Millions of people worldwide face the frustrating challenge of hair loss, with limited options to stop or reverse it. Currently, individuals can undergo hair transplants abroad, spend hundreds on unproven remedies, or rely on one of two FDA-approved medications: minoxidil and finasteride.
“It’s been decades since we’ve had a new treatment,” said George Cotsarelis, chair of dermatology at the University of Pennsylvania Perelman School of Medicine. “The suspense has been building, and now we have a few things that are either a variation on minoxidil or potentially something entirely new—but they’re still in the very early stages.”
Several companies, including Veradermics, Cosmo Pharmaceuticals, and Pelage Pharmaceuticals, are exploring innovative approaches to treat male- and female-pattern hair loss. These experimental therapies, featuring novel mechanisms of action, must still prove their safety and effectiveness in clinical trials.
Physicians welcome new options for patients, many of whom are surprised by the scarcity of effective treatments for the most common form of hair loss, which affects 85% of men and 40% of women by age 50. Demand has been fueled further by hair loss linked to COVID-19 infections and rapid weight loss associated with GLP-1 drugs.
Investor interest is surging as the potential market grows. Pelage Pharmaceuticals, for example, secured $120 million in funding in October. Veradermics went public this month, while Cosmo’s positive Phase 3 results for clascoterone drove its stock to nearly double.
Despite optimism, experts caution that success is not guaranteed. Yet the influx of investment signals momentum in the search for new hair-loss treatments, driven by growing acceptance of telehealth, a declining stigma around seeking treatment, and the recognition of hair care’s impact on emotional well-being.
Understanding Hair Loss
The most common form of hair loss, androgenetic alopecia, is largely genetic. In men, it is often caused by the body’s response to the hormone dihydrotestosterone, leading to balding. In women, genetic factors and hormonal changes during menopause typically result in hair thinning. Other types of hair loss include alopecia areata, an autoimmune condition treated with JAK inhibitors, steroids, or minoxidil.
While it is unclear whether hair loss is becoming more prevalent, lifestyle and dietary habits may trigger early onset, and COVID-19 has been linked to temporary shedding. GLP-1 medications such as Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy can also cause hair loss due to rapid weight reduction, particularly in patients losing 30 pounds or more within three months.
Current Treatments and Their Limitations
Minoxidil and finasteride remain the only FDA-approved treatments. Minoxidil, initially approved for hypertension in 1979, later gained approval for hair growth under the brand Rogaine. Finasteride, marketed as Propecia, was approved for men in 1997.
Both require ongoing use; discontinuation leads to hair loss within months. Side effects can be significant: oral minoxidil may cause unwanted hair growth elsewhere on the body, while finasteride can reduce libido and cause erectile dysfunction. It is not approved for women due to risks of birth defects.
Cotsarelis is exploring a method that delivers minoxidil via microneedles, based on early research suggesting scalp “wounding” can stimulate hair growth and even form new follicles.
Emerging Therapies
Several companies are advancing promising treatments:
- Cosmo Pharmaceuticals plans to submit clascoterone, a topical androgen receptor inhibitor, to the FDA this year.
- Veradermics is developing a new oral, extended-release minoxidil formulation for men and women, with Phase 2/3 data expected this year.
- Pelage Pharmaceuticals aims to start Phase 3 trials of PP405, a topical regenerative medicine targeting dormant hair follicles, in both men and women.
“These approaches reflect a long-overdue recognition that women have been underserved by existing therapies,” said Pelage CEO Daniel Gil, a former Allergan executive.
Cultural and commercial shifts also support innovation. In 2023, approximately 40 million Americans used minoxidil. Though hair-loss treatments are not typically covered by insurance, patients demonstrate willingness to spend on treatments like Botox, GLP-1s, and hair-care products. Veradermics’ strategy focuses on cash-pay, non-reimbursed products.
“The GLP-1s have really mainstreamed aesthetics,” Gil said. “I see this as Botox on steroids.”
