Patient-Reported Outcomes and Early Response Rates Drive Success in Extended-Release Oral Minoxidil

In a previous interview with Dermatology Times, Maryanne Makredes Senna, MD, discussed emerging data suggesting that extended-release oral minoxidil tablets may improve efficacy while minimizing cardiovascular adverse effects in patients with androgenetic alopecia (AGA).

Veradermics recently announced positive topline results from Part A of Study 302, a randomized, double-blind, placebo-controlled phase 2/3 trial evaluating VDPHL01, a proprietary extended-release oral minoxidil tablet, in 519 adult men with mild to moderate AGA. The findings position VDPHL01 as a potential first-in-class FDA-approved oral therapy for pattern hair loss in nearly 3 decades.¹

In her most recent interview, Senna, a board-certified dermatologist and hair loss specialist at Lahey Hospital and Medical Center and assistant professor of dermatology at Harvard Medical School, reviews early response rates, adverse effects, and patient-reported outcomes from the study.

Early Response as a Notable Finding

One of the most clinically meaningful signals from the study, Senna noted, is how quickly patients began noticing results. "As early as 2 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."

That early response carries practical weight beyond efficacy alone. Senna emphasized that timely visible improvement is directly tied to patient compliance, a persistent challenge in hair loss management. When patients see progress early, they are more likely to maintain long-term adherence to therapy.

Efficacy With a Favorable Safety Profile

The extended-release formulation at 8.5 mg twice daily 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 — or even sometimes better side effect profiles than what we're seeing with low-dose immediate-release oral minoxidil," Senna said.

While Senna was careful to note the absence of head-to-head trial data, she described the combination of efficacy and tolerability as 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.

Patient-Reported Outcomes

Perhaps the most striking finding for Senna was not a clinical end point, but a patient-reported one. "Up to 86% of patients were saying, 'I'm better,'" she noted. "As a hair loss clinician, that almost never happens." She described patient-perceived improvement as particularly meaningