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

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%.