KX-826 vs. Common Hair Loss Solutions

Category

KX-826

Minoxidil

Finasteride (Oral/Topical)

Mechanism of Action

Clear mechanism, topical use.
Competitively binds to androgen receptors (AR) in scalp hair follicles, locally blocking androgen-mediated signaling without affecting DHT levels.

Unclear mechanism, topical use.
Vasodilation to promote blood circulation in the scalp.

Clear mechanism, oral or topical use.
Inhibits the conversion of testosterone to dihydrotestosterone (DHT), thereby reducing DHT concentration in blood and tissues.

Impact on Hormone Levels

No effect on systemic hormone levels.

No direct effect.

Significantly reduces DHT, potentially causing hormonal imbalance.

Systemic Absorption

Extremely low; clinical studies confirm good safety.

Certain systemic absorption; may affect pet health.

Fully absorbed orally; topical use also poses systemic absorption risks.

Dosage and Usage

Twice daily.
60ml for one month's use; 30ml for half a month.

Twice daily.
Mandì Minoxidil Tincture 5% concentration, 60ml for one month's use.

Once daily, one tablet per use.
Topical Finasteride spray (CU-40102) by Cutia has not yet been approved for marketing.

Target Users

Suitable for both men and women (depending on indications).

Suitable for both men and women (but limited efficacy in women).

Primarily for men.
Contraindicated for women due to safety concerns.

Common Side Effects

Low incidence of adverse events; good safety profile.

Minoxidil use is associated with a pronounced shedding phase at the beginning of treatment, characterized by an initial worsening of hair loss and increased scalp greasiness. It may also induce hypertrichosis, resulting in unwanted hair growth on the face, neck, or other non-target areas of the body. Furthermore, minoxidil is highly toxic to pets, particularly cats and dogs, with multiple reported cases of poisoning and even fatalities due to accidental exposure. Therefore, it is crucial to take stringent precautions to prevent any contact with pets and ensure their safety during use.

Severe systemic side effects, including sexual dysfunction, emotional changes, fatigue, and depression.
FDA warning: Topical Finasteride formulations are unapproved and may cause serious systemic side effects similar to oral use, including sexual dysfunction, depression, and suicidal tendencies.

User Experience (Convenience & Portability)

Cosmetic product.
Oil control and refreshing.
Topical application (massage into dry scalp).

Prescription oral drug.
Only for men; women cannot use.
Topical use must avoid contact with pregnant women.

Clinical Efficacy

In a Phase II clinical trial in Chinese men with androgenetic alopecia, after 24 weeks of using KX-826 at 0.5% concentration, an average of approximately 22.73 new hairs per cm² were observed, over 15 more hairs than the placebo group. The difference was highly statistically significant (P<0.001), showing a remarkable and visible improvement.

According to clinical studies conducted by 3SBio, after 24 weeks of treatment with 5% minoxidil foam, efficacy was comparable to the internationally renowned brand ROGAINE®, with similar safety and tolerability. However, a shedding phase is common during the early stages of treatment, requiring continued use and patience.

Cutia is advancing the marketing of CU-40102 (topical Finasteride spray). In their disclosed Phase III trial in China, after 24 weeks of treatment, both total hair count and terminal hair count in the target area significantly increased compared to the placebo (P<0.05).
However, the FDA has recently warned of the potential systemic side effects of topical Finasteride products, such as sexual dysfunction and emotional changes, highlighting the need for careful long-term safety monitoring.

Product Positioning

A new generation of topical AR antagonists.
Precise, safe, and pleasant to use.

Traditional method of improving blood circulation.
Suitable for some early-stage users.

Hormone-regulating drug with significant safety controversies.