Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

Phase 3, Multicentre, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Minoxidil Sublingual (SL) Tablet (2.5 mg) Twice Daily (BID) in the Treatment of Male Androgenetic Alopecia (AGA) in Adults

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia; Male Pattern Baldness
• Intervention / Treatment: Drug: Placebo; Drug: Minoxidil

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialists Pty Ltd
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • DIRECT
    • Pascoe Vale, Victoria, Australia, 3044
      • DIRECT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cisgender males of at least 18 years of age (inclusive) at the time of Screening.
• In good general health in the opinion of the Investigator.
• Presence of androgenetic alopecia with hair density reduction in the centroparietal area or vertex of the scalp classified as Norwood-Hamilton Type III vertex, IV, V or VI.
• Willing and able to attend all study visits and comply with treatment plan and required study procedures including scalp tattooing and hair trimming.
• Willing to maintain the same hair style, hair colour, and hair length in non-balding areas.
• Able to comprehend and willing to sign and date a written patient informed consent form (PICF).

Exclusion Criteria:

• Norwood-Hamilton Type IIIa, IVa, and Va grades (i.e. participants must have vertex balding).
• Use of topical minoxidil, oral minoxidil, dutasteride, finasteride, drugs with anti-androgenetic or androgenetic properties, or medications that cause hypertrichosis or hypotrichosis within the 6 months prior to enrolment.
• Laser treatment of the scalp within 3 months prior to enrolment.
• History of scalp micropigmentation or hair restoration surgery.
• Use of wigs, hair extensions, hair pieces, or hair weaves at time of enrolment.
• Use of anti-hypertensive medication.
• Current participation in any other investigational drug or medical device trial, which includes administration of an investigational study medication or medical device, or participation in such a trial within 3 months or 5 half-lives of the investigational product, whichever is longer, prior to receiving the first dose.
• History of hypersensitivity or allergies to minoxidil or any of the excipients contained in the study medication.
• Known allergy or sensitivity to tattoo ink.
• Dermatological disorder (e.g. eczema, psoriasis) or infection affecting the target area (vertex or centroparietal area).
• Scalp characteristics, including scarring, that may interfere with examinations.
• Medical condition which adversely affects hair loss.
• Specific underlying conditions (e.g. cardiovascular disease, congestive cardiac failure, cardiac arrhythmia, systemic lupus erythematosus, history of phaeochromocytoma, pulmonary hypertension secondary to mitral stenosis, minoxidil hypersensitivity), clinically significant findings from medical history, clinical laboratory tests, ECG, or vital signs that, in the opinion of the Investigator, could interfere with the objectives of the study or put the participant at risk.
• Moderate to severe renal or hepatic impairment.
• Hypotension (blood pressure less than 90/60 mmHg) or a history of significant symptomatic postural hypotension.
• Untreated or uncontrolled hypertension (blood pressure greater than 150/90 mmHg, not stable on current medication for the past 3 months).
• History or evidence of hair loss other than androgenetic alopecia.
• Unwilling to comply with all study procedures and assessments.
• Scalp hair length less than ~2.5 cm
• History of alcohol and/or substance abuse, or drug-abuse disorders.
• Major surgery within 4 weeks prior to the screening evaluation, or planned surgery prior to completion of all study procedures.
• Site employees or immediate family members of study site employees.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.5 mg Sublingual Minoxidil BID; 2.5 mg sublingual minoxidil to be taken twice a day, once in the AM and once in the PM.	Drug: Minoxidil; 2.5 mg Sublingual Minoxidil Tablet
Placebo Comparator: Placebo BID; placebo to be taken sublingually twice a day, once in the AM and once in the PM.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Non-vellus Target Area Hair Counts (TAHC)	Mean change in the vertex scalp non-vellus TAHC from baseline to week 24.	24 Weeks

Collaborators and Investigators

• Sponsor: Samson Clinical Operations Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Actual): May 15, 2026
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Hair Loss; Male Pattern Balding
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Pyrimidines; Minoxidil
• Other Study ID Numbers: SAM-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No