[Edaily Reporter KIM JI-WAN ] “We shouldn’t make claims about a new hair-growth drug based solely on a photo showing hair growing on a mouse’s back. The key is how much lower the concentration is compared to existing treatments, and how quickly and effectively it stimulates hair growth.”

Kim Sang-nyeon, Director of the ORIENTBIO Research Institute (Executive Vice President, Ph.D. in Science), explained the competitiveness of the new hair-regrowth drug candidate OND-1 in an interview with E-Daily on the 14th of last month. He explained that the company did not stop at simply showing images of animals’ skin turning black and hair sprouting, but confirmed growth effects that are statistically distinguishable in human hair follicles.

ORIENTBIO(002630)The company plans to use OND-1 to target not only male-pattern hair loss but also the female-pattern hair loss market, where treatment options are relatively limited. It is positioning the fact that OND-1 is a non-hormonal candidate that acts directly on the growth signals of hair follicles—unlike existing treatments that suppress male hormones—as its key competitive advantage.

“Photos of black mice aren’t proof”…Betting on 319 human hair follicles

OND-1 is a peptide-based new drug candidate developed based on the powerful hair regrowth observed with the immunosuppressant cyclosporine A.

Cyclosporine A is a leading immunosuppressant used to prevent rejection in patients who have undergone organ transplants, such as kidney, liver, and heart transplants. It is also used to treat rheumatoid arthritis and psoriasis. In particular, it is known to cause hypertrichosis—excessive hair growth on the face or body—in some patients.

ORIENTBIO focused on hirsutism, which had been considered a side effect of cyclosporine A. The company determined that if it could reduce the immunosuppressive effects while isolating only the hair-growth-promoting effect, it could be developed into a new treatment for hair loss.

Based on the structure of cyclosporine A, the company developed OND-1 by optimizing the compound to reduce immunosuppression and toxicity while retaining its hair-growth-promoting activity. This strategy involves selectively preserving the properties involved in hair growth in the new drug candidate, rather than using cyclosporine A itself as a hair loss treatment.

ORIENTBIO believes that OND-1 is highly likely to activate the “Wnt signaling pathway,” which is crucial for hair growth. Simply put, this mechanism works by blocking the signals that prevent hair from growing, thereby transitioning weakened hair follicles back into the growth phase.

“While it is highly likely that OND-1 acts in relation to the Wnt signaling pathway, it is difficult to explain its mechanism of action based on a single pathway,” said Research Institute Director Kim. “Hair loss involves multiple contributing factors, including not only male hormones but also hair follicle stem cells, dermal papilla cells, arrector pili muscles, fibrosis, and the environment surrounding the hair follicles.”

When explaining OND-1’s competitive edge, Director Kim emphasized not the photos from mouse experiments but the test results using human hair follicles.

ORIENTBIO tested the hair-regrowth effects of OND-1 on 319 hair follicles extracted from human scalps. One hundred sixty hair follicles were assigned to the control group, while the remaining 159 were assigned to the OND-1 treatment group. The growth of these same hair follicles was then tracked daily over a four-day period. To prevent results from being skewed by hair follicles that grew well from the start being concentrated in one group, the initial growth status of both groups was adjusted to be similar.

According to the company’s data, by the fourth day of the test, the hair follicles in the OND-1 treatment group had grown an average of approximately 0.09 mm longer than those in the control group. Statistical analysis also confirmed a significant difference between the two groups. The company explained that it was not just a few hair follicles that grew significantly more; rather, the growth distribution of all hair follicles treated with OND-1 shifted upward.

Director Kim emphasized, “Since human hair follicles stop growing and enter the telogen phase 4 to 6 days after being cultured, it is not easy to confirm differences in drug efficacy over a short period.” He added, “Nevertheless, we consider it significant that we were able to confirm a statistically significant difference in just four days by tracking the same hair follicles from start to finish.”

The hair regrowth effect of OND-1 was also confirmed in animal experiments. When 0.5% OND-1 and 5% minoxidil were applied to 7-week-old female mice, respectively, the OND-1 treatment group exhibited faster and more pronounced hair regrowth. This indicates that OND-1 demonstrated more than 10 times the hair loss treatment efficacy compared to minoxidil.

However, Director Kim emphasized that one should not judge the new drug’s potential for success based solely on photos showing the mice’s skin turning black and hair growing.

