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A new generation of companies is eyeing the existing, sizeable hair loss market, hoping that better formulations and new scientific targets will finally produce treatments that are safer and more effective, as well as commercially successful.
The success of GLP-1 weight loss treatments took the world by storm, with Eli Lilly’s tirzepatide franchise
surpassing
Merck’s blockbuster Keytruda just three years after its approval for type 2 diabetes and two years after the FDA greenlit the obesity treatment Zepbound. Novo Nordisk’s Wegovy and its sister medicine Ozempic also still hold a large share of a market projected to reach nearly
$100 billion
.
An undisputed aspect of GLP-1s’ rapid uptake has been their
aesthetic use
, begging the question: What type of treatment could repeat this feat? The most obvious candidates are
alternative mechanisms for obesity
. But another drug development niche has recently broken onto the biopharma scene, reeling in serious cash in financing rounds: hair loss treatments.
In October, both
Pelage Pharmaceuticals
and
Veradermics
said they’d convinced investors of the potential of their hair loss treatments, securing $120 million and $150 million financings, respectively, to advance these assets. Though there have been breakthroughs in
immune-related hair loss
—such as alopecia areata—few treatment options exist for androgenetic alopecia, including pattern hair loss, the most common cause in both men and women.
“This is an extremely high-prevalence condition, with 80 million people in the U.S. alone,” Reid Waldman, CEO of Veradermics, told
BioSpace
, adding that it’s one people actively attempt to treat, with around 15 million people using a drug. “Despite that, there have been no new male approvals for an oral treatment in almost 30 years. There’s never been an oral approval for females,” he said. “There is a tremendous opportunity here.”
Pelage and Veradermics are hardly alone in this space. AbbVie is testing blockbuster therapy Rinvoq in
Phase III trials
for alopecia areata. Stemson Therapeutics is
developing autologous cell therapies
to create new hair follicles for permanent hair restoration, while Amplifica is
focusing on signaling molecules
that stimulate hair follicle regeneration to treat androgenic alopecia. Each of these companies is vying to be the first to bring a new treatment option through to approval, with the market in the U.S. alone for androgenetic alopecia expected to exceed
$1.4 billion by 2030
.
For Waldman, this presents a similar opportunity to the rapid rise of GLP-1 treatments: many people looking for successful weight loss treatments, but few options that meet their needs—creating a market where more effective and well-tolerated therapies can have a significant clinical and commercial impact.
A Fresh Approach to an Old Problem
The principal treatment options for people suffering from androgenetic alopecia have been limited to J&J’s Rogaine (now owned by Kenvue) and Merck’s Propecia. However, Waldman said that according to Veradermics’ research, only 9% of people are satisfied with their existing options.
Both Veradermics’ and competitor Pelage’s drug candidates could offer advantages over these current treatments. In an emailed comment, Pelage CEO Daniel Gil told
BioSpace
that PP405, a topical small molecule drug, works by targeting mitochondrial metabolism, which in
Phase II studies
was able to produce new mature hair growth from previously inactive follicles. More than 30% of participants taking PP405 saw a 20% increase in hair density while placebo counterparts saw none.
“Most treatments either target indirect drivers of hair loss, try to slow it, or mask the problem cosmetically,” Gil said. “PP405 aims to restore natural biological function by reactivating dormant hair follicles. Our approach is unique as it focuses on addressing the metabolic processes that regulate the activation of a patient’s own hair follicle stem cells.”
Unlike Pelage, Veradermics is harnessing an existing mechanism with VDPHL01—an extended-release pill version of minoxidil, leading to potential efficacy and safety benefits.
Waldman again drew parallels to the GLP-1 market, stating that these drugs had also been around for 20 years before finally being optimized to such a degree that they could effectively treat weight loss. Likewise, minoxidil was originally designed to treat high blood pressure before it was discovered that the drug also stimulated hair growth.
“The way [minoxidil, the active ingredient in Rogaine] interacts with the body is that of a blood pressure medication—it spikes quickly, and then it’s gone,” Waldman explained. “Those spikes are great for lowering someone’s blood pressure, but they’re not designed to grow hair, where you want sustained, targeted engagement at the hair follicle. With VDPHL01, we are able to blunt those peak concentrations, while giving a greater time and concentration of exposure above the hair growth threshold.”
The approach has shown mid-stage signs of efficacy. According to preliminary Phase II data
revealed in October
, along with the series C announcement, male participants treated with VDPHL01—the first cohort to be enrolled—saw an increase in the number of thickened and normally pigmented hairs after two months of treatment, with growth continuing to improve through four months of follow-up.
A Safety First Approach
According to Waldman, VDPHL01’s extended-release mechanism is also intended to address safety concerns inherent in the use of minoxidil for hair loss by reducing the peak concentration of the drug, which can lead to cardiac issues. An oral version of the drug, which is sometimes used off label for hair loss, carries an increased risk for such problems, he added.
Meanwhile, the active ingredient in Propecia, finasteride, was
the subject of a new report
, published in
The Journal of Clinical Psychiatry
in September, raising concern over increased risk of depression and suicide in men taking the medication.
Dina Strachan, a New York City board-certified dermatologist, told
BioSpace
in an email that the bottom line for any new treatment is that it has to be safe. The importance of finding new treatments for hair loss is due to the feature’s physiologic and social functions that can have broader impacts on health, psyche and social life, she added.
“There are a few options for patients who have pattern hair loss, but they don’t work well for all, or may have unacceptable side effects,” Strachan said. “Having options is always important. The efficacy, side effects, and acceptability of any treatment can vary—even issues like frequency of dosing and delivery can determine whether something is an option.”
Pelage specifically created PP405 to be a topical formulation, Gil said, because this would ensure that the concentration of the drug would remain in the skin and only a small amount would be taken up into the bloodstream. This was backed up by clinical trials, where the skin was shown to have a drug concentration a thousand times higher than in the blood. PP405 also delivered “a clean systemic safety profile,” he noted.
Both Pelage and Veradermics are planning to use the funds raised in their recent rounds to progress their assets through critical Phase III trials. Veradermics currently has three ongoing trials and expects readouts in 2026. Pelage plans to initiate a Phase III trial next year in the U.S.
“I think now we’re all clearly seeing the value of cash-pay markets and the value of these high prevalence conditions where there is great latent demand,” Waldman said, regarding the potential growth of the hair loss market. “It is hard to imagine a more exciting space to develop than androgenetic alopecia.”
