VDPHL01 has the potential to be the first and only extended-release oral minoxidil for women and men with pattern hair loss, a condition affecting an estimated 30 million women and 50 million men in the United States

Phase 3 trial actively enrolling for a total of more than 500 women; data expected to add to growing body of clinical evidence supporting differentiated profile of VDPHL01

Enrollment completed in ongoing VDPHL01 Phase 2 trial in pattern hair loss in both women and men with full data anticipated in 2026

Veradermics, Incorporated, a dermatologist-founded, late clinical-stage biopharmaceutical company developing potentially first-in-class therapeutics for common dermatologic conditions, today announced it has begun enrolling women in its Phase 2/3 registration-directed clinical trial for its lead investigational product, VDPHL01, marking the first such trial for an oral treatment in female pattern hair loss. VDPHL01 is an extended-release oral minoxidil treatment with the potential to be the first non-hormonal oral treatment designed specifically for hair regrowth in women and men and the first-ever oral prescription treatment for women with pattern hair loss.

First Phase 3 Trial for an Oral Treatment in Female Pattern Hair Loss Underway

The Phase 2/3 clinical trial (NCT07146022) is the only late-stage trial of its kind in women, and one of three multicenter, randomized, double-blind Phase 3 registration-directed trials of VDPHL01 in women and men with pattern hair loss. Veradermics expects to enroll more than 500 women in the United States.

Filling a Critical Need in Female Pattern Hair Loss

Pattern hair loss affects an estimated 30 million women in the United States, representing about 40% of the affected population. Despite this prevalence, and reports demonstrating that women experience a disproportionately higher psychological burden from the condition, no Phase 3 studies for an oral treatment in female pattern hair loss have been conducted in the United States to date, and there are no FDA-approved oral treatments for women.

“For too long, women have shouldered a significant physical and emotional burden of hair loss. I’ve seen their distress first-hand – managing their confidence, anxiety and shift in self-identity – while cycling through sub-optimal treatments, including over-the-counter, off-label and topical formulations that have limitations in addressing the challenges of hair regrowth,” said Maryanne Makredes Senna, M.D., board-certified dermatologist at Beth Israel Lahey Health, assistant professor of dermatology at Harvard Medical School and member of Veradermics’ scientific advisory board. “The Phase 2/3 female trial of VDPHL01 represents a major milestone for the industry and for women – providing the clinical rigor long overdue in female pattern hair loss. I've been encouraged by the early male data, and am hopeful that we are laying the foundation for an innovative, prescription oral treatment that, if approved, patients and healthcare providers can more confidently count on.”

Despite women making up approximately 85% of the U.S. aesthetics market and accounting for the majority of hair supplement purchases, no prescription treatment for pattern hair loss in women has been approved by the Food and Drug Administration in over 30 years. The only approved treatment for female pattern hair loss is topical minoxidil 5% (Rogaine^®) that has shown modest efficacy, and up to 86% of patients discontinue use, often due to its messy, cumbersome application. In the absence of prescription treatment options, women are left mostly with remedies that have not been clinically proven. VDPHL01 aims to transform the treatment landscape for women by offering a clinically validated and rigorously tested oral therapy that combines convenience, safety and robust evidence of hair growth consistency.

“Female pattern hair loss has many nuances – from differences in symptoms and presentation to underlying causes – and little has been done to advance research or understanding in this area. As a result, women have been left with few treatment options, none of which are consistently effective and only one that is clinically validated,” said Reid Waldman, M.D., Chief Executive Officer of Veradermics. “At Veradermics, we are committed to bringing scientific rigor and therapeutic innovation to an aesthetic condition where women have been underrepresented and at times even excluded from early drug development. We are incredibly excited about the potential of VDPHL01 to close the long-standing gap in care for both women and men.”

Ongoing Phase 2 Trial Female Cohort Fully Enrolled

Veradermics is also evaluating the safety and efficacy of VDPHL01 in an open-label, multi-dose Phase 2 trial in women and men with mild to moderate pattern hair loss who are not receiving any other active treatment. Enrollment in the female cohort is complete, and dosing is ongoing, with 22 women being studied over the course of 12 months. The trial’s primary endpoints include non-vellus target area hair count (thickened and usually pigmented hairs) and patient-reported outcomes assessing the perceived effectiveness of VDPHL01. The company recently announced encouraging preliminary VDPHL01 Phase 2 data in males that indicated visible and measurable hair growth as early as two months, with full results for both women and men anticipated in 2026.

For additional information about enrollment in the Phase 2/3 trial of VDPHL01 for female pattern hair loss, please visit www.phlstudy.com/female.

About Pattern Hair Loss

Pattern hair loss, also known as androgenetic alopecia, affects an estimated 80 million people in the United States (30 million women and 50 million men). Pattern hair loss can have a significant impact on quality of life, affecting an individual’s mental health and relationships. People with pattern hair loss often experience depression, low self-esteem and social withdrawal. There have been no new FDA-approved prescription medicines for pattern hair loss in nearly 30 years. In addition to prescription medicines, current treatments include over-the-counter “nutraceuticals” that produce inconsistent results and contribute to high dissatisfaction among patients and healthcare providers. The prevalence of pattern hair loss and the market demand for new treatments contribute to making this the largest aesthetics market worldwide, projected to reach approximately $30 billion by 2028.

About VDPHL01

VDPHL01 (extended-release minoxidil tablet) is an investigational, orally available non-hormonal drug in Phase 3 development for pattern hair loss in both women and men. VDPHL01 leverages extended-release technology to deliver a minoxidil product with the potential for improved efficacy and safety. The proprietary extended-release formulation utilizes a gel matrix designed to deliver long-lasting, steady release of minoxidil for sustained absorption. VDPHL01 has been shown to avoid the high peak concentrations of immediate-release oral minoxidil, while extending time above the minimum hair growth threshold to increase time for hair to grow. We believe VDPHL01 is currently the only non-hormonal oral treatment in clinical development for hair loss in both women and men.

About Veradermics

Veradermics is a dermatologist-founded, late clinical-stage biopharmaceutical company focused on turning everyday dermatology and aesthetics problems into clear, proven care. Veradermics’ lead program, VDPHL01, is an extended-release oral minoxidil tablet in Phase 3 development for the treatment of pattern hair loss — the largest aesthetics condition worldwide, affecting both women and men, with no new FDA-approved prescription therapies in more than 30 years. In addition, Veradermics is advancing a pipeline of potentially differentiated product candidates designed to address high-value dermatologic conditions with little to no proven solutions, combining proven mechanisms with innovative formulations that are designed to optimize efficacy, safety and patient convenience. For additional information, visit www.veradermics.com and follow us on LinkedIn and Instagram.

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