“Rather than simply focusing on the fact that hair grew, we need to examine at what concentration—lower than existing treatments—the effect appears, how quickly the hair grows, and whether the difference in efficacy is significant enough to be distinguishable in clinical settings,” he said, adding, “Ultimately, the most important factor is whether we can prove its efficacy in humans.”
Overcoming

the Limitations of Topical Medications… “Aiming for Maintenance Treatment Once Every Two Months”

The biggest hurdle OND-1 must overcome is drug delivery. Due to its large molecular weight, OND-1 cannot deliver sufficient amounts of the drug to the area around the hair follicles through simple topical application alone.

ORIENTBIO previously evaluated scalp penetration and tolerability using a topical application method in a Phase 1 clinical trial in Korea. However, the company concluded that a more potent and sustained delivery method was necessary to sufficiently deliver the drug to the area around the hair follicles after passing through the scalp’s stratum corneum.

To address this, the company developed a sustained-release delivery system in which OND-1 is encapsulated in PLGA, a biodegradable polymer. It is designed so that, after the drug is delivered to the dermis via microneedles or subcutaneous injection, it is not rapidly cleared by the bloodstream but is instead slowly released around the hair follicles.

Patents for this drug delivery technology have been registered in South Korea and Japan, and the company is pursuing patent protection in the U.S., Europe, and China as well. The company is conducting preclinical studies to evaluate pharmacokinetics, toxicokinetics, residual time in the scalp, and cumulative toxicity in accordance with the modified formulation and administration method.

Director Kim stated, “We are aiming for a treatment regimen where patients receive injections every three weeks or once a month during the initial treatment phase, and visit the hospital about once every two months during the maintenance phase once hair growth has stabilized,” adding, “The key to this development is ensuring the drug remains in the area around the hair follicles for a sufficiently long time.”

The company plans to utilize its in-house primate research infrastructure to meticulously validate dosage concentrations, administration intervals, and injection volumes based on scalp area. It will subsequently target both domestic and U.S. clinical trials, though the specific timing for entering clinical trials will be determined based on the results of the preclinical studies.

Director Kim said, “We see the potential to provide a new option for hair loss patients whose condition could not be resolved through hormone suppression alone,” adding, “Our goal is to develop OND-1 into a platform-based hair regrowth drug that addresses both male-pattern and female-pattern hair loss.”

Potential Demand of 4.9 Billion People, $10.5 Billion Market… Searching for the ‘Post-Minoxidil’ Solution

Hair loss is no longer a problem limited to middle-aged Namsung. As aging, stress, and changes in lifestyle converge, the demand for treatment is rapidly increasing among women and younger demographics as well.

According to data compiled by global market research firm Grand View Research, citing the *Journal of Clinical and Diagnostic Research*, it is estimated that approximately 60% of the world’s population suffers from thinning hair. Simply applying the United Nations’ estimate of the global population at approximately 8.2 billion in 2024 suggests that about 4.9 billion people are potential candidates for hair loss concerns. However, this figure is a broad estimate of the population experiencing thinning hair, not the number of patients diagnosed with hair loss at medical facilities.

The market is also expanding. According to Grand View Research, the global hair loss treatment market is projected to grow from $10.5 billion (15 trillion won) in 2025 to $11.4 billion (16.3202 trillion won) in 2026, and to $26.8 billion (38.3668 trillion won) by 2033. The projected compound annual growth rate (CAGR) from 2026 to 2033 is 12.8%. In particular, the Asia-Pacific region is identified as the fastest-growing market.

Currently, treatments for androgenetic alopecia primarily include Namsung hormone inhibitors such as finasteride and dutasteride, as well as minoxidil. However, Namsung hormone inhibitors are difficult for women of childbearing age to use. In effect, minoxidil is the only option available to women experiencing hair loss. Given the limited number of approved treatments available to women, the company believes that the introduction of a new non-hormonal drug could reshape the market not only for Namsung hair loss but also for female hair loss.

Director Kim emphasized, “Female hair loss is intertwined with cosmetic concerns, self-esteem, and psychological stress, yet there aren’t many treatment options available,” adding, “OND-1 was not developed exclusively for women from the outset; rather, it is intended to be a new hair-regrowth drug suitable for both men and women.”