How Long Should You Take It... Hair Loss Medication, Now Either Spray or Injection

Global Hair Loss Market Expected to Reach 16 Trillion KRW by 2028
In Korea, Finasteride and Dutasteride Mainly Used

Yuyu Pharma Pursues FDA Approval for Dutasteride
Boryung Obtains Approval for 'Pinjuve Spray' with Reduced Side Effects
Daewoong and InventiLab Conduct Clinical Trials for Long-Acting Injectable

[Asia Economy Reporter Lee Chun-hee] Hair loss, which causes suffering for many men, is often cited as a representative example of an unmet need with a strong demand for the development of treatments. Although there are currently drugs marketed as hair loss treatments, most only provide preventive effects or halt progression rather than offering a fundamental cure, and they come with serious side effects. Accordingly, various attempts to develop hair loss treatments are ongoing domestically as well.

According to global market research firm Grand View Research on the 1st, the global hair loss treatment market is expected to grow from approximately 8 trillion KRW in 2020 to about 16 trillion KRW by 2028, representing an average annual growth rate of 8%.

Currently, the active ingredients used domestically to suppress hair loss mainly include finasteride and dutasteride for oral administration, and minoxidil for topical application.

Androgenic alopecia (male pattern baldness) occurs when testosterone, a male hormone, is converted into dihydrotestosterone (DHT) in individuals with genetic predisposition. Finasteride and dutasteride work by inhibiting 5-alpha reductase (5AR), the enzyme that converts testosterone into DHT, thereby preventing hair loss. Although the mechanism of minoxidil is not yet fully understood, it is known to promote hair growth by improving blood circulation in the applied area.

However, currently, the U.S. Food and Drug Administration (FDA) has only approved finasteride and minoxidil as effective ingredients for hair loss treatment. Dutasteride is approved for hair loss indications only in Korea and Japan. Nonetheless, it is known to be used off-label as a hair loss treatment in the U.S. and Europe.

Yuyu Pharma has revealed plans to obtain approval for its dutasteride tablets in the U.S. and Europe. Discussions with the FDA and the European Medicines Agency (EMA) for clinical trials are expected to begin next year, with clinical trials starting in 2024 and a goal to launch in the U.S. and Europe by 2026. CEO Won-sang Yoo explained, "We identified an unmet need because dutasteride is not approved as a hair loss treatment in the U.S. and Europe," adding, "Yuyu Pharma has an advantage in research and development (R&D) as we produce and sell the drug containing this ingredient ourselves."

Almirall's finasteride ingredient spray hair loss treatment 'Pinjuve'

Attempts to diversify formulations of existing treatment ingredients are also ongoing. Finasteride and dutasteride may cause side effects such as decreased sexual function, depression, and liver dysfunction. The plan is to reduce concerns about side effects by changing the formulation to affect only specific areas rather than being absorbed systemically through oral intake.

Boryung recently received marketing approval for 'Pinjuve Spray,' a finasteride-based spray hair loss medication developed by Almirall. Clinical trials showed that its efficacy and effectiveness were similar to oral finasteride, while the blood concentration was about 1/100th of that of the oral form. Sexual side effects were somewhat reduced, with 4.8% in the oral finasteride group and 2.8% in the Pinjuve group. Boryung plans to launch Pinjuve Spray in the market around the first quarter of next year.

Daewoong Pharmaceutical is collaborating with Inventi Labs and Withus Pharmaceutical to develop 'IVL3001,' a long-acting injectable finasteride formulation that extends the duration of drug efficacy and reduces dosing frequency. Stable blood drug concentration was confirmed in Phase 1 and 2 clinical trials, and the plan is to enter Phase 3 clinical trials next year. Chong Kun Dang Pharmaceutical is also conducting Phase 1 clinical trials of 'CKD-843,' a dutasteride-based injectable, at Severance Hospital.

Efforts to develop new drugs are also underway. JW Pharmaceutical is developing 'JW0061,' which utilizes the Wnt signaling pathway that regulates cell proliferation and regeneration in the skin and hair follicle stem cells. Animal experiments reportedly showed a 30% acceleration in the hair growth phase.