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New hair loss drug enters final testing phase

NCT ID NCT07516561

Disease control Sponsor: Apsen Farmaceutica S.A. Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a new topical drug called APSMNF for male pattern baldness. About 336 men aged 18 to 60 will apply it twice daily for 24 weeks. Researchers will measure changes in hair density using a special camera and track any side effects.

What this could mean

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

Active substance
APSMNF (a topical drug applied to the scalp)
What this could lead to
If it works, this could offer a new treatment option for male pattern baldness, helping to regrow hair and slow further loss.
What could go wrong
This is an early Phase 3 trial, so results are not yet known. The treatment may not work better than existing options, and side effects like skin irritation are possible.

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

About 336 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

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 to 60 years

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: * Men aged 18 to 60 years with a clinical diagnosis of androgenetic alopecia ; * Participants who use an acceptable contraceptive method, or who declare that their partner uses an acceptable contraceptive method, according to the protocol, and who agree to use it throughout the study period. Exclusion Criteria: * History of allergic reactions to any of the active ingredients or to any of the ingredients of teh formulation; * Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years; * Participants with conditions that may affect hair growth or with underlying conditions that cause hair loss, such as a diagnosis of alopecia areata, fibrosing or cicatricial alopecia, or telogen effluvium, the latter being present at the time of screening; * Participants with concomitant inflammation or other dermatological conditions of the scalp, such as moderate or severe psoriasis or seborrheic dermatitis, and/or active infection and/or keloid formation in the area of alopecia;

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Conditions

The condition(s) this trial relates to.

alopecia androgenetic alopecia

As listed by the trial registrant

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

Alopecia, androgenetic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinica Geral Investiga Ltda

    Campinas, São Paulo, Brazil

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