New Hair Loss Drugs Target Growth Pathways, Avoid Hormone Suppression Side Effects

Pharmaceutical and biotechnology companies are accelerating development of next-generation hair loss treatments that avoid the side effects associated with conventional hormone-suppressing drugs. Several innovative drug candidates that directly activate hair growth pathways or act locally on the scalp are entering clinical trials.

JW Pharmaceutical recently received approval from the Ministry of Food and Drug Safety for Phase 1 clinical trials of its hair loss treatment candidate JW0061. The company plans to commence clinical research at Seoul National University Hospital to evaluate the safety and tolerability of the drug in 104 healthy adults.

JW0061 is an innovative new drug candidate that directly binds to the GFRA1 receptor in hair follicle stem cells to induce hair growth. Unlike existing treatments that rely on male hormone suppression or vasodilation, it employs a novel mechanism that physiologically activates hair growth pathways. It is being developed as a topical formulation applied to the scalp that can be used by both men and women. Because it acts locally on areas of hair loss and rapidly breaks down into inactive metabolites upon systemic absorption, systemic side effects are also expected to be relatively minimal.

OliX Pharmaceuticals is developing OLX104C, a hair loss treatment utilizing RNA interference (RNAi) technology. Its mechanism suppresses androgen receptor (AR) expression, a key cause of androgenetic alopecia (male pattern baldness), thereby blocking the hormonal response that induces hair loss. The once-monthly local injection method minimizes the burden of administration and systemic side effects. The company recently completed dosing in the first patient in Phase 1b/2a trials in Australia and aims to complete Phase 1b within this year and Phase 2a by next year.

FromBio is developing a hair loss treatment based on adipose-derived stem cells. The company recently completed non-clinical toxicity testing and is on the verge of entering clinical trials.

Researchers have also developed a drug-free approach using cold atmospheric plasma paired with interleukin-2 that may offer an alternative to minoxidil and finasteride, the only two hair-loss drugs currently approved by the Food and Drug Administration. The treatment reactivates dormant hair follicles by creating a healthy immune environment around the follicle.

The researchers designed a gel-forming treatment that can be injected specifically into areas of the scalp with hair loss. They mixed hyaluronic acid with interleukin-2, a protein secreted by white blood cells. Interleukin-2 promotes the production and survival of immune cells called regulatory T cells, or Tregs. These cells reduce inflammation and promote tissue repair.

Cold atmospheric plasma, which appears as a glowing blue or purple mist at normal room temperature and pressure, provides the needed trigger. It first helps the injected liquid turn into a soft gel by providing reactive oxygen species that trigger the material to solidify under the skin. It also supplies additional reactive oxygen species that become trapped inside the gel.

The hydrogel stays in the skin for several days and slowly releases interleukin-2 and reactive oxygen species, which together boost Treg cell production. When the cells at the base of hair follicles, called the dermal papilla, are activated by Tregs, they stimulate hair follicles stuck in the telogen stage to enter the growth, or anagen, stage, resulting in stronger and faster hair regrowth.

Mice treated once every four days, for a total of four sessions over two weeks, showed better hair regeneration efficacy than those tested with minoxidil or finasteride. The researchers reported 100% fur coverage within 15 days of treatment, while daily topical application of 5% minoxidil has been reported to achieve only 35% fur regrowth after 14 days. Although mouse models are typical for assessing hair regeneration, they do not capture all the factors that contribute to genetic hair loss, medically known as androgenic alopecia, so future studies on human hair follicles are needed before clinical trials.

Currently, the mainstream approach in the hair loss treatment market is male hormone suppression, which prevents testosterone from converting into dihydrotestosterone (DHT), the hormone that causes hair loss. Drugs containing finasteride and dutasteride, currently available on the market, are representative examples. While these treatments are relatively effective at inhibiting hair loss progression, concerns over side effects such as sexual dysfunction and depression have been consistently raised. There is also a significant burden of requiring daily long-term administration. In particular, use by women is practically difficult due to restricted prescriptions stemming from risks such as fetal malformation.

The global hair loss treatment market continues its steady growth trajectory. The market, valued at approximately 8 trillion won in 2020, is projected to grow at an annual average rate of 8% and reach approximately 19 trillion won (approximately $13 billion) by 2028.