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New hair loss drug for women enters final testing phase

NCT ID NCT07303322

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests whether an oral solution called N1087 can help women with female pattern hair loss regrow hair. About 372 women aged 18 to 60 will receive either N1087 or a placebo daily for 24 weeks. The study measures changes in hair density and thickness using scalp photos.

What this could mean

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

Active substance
N1087 (oral solution)
What this could lead to
If it works, this could offer a new daily treatment option to help women with thinning hair regrow thicker hair.
What could go wrong
This is an early Phase 3 trial, so results are not yet known. The drug may not work better than placebo, and side effects 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 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

Aug 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

Female 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: * Female participants aged ≥18 years and ≤60 years at the time of signing the informed consent form. * Presentation of female pattern hair loss in stages 2 to 4 of the Sinclair scale (Women's Alopecia Severity Scale - WASS), based on the Investigator's clinical examination. * Absence of specific treatment for female pattern hair loss (FPHL) in the last 6 months or history of specific treatment for FPHL lasting ≤30 days in the last 6 months. Participants currently using specific treatment for FPHL or with prior use lasting \>30 days in the last 6 months must complete a 3-month washout period before the Randomization Visit (RV). * Willing to agree to all procedures and assessments required by the clinical trial, including a permanent tattoo applied to the scalp and shaving of the target area. * Willing to maintain hair style, length, and color throughout the study. * Willing to maintain consistent use of hair care products and general hair care routine during the entire study. Exclusion Criteria: * Participant presenting other causes of alopecia, such as: alopecia areata, scarring alopecia, traction alopecia, nutritional deficiency, monilethrix, trichotillomania, trichothiodystrophy, chemotherapy-induced alopecia. * Participant who experienced telogen effluvium in the last 6 months, such as after childbirth, infection, intense stress. * Participant presenting other dermatological conditions on the scalp, such as: seborrheic dermatitis, psoriasis, eczema, scalp mycosis. * Participant presenting signs or symptoms of hyperandrogenism, such as: hirsutism, moderate to severe acne. * Participant with previous diagnosis of hormonal disorders, such as: polycystic ovary syndrome, ovarian or adrenal tumors. * Participant with previous diagnosis of pituitary disorders, such as: prolactinoma, panhypopituitarism. * Participant presenting uncontrolled thyroid disease. * Participant with previous diagnosis of autoimmune diseases or collagen disorders, such as: systemic lupus erythematosus, dermatomyositis, scleroderma. * Participant in use of hormonal therapy initiated or changed in the last 6 months. * Participant who has received an organ transplant. * Participant who underwent physical treatments for hair loss in the last 6 months, such as: microneedling, laser, platelet-rich plasma. Note: in this case, the participant must complete a 3-month washout period. * Participant with history of hair transplant. * Participant who uses hair extensions. * Participant presenting severe uncontrolled hypertension (systolic blood pressure \[SBP\] \>180 mmHg or diastolic blood pressure \[DBP\] \>110 mmHg). * Participant presenting confirmed orthostatic hypotension (sustained reduction of SBP ≥20 mmHg or DBP ≥10 mmHg within 3 minutes after standing). * Participant presenting arterial hypotension (SBP \<90 mmHg or DBP \<60 mmHg). * Participant with previous diagnosis or suspected pulmonary hypertension associated with mitral stenosis. * Participant with previous diagnosis of acute myocardial infarction. * Participant with previous diagnosis or suspected pheochromocytoma. * Participant presenting history of peripheral edema, lymphedema, or ascites. * Participant with history or risk factor for pericardial effusion. * Participant with previous diagnosis of other moderate to severe cardiovascular, renal, or hepatic diseases. * History of any malignancy in the last 5 years, except successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin. * Participant in current use of potent vasodilators, such as: hydralazine and isosorbide. * Participant with known allergy or hypersensitivity to minoxidil or any component of the formulation. * Participant presenting hair styles that, in the Investigator's opinion, prevent study assessments, such as: permanent braids, dreadlocks, box braids, nagô. * Participant who is pregnant, breastfeeding, or has potential to become pregnant and does not agree to use a contraceptive method during the clinical trial. * Participant presenting any clinically significant condition that, in the Investigator's opinion, makes the participant unsuitable for participation in the trial. * Participant who has participated in clinical trial protocols in the last 12 months, unless the Investigator considers there may be direct benefit.

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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

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

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