offers a non-invasive, fast-acting, and potentially safer alternative.

Inside the SAM-002 Study

  • Type: Randomised, controlled Phase 3 trial
  • Location: Multicentre sites across Australia
  • Intervention: Sublingual minoxidil vs placebo
  • Target: Men with AGA
  • Completion: Recruitment expected to finish by Q3 2025
  • ClinicalTrials.gov ID: NCT06924632

The Vision Behind It

Prof. Rodney Sinclair, founder of Samson Clinical, pioneered the use of low-dose oral minoxidil in 2018 for female pattern baldness. Now, he’s pushing the boundaries further:

“Dosing our first participant is a significant step forward in bringing sublingual minoxidil to a broader patient population.”

The goal: develop a formulation that’s more effective, more convenient, and better tolerated than current topical or oral therapies.

Key Benefits of Sublingual Minoxidil

  • Avoids first-pass metabolism (potential for fewer side effects)
  • Faster absorption into the bloodstream
  • More user-friendly than daily topical applications

What’s Next?

With the first participant enrolled and more sites ramping up recruitment, Samson Clinical is on track to complete enrolment by late 2025. If successful, this study could redefine the standard of care for male hair loss.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!