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Hair loss breakthrough? new Under-the-Tongue pill tested in 142 men

NCT ID NCT06924632

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to take minoxidil for male pattern baldness: a tablet placed under the tongue. 142 men with moderate to severe hair loss took either the minoxidil tablet or a placebo twice daily for 24 weeks. The goal was to see if this method increases hair count and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
minoxidil sublingual tablet
What this could lead to
If it works, this could offer a new, easy-to-take option for men with hair loss that may be more effective than current treatments.
What could go wrong
This is a completed Phase 3 trial with 142 men, but results are not yet published. The new sublingual form may not work better than existing minoxidil or could have side effects like dizziness or heart issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

142 people

The number who actually took part.

Started

Jul 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • DIRECT

    East Melbourne, Victoria, 3002, Australia

  • DIRECT

    Pascoe Vale, Victoria, 3044, Australia

  • Premier Specialists Pty Ltd

    Kogarah, New South Wales, 2217, Australia

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