Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.

A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Male Participants With Androgenetic Alopecia.

This study is a Phase 3 clinical trial designed to evaluate the efficacy and safety of N1087 compared with placebo in adult men with androgenetic alopecia (male pattern hair loss).

The study will include male participants aged 18 to 60 years who have a clinical diagnosis of androgenetic alopecia classified as stages 3V, 4, or 5 on the Norwood-Hamilton scale. Participants will be randomly assigned, in a 2:1 ratio, to receive either N1087 or placebo. Neither the participants nor the study team will know which treatment each participant receives.

The study treatment will be taken orally once daily for a total of 24 weeks. During the first 8 weeks, the dose will be gradually increased (titration period) up to a maximum tolerated dose, not exceeding 5 mg. Participants will then continue treatment at the maximum tolerated dose for the remaining 16 weeks.

The main purpose of the study is to assess whether oral minoxidil improves hair growth. The primary outcome measure is the change from baseline in the density of non-vellus hairs in a defined target area of the scalp (vertex) after 24 weeks of treatment, measured using digital phototrichogram analysis.

Secondary objectives include evaluating changes in hair density at earlier time points, hair thickness, the proportion of terminal hairs, clinical improvement assessed by the investigator, quality of life related to hair loss, and participant satisfaction with treatment.

The safety and tolerability of oral minoxidil will also be evaluated by monitoring adverse events, vital signs, and events of special interest throughout the study. An independent Data and Safety Monitoring Committee will oversee participant safety during the trial.

This is a multicenter study conducted in Brazil, with approximately 372 participants expected to be enrolled.

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%.