High expectations for new 'hair-loss' drugs

Competition surrounding new next-generation drugs, hair follicle stem cell·gene targeting, amid high expectations for related policies

Premature to predict performance based on early clinical trials…focus is on securing mid- to long-term safety

The technological competition within the pharmaceutical industry surrounding the hair loss treatment market is intensifying. Next-generation technologies that directly target hair follicle stem cell activation and immune·signaling pathways are emerging, overcoming the limitations of conventional treatments focused on male hormone suppression or vasodilation.

According to industry sources, pharmaceutical and biotech companies are strengthening efforts to develop mid- to long-term growth strategies based on their hair loss treatment pipelines. In particular, as President Lee Jae Myung mentioned the need to support the costs of hair loss treatment and hinted at the possibility of National Health Insurance coverage, expectations for the development of new treatments are increasing across the pharmaceutical and biotech markets.

Hair-loss treatments being developed by domestic pharmaceutical companies in Korea. JW Pharmaceutical's 'JW0061,' Hyundai Pharm's 'clascoterone' 5% solution, Chong Kun Dang's 'CKD-843,' Daewoong Pharmaceutical's 'IVL3001,' OliX Pharmaceuticals' 'OLX104C.'

Among these are companies developing new hair loss drugs, including Hyundai Pharm and JW Pharmaceutical.

Hyundai Pharm announced this month that its partner, an Italian pharmaceutical company, proved the meaningful efficacy of 'clascoterone' 5% solution for the treatment of male androgenetic alopecia in a Phase 3 clinical trial. Cosmo Pharmaceuticals had previously developed 'Winlevi Cream,' a 1% clascoterone cream for acne, through its subsidiary Cassiopea.

JW Pharmaceutical is preparing to enter the market with 'JW0061,' a new drug candidate targeting the GFRA1 receptor. JW0061 is a topical candidate that promotes hair follicle generation and hair growth by directly activating GFRA1, a receptor expressed in hair follicle stem cells. Following U.S. patent registration, preclinical studies confirmed superior efficacy in hair follicle generation and hair growth compared to existing standard treatments.

Based on these results, JW Pharmaceutical is preparing to enter Phase 1 clinical trials. Expectations are high as it is being developed as a treatment option applicable to both men and women.

Chong Kun Dang and Daewoong Pharmaceutical are leading the development of incrementally modified drugs (IMDs) for hair loss.

Chong Kun Dang is developing 'CKD-843,' an IMD that converts existing oral dutasteride medicine into a long-acting injectable administered once every 3 months. It is currently in Phase 3 clinical trials, with research aimed at reducing the medication burden and minimizing systemic side effects.

Daewoong Pharmaceutical and Inventage Lab are also developing an IMD of 'IVL3001,' a hair-loss treatment candidate being co-developed by these companies. They have modified oral finasteride into a long-acting injectable administered once a month (up to every 3 months). They recently submitted a Global Phase 2 clinical trial plan to enter Phase 3.

Cell- and regeneration-based approaches, primarily led by biotech ventures, are also active. Technologies that improve the hair follicle environment using stem cell-derived substances have drawn attention, with promising results at the research stage.

FromBIO announced this month that it completed toxicity tests reflecting the administration route and dosage for its hair loss treatment candidate using adipose-derived stem cells, confirming no significant toxic effects. Based on this, Frombio aims to enter clinical trials by the first quarter of 2027.

OliX Pharmaceuticals completed the first patient administration in a Phase 1b/2a clinical trial for its hair loss candidate 'OLX104C.' The company plans to accelerate development to finish Phase 1b this year and Phase 2a by next year. OLX104C works by reducing the expression of the androgen receptor, a key cause of androgenetic alopecia, thereby blocking the hormonal response that triggers hair loss.

Additionally, ROKIT Healthcare has applied for the world's first 'Natural Substance PBM Epigenetics' patent for a reverse-aging technology that confirmed full hair regrowth within four weeks of administration and will officially start human clinical trials in March. Beyond simple symptom improvement, it contains epigenetic reverse-aging technology that returns the microenvironment of aged hair follicles to a youthful state.

The global hair loss treatment market continues to grow due to aging populations, increased stress, and rising demand for beauty and wellness. Expectations are growing that these treatments will expand beyond the beauty sector into the chronic disease management market. Currently, minoxidil and finasteride-based treatments dominate the commercial market. They have been noted for structural limitations, such as side-effect concerns with long-term use and limited efficacy.

However, the hurdles for hair loss research are high. Due to the nature of the treatment, which requires long-term administration, rigorous safety verification is needed, and proving actual hair growth through objective indicators is also difficult. Furthermore, securing price competitiveness and whether health insurance will be applied are considered key variables for market settlement.

An industry official stated, "Since hair loss treatments require long-term administration, there is still a large unmet need for new drugs that improve upon the side effects seen in existing male hormone suppression or vasodilation mechanisms," adding, "If a treatment with an innovative mechanism appears, its market impact could be significant."

And added, "However, medicines with next-generation mechanisms have a greater burden of proving hair growth with objective indicators as well as verifying long-term safety."