Veradermics Completes Enrollment in Second Pivotal Phase 3 Clinical Trial of VDPHL01 for Male Pattern Hair Loss
- This marks the completion of enrollment of all male Phase 3 studies of VDPHL01 in pattern hair loss, with approximately 1,000 male patients enrolled across studies
Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions, today announced completion of enrollment in its second Phase 3 registration-directed clinical trial evaluating VDPHL01 for the treatment of male pattern hair loss. Following the previously announced completion of enrollment in Veradermics’ first Phase 2/3 trial, this milestone marks the completion of enrollment across both Phase 3 clinical trials of VDPHL01 in males, encompassing more than 1,000 participants.
VDPHL01 is an oral, extended-release (ER), formulation of minoxidil designed to maximize minoxidil’s impact on hair restoration while improving tolerability by minimizing the risk of cardiac side effects. VDPHL01’s proprietary extended-release formulation utilizes a gel matrix to deliver long-lasting, steady release of minoxidil to hair follicles over time. This release profile is intended to enable fast, consistent and intense hair growth, without inciting concentration spikes above minoxidil’s identified cardiac activity threshold, the plasma level at which cardiac effects are first observed.
Completing enrollment across both Phase 3 trials in men marks a significant milestone for Veradermics and an important moment in the development of VDPHL01,” said Reid Waldman, M.D., Chief Executive Officer of Veradermics. “This achievement reflects the commitment of the investigators, study participants, and clinical teams who made it possible to execute a rigorous, registration-directed program in a condition that has seen limited therapeutic innovation for decades. With enrollment in our male trials now complete, we are advancing towards the first NDA filing for an oral treatment for pattern hair loss in nearly 30 years.
The ‘304’ Phase 3 male trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of VDPHL01 at two dose regimens (8.5 mg once-daily and twice-daily) over 52 weeks in 536 male participants with mild-to-moderate pattern hair loss. The co-primary endpoints are change in non-vellus hair count and patient-reported hair coverage benefit at 24 weeks.
Veradermics’ first Phase 2/3 trial in males completed enrollment in 2025 with topline data anticipated in the first half of 2026. Preliminary data from a separate Phase 2 trial in males, announced in 2025, indicated visible and measurable hair growth following VDPHL01 treatment. Veradermics is actively recruiting participants for its Phase 2/3 trial in females (NCT07146022) with pattern hair loss.
About Veradermics
Veradermics is a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics to address pervasive treatment challenges in highly prevalent aesthetic and dermatological conditions. Veradermics aims to develop a focused portfolio of aesthetic dermatology product candidates targeting high-prevalence dermatologic conditions, with potential selective development of medical dermatology product candidates. Its lead program, VDPHL01, is being developed as an oral, non-hormonal treatment for men and women with pattern hair loss, to reduce the barriers to wide adoption of chronic hair loss therapy and potentially transform pattern hair loss treatment. VDPHL01 is an oral, extended-release formulation of minoxidil, a proven hair growth agent, designed to maximize minoxidil’s impact on hair restoration while minimizing the risk of cardiac activity.
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.
If approved, VDPHL01 would be the only FDA-approved oral non-hormonal treatment for PHL in both male and female patients.VDPHL01 is protected by a broad library of patents and patent applications related to the key innovations of VDPHL01. The earliest expiring patent term is 2043.
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 it the largest aesthetics market worldwide, projected to reach approximately $30 billion by 2028.
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