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New pill could regrow hair in balding men

NCT ID NCT07529977

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a daily oral minoxidil pill (N1087) can help regrow hair in men with male pattern baldness. About 372 men aged 18 to 60 with moderate hair loss will take either the drug or a placebo for 24 weeks, with the dose slowly increased. The main goal is to see if hair density improves on the scalp.

What this could mean

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

Active substance
oral minoxidil (N1087)
What this could lead to
If it works, this could offer a convenient daily pill to regrow hair in men with common baldness, potentially reducing the need for topical treatments.
What could go wrong
This is a Phase 3 trial, but it's still early to know if oral minoxidil works better than placebo for hair growth. Side effects like dizziness or unwanted hair growth are possible, and results may not apply to all men.

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 372 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Oct 2028

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: * Male participants aged 18 to 60 years at the time of signing the informed consent form. * Clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 according to the Norwood-Hamilton scale, based on the investigator's clinical assessment. * No specific treatment for androgenetic alopecia in the last 6 months, or history of specific treatment for androgenetic alopecia for up to 30 days within the last 6 months. * Willingness to comply with all study procedures and assessments, including permanent scalp tattooing and shaving of the target area. * Willingness to maintain hairstyle, hair length, and hair color throughout the study. * Willingness to maintain consistent use of hair products and general hair care routine throughout the study. * Global scalp photograph obtained at Screening Visit validated centrally prior to randomization. Exclusion Criteria: * Presence of other causes of alopecia, such as alopecia areata, scarring alopecia, traction alopecia, nutritional deficiency-related alopecia, monilethrix, trichotillomania, trichodystrophy, or chemotherapy-induced alopecia. * History of telogen effluvium within the last 6 months. * Presence of other dermatological conditions affecting the scalp, such as seborrheic dermatitis, psoriasis, eczema, or fungal infections. * Clinically relevant uncontrolled endocrine disorders that may affect the hair cycle. * Uncontrolled thyroid disease. * History of autoimmune diseases or collagen vascular diseases. * Use of testosterone, its analogues, anabolic steroids, or other systemic androgen therapies within the last 6 months. * History of organ transplantation. * Physical treatments for hair loss within the last 6 months, such as microneedling, laser therapy, or platelet-rich plasma. * History of hair transplantation or use of hairpieces. * Severe uncontrolled systemic arterial hypertension or hypotension. * History of significant cardiovascular disease, including myocardial infarction, unstable angina, or congestive heart failure (NYHA class III or IV). * History or suspicion of pulmonary hypertension associated with mitral stenosis or pheochromocytoma. * History of peripheral edema, lymphedema, ascites, or pericardial effusion. * Resting tachycardia (heart rate ≥100 bpm). * Moderate to severe renal, hepatic, or cardiovascular disease. * History of malignancy within the last 5 years, except for successfully treated non-metastatic basal or squamous cell carcinoma of the skin. * Current use of potent vasodilators or other prohibited medications. * Known allergy or hypersensitivity to minoxidil or any component of the formulation. * Hairstyles that may interfere with study assessments, such as permanent braids or dreadlocks. * Participants with reproductive potential whose partner does not agree to use effective contraception during the study. * Participation in another clinical trial within the last 12 months. * Clinically significant laboratory abnormalities at randomization, including HbA1c ≥8%, estimated glomerular filtration rate \<45 mL/min, elevated liver enzymes (\>2× ULN), abnormal thyroid-stimulating hormone levels, clinically significant ECG abnormalities, hemoglobin \<13 g/dL, or hematocrit \<39%.

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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.

How to take part

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  1. The official record

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