For decades, effective treatment options for hair loss—a prevalent aesthetic concern affecting up to 85 percent of men and 50 percent of women in their lifetimes—have been extremely limited. Since the approval of topical Minoxidil (Rogaine) in 1991 and oral Finasteride (Propecia) for males in 1997, a major breakthrough has been elusive. Now, a Connecticut-based biopharmaceutical company, Veradermics, is developing a new drug that promises to be the biggest innovation in three decades. The treatment, an extended-release oral minoxidil called VDPHL01, is currently in crucial Phase III trials, including the first-ever Phase III study for female pattern hair loss. This slow-release formulation is designed to optimize hair growth while minimizing cardiac risk, with company CEO Reid Waldman stating that early data shows “visibly noticeable regrowth” as quickly as two months.
The Current Conundrum: Limitations of Existing Treatments
Despite the universal nature of hair loss, effective and convenient treatment options have historically been scarce, leaving many patients and providers hesitant about existing solutions.
Currently, the two main clinically tested options are topical Minoxidil and oral Finasteride. While Minoxidil is effective, its topical application can be “annoying and inconvenient” for daily use. Oral Finasteride, meanwhile, is only approved for males and comes with potential hormonal side effects. Furthermore, the use of oral minoxidil is already happening, but it remains an “off-label use” because it was originally approved as a blood pressure medication, a fact that makes some providers and patients wary. The absence of an FDA-approved oral treatment for female pattern hair loss has long left a massive gap in the market. This landscape of limitation underscores the critical need for a new drug that is both easy to use and rigorously tested for safety and efficacy in all patient populations.
The Scientific Leap: Extended-Release Minoxidil
The new drug, VDPHL01, is a significant technological leap because its extended-release formulation addresses the core shortcomings of the existing off-label oral minoxidil treatment.
The original oral minoxidil was designed to act quickly to rapidly control blood pressure, meaning the majority of the drug is out of the body within two hours and falls below a critical hair threshold within four hours. This rapid delivery is not ideal for hair growth and carries an increased potential cardiac risk. VDPHL01 is an extended-release tablet developed using a proprietary hydrogel technology. The aim is to provide “consistent exposures at the hair follicle” with a slow release, ensuring the minoxidil remains available over a 12 to 24-hour period. This extended presence is expected to dramatically optimize the hair-growth benefits over time while simultaneously mitigating the potential for serious cardiac adverse events.
Promising Data: Speed, Scale, and Objectivity
Early data from the clinical trials are proving highly encouraging, showing both qualitative and quantitative results that exceed typical expectations for hair growth timelines.
The ongoing trials are comprehensive, including the first-ever Phase III study for female pattern hair loss, and deliberately include people with all hair and skin types to ensure broad applicability. Quantitatively, the Phase II results showed over 90 percent of people having a double-digit increase in the hair count. Specifically, male participants saw an average increase of 47.3 hairs per square centimeter after four months. Crucially, the qualitative results have been equally strong. CEO Reid Waldman noted that they saw a “visibly noticeable regrowth” at only month two. This is a dramatic acceleration, as clinical practices typically tell people to expect six months until any regrowth is seen. The goal is for results to be so clear that patients do not have to question their friends or stylists about a difference—the growth should be indisputable.
The Path to Approval: Rigor and Future Impact
Veradermics is moving toward FDA submission, which, if successful, will usher in a new era of highly regulated and trustworthy treatment for a pervasive, personal concern.
The company anticipates having the initial Phase III male data in the first half of 2026, with a final approval application to follow if the data remains positive. Waldman stresses the importance of this regulatory process, noting that the rigor around clinical data from an FDA trial is highly regulated to ensure accuracy, a standard that supplements do not meet. Furthermore, the company assures that they are not seeing the hormonal side effects associated with finasteride. For the 80 million people in the U.S. who experience hair loss—an issue that is described as “deeply personal, it’s deeply psychological. It is essentially universal”—the FDA approval of an oral, universally applicable treatment would be a momentous and long-overdue advancement.
