Eirion Therapeutics, a U.S.-based dermatology biopharmaceutical company, has announced strong early results for its topical hair loss treatment, ET-02. In a recent first-in-human clinical study, the product led to a six-fold increase in hair count compared to a placebo after just five weeks of use.
ET-02 targets androgenic alopecia, also known as age-related hair loss. The therapy is currently Eirion’s most advanced product and is being developed both as a topical and an oral treatment. The double-blind, placebo-controlled trial enrolled 24 male participants across three U.S. locations and successfully met its primary goals of safety and tolerability.
Participants were divided into three groups. The placebo group received a solution without the active ingredient. The other two groups received a topical version of ET-02 containing either 1.25% or 5% of the compound. Eirion reports that those in the 5% group showed a six-fold increase in non-vellus (thicker, terminal) hair count compared to the placebo. They also experienced a 10% improvement in hair width.
The results build on earlier preclinical data, where ET-02 outperformed minoxidil — the current standard treatment — by promoting four times more hair growth in 90 human scalp tissue grafts taken from men with androgenic alopecia.
Dr. Jon Edelson, CEO and President of Eirion, highlighted the treatment’s potential. “ET-02’s unique mechanism of action suggests it can not only restore hair but also return follicles to a normal structure and function,” he said. “We believe it could eventually prevent androgenic alopecia altogether.”
Androgenic alopecia affects about 50 million men and 30 million women in the U.S., with cases often increasing with age. While men can start experiencing symptoms as early as their teenage years, women tend to see more hair loss after menopause.
According to market research firm GlobalData, global sales of treatments for androgenic alopecia reached approximately $276 million in 2024 and are expected to grow by another $366 million by 2030. GlobalData is also the parent company of Clinical Trials Arena.
Eirion plans to begin a Phase II trial later this year. The next phase will evaluate the safety and effectiveness of ET-02 over a six-month period.
Dr. Jerry Shapiro, a hair loss specialist at NYU Grossman School of Medicine, called the results “unprecedented.” He added, “ET-02 may offer a major improvement over current treatments not just in results, but also in safety and convenience.”
Unlike hormonal treatments such as finasteride, ET-02 works through a non-hormonal pathway. Experts believe this could help avoid common side effects like sexual dysfunction, which are sometimes linked to hormone-inhibiting drugs.
Meanwhile, China-based Hope Medicine has begun enrolling patients for a Phase II trial of its monoclonal antibody drug HMI-115, which also targets androgenic alopecia. This comes as the FDA continues to allow finasteride on the market, though it now requires a warning about potential risks of suicidal thoughts.
