Efficacy & Safety of Minoxidil SL Tablets in Men With AGA

Inclusion Criteria:

• Cisgender males of at least 18 years of age (inclusive) at the time of Screening.

• In good general health in the opinion of the Investigator.

• Presence of androgenetic alopecia with hair density reduction in the centroparietalarea or vertex of the scalp classified as Norwood-Hamilton Type III vertex, IV, V orVI.

• Willing and able to attend all study visits and comply with treatment plan andrequired study procedures including scalp tattooing and hair trimming.

• Willing to maintain the same hair style, hair colour, and hair length in non-baldingareas.

• Able to comprehend and willing to sign and date a written patient informed consentform (PICF).

Exclusion Criteria:

• Norwood-Hamilton Type IIIa, IVa, and Va grades (i.e. participants must have vertexbalding).

• Use of topical minoxidil, oral minoxidil, dutasteride, finasteride, drugs withanti-androgenetic or androgenetic properties, or medications that causehypertrichosis or hypotrichosis within the 6 months prior to enrolment.

• Laser treatment of the scalp within 3 months prior to enrolment.

• History of scalp micropigmentation or hair restoration surgery.

• Use of wigs, hair extensions, hair pieces, or hair weaves at time of enrolment.

• Use of anti-hypertensive medication.

• Current participation in any other investigational drug or medical device trial,which includes administration of an investigational study medication or medicaldevice, or participation in such a trial within 3 months or 5 half-lives of theinvestigational product, whichever is longer, prior to receiving the first dose.

• History of hypersensitivity or allergies to minoxidil or any of the excipientscontained in the study medication.

• Known allergy or sensitivity to tattoo ink.

• Dermatological disorder (e.g. eczema, psoriasis) or infection affecting the targetarea (vertex or centroparietal area).

• Scalp characteristics, including scarring, that may interfere with examinations.

• Medical condition which adversely affects hair loss.

• Specific underlying conditions (e.g. cardiovascular disease, congestive cardiacfailure, cardiac arrhythmia, systemic lupus erythematosus, history ofphaeochromocytoma, pulmonary hypertension secondary to mitral stenosis, minoxidilhypersensitivity), clinically significant findings from medical history, clinicallaboratory tests, ECG, or vital signs that, in the opinion of the Investigator,could interfere with the objectives of the study or put the participant at risk.

• Moderate to severe renal or hepatic impairment.

• Hypotension (blood pressure less than 90/60 mmHg) or a history of significantsymptomatic postural hypotension.

• Untreated or uncontrolled hypertension (blood pressure greater than 150/90 mmHg, notstable on current medication for the past 3 months).

• History or evidence of hair loss other than androgenetic alopecia.

• Unwilling to comply with all study procedures and assessments.

• Scalp hair length less than ~2.5 cm

• History of alcohol and/or substance abuse, or drug-abuse disorders.

• Major surgery within 4 weeks prior to the screening evaluation, or planned surgeryprior to completion of all study procedures.

• Site employees or immediate family members of study site employees.