New Oral Hair Loss Pill VDPHL01 Enters Final Testing Phase

Veradermics has announced that its groundbreaking oral medication, known as VDPHL01, is entering phase three clinical trials aimed at securing approval from the U.S. Food and Drug Administration (FDA). If approved, VDPHL01 will become the first oral hair loss treatment specifically designed for both men and women in decades. The current landscape for oral hair loss medications has largely remained unchanged since the late 1990s, when finasteride was approved for men in 1997, and off-label use of oral minoxidil began in the 2010s.

This innovative drug represents a significant advancement in hair loss treatment. The biopharmaceutical company has secured financing to conduct the necessary trials for VDPHL01, which is an extended-release formulation of oral minoxidil tailored for hair regrowth. While topical minoxidil has been widely used for hair loss, oral minoxidil is only FDA-approved for hypertension treatment. As a result, its use for hair restoration has typically been classified as “off-label” despite its effectiveness.

Dr. Reid Waldman, CEO of Veradermics and a board-certified dermatologist, explains that the current formulation of minoxidil enters the bloodstream quickly, creating spikes that can be problematic for patients. “Minoxidil comes into the body very rapidly. It spikes, and then it goes away, because it wants to rapidly lower your blood pressure. Great for blood pressure; not ideal for treating hair loss,” he stated. Veradermics aims to modify the drug’s release mechanism to allow for sustained exposure at hair follicles, potentially enhancing hair regrowth while minimizing cardiovascular risks.

Significant Changes in Hair Loss Treatment

Dr. Jerry Shapiro, a board-certified dermatologist and professor at New York University, has participated in prior clinical trials for VDPHL01. He expressed enthusiasm for the potential of this new treatment, noting that it addresses a significant gap in effective options for women. “Nothing, nothing has been new in the field of androgenetic hair loss for almost three decades,” Dr. Shapiro remarked. The approval of VDPHL01 would provide a much-needed alternative to existing oral medications.

Currently available treatments like finasteride have limitations, particularly for women. While finasteride blocks DHT, a hormone linked to hair loss, it is often not prescribed to women of childbearing age due to the risk of birth defects. Moreover, side effects in men, such as erectile dysfunction, have raised concerns about its broader use. The introduction of VDPHL01 could offer a safer and more effective solution.

The phase three trials are set to involve approximately 1,500 participants with androgenetic alopecia. Dr. Ava Shamban, a board-certified dermatologist involved in the trial designs, highlighted the comprehensive nature of these studies. “This involves baseline screenings, treatment, and then potentially testing, photography, measurements, and other means for data collection weekly, monthly, bimonthly, etcetera, through the duration of the study period,” she explained.

Veradermics plans to submit a New Drug Application in 2027, with standard FDA approval timelines suggesting a potential launch in late 2028. The anticipated cost of VDPHL01 remains uncertain, though Dr. Dhaval Bhanusali, a board-certified dermatologist, expressed hope that the medication would be accessible and affordable. Currently, oral minoxidil is available for less than $15 per month, and affordability will be crucial for patient access.

As the trials progress, the dermatological community remains optimistic about the implications of VDPHL01. Dr. Shapiro believes that the drug could represent a pivotal moment in hair loss treatment. “It looks very, very promising that it works quicker in terms of the swiftness of the response and the hair density. We finally have something that really works,” he stated.

For many patients experiencing hair loss, the coming years could bring significant change. With VDPHL01 on the horizon, there is renewed hope for effective treatments that cater to both men and women, marking a new chapter in the ongoing battle against hair loss.