A randomized, double-blind, placebo-controlled phase 2/3 trial for VDPHL01 reported positive topline results, according to biopharmaceutical company Veradermics. The findings have the potential to position VDPHL01 as the first FDA-approved oral therapy for pattern hair loss in nearly three decades.
VDPHL01, an extended-release minoxidil tablet, is a proprietary investigational, orally available non-hormonal drug in Phase 3 development for pattern hair loss in both women and men. By leveraging extended-release technology, VDPHL01 uses a gel matrix designed to deliver a long-lasting, steady release of minoxidil for sustained absorption. This approach may help avoid the high peak concentrations of immediate-release oral minoxidil, while extending time above the minimum hair growth threshold.
Strong Foundation
Maryanne Makredes Senna, MD, a board-certified dermatologist at Beth Israel Lahey Health, assistant professor of dermatology at Harvard Medical School, and founding director of the Lahey Hair Loss Center of Excellence, where she serves as principal of the research unit, cited VDPHL01’s rapid onset as one of the study’s most clinically meaningful signals.
“As early as two months, patients started noticing a difference,” she said. “That might not be every patient, but this is a treatment that has the potential to work quickly, where you can start seeing a benefit very early on.”
This is a particularly important advantage because, in hair loss treatment, early visible gains are closely linked to long-term treatment adherence. Dr. Senna also noted that the extended-release formulation appears to offer improved efficacy without a corresponding increase in adverse effects.
“You’re able to do the extended-release minoxidil 8.5 milligrams twice a day and still have a very similar side effect profile to what we’re seeing with low-dose,” she observed. “Or even sometimes better side effect profiles than what we’re seeing with low-dose immediate-release oral minoxidil.”
Dr. Senna pointed out that while the study lacks head-to-head comparison data, the combination of efficacy and tolerability offers a strong foundation for considering this formulation as a first-line option in appropriate new patients, and as an adjunctive therapy for those already on existing regimens.
“It has been 30 years since we have had an FDA-approved oral therapy for hair loss,” she added. “There is a huge unmet need.”
Efficacy and Safety
It is a need that the dermatology industry is working to meet. Androgenetic alopecia, as pattern hair loss is known, affects an estimated 30 million women and 50 million men in the U.S. alone. While vertex pattern baldness appears to be a marker for increased risk of cardiac events, especially among men with hypertension or high cholesterol levels, its most significant impact on quality of life centers on mental health and relationships, as people with pattern hair loss often experience depression, low self-esteem, and social withdrawal.
With no new FDA-approved prescription medicines for pattern hair loss in nearly 30 years, patients have had to rely on older prescription therapies as well as over-the-counter nutraceuticals that often produce inconsistent results and contribute to dissatisfaction among patients and healthcare providers.
“Dermatology has been treating hair loss with a drug borrowed from cardiology, in a formulation never intended for our patients, at doses we arrived at informally,” said Michael Gold, MD, a board-certified dermatologist and trial investigator. “VDPHL01 is the first oral minoxidil formulation developed specifically for pattern hair loss, and now the first to generate positive Phase 3 results of efficacy and safety.”
If approved, it would also be the only FDA-approved oral non-hormonal treatment for pattern hair loss in both male and female patients. The demand is already in place, considering that the prevalence of pattern hair loss makes it the largest aesthetics market worldwide, projected to reach approximately $30 billion by 2028. Reid Waldman, MD, Chief Executive Officer of Veradermics, is confident in the trial results and the future they imply.
“We believe VDPHL01 has a potentially differentiated, generally well-tolerated clinical profile with rapid, consistent, and robust hair growth,” he declared. “We are optimistic that these results represent a defining milestone for the hair loss community, our company and investors as we advance this foundational, non-hormonal treatment approach to the clinic for the millions of people with pattern hair loss.”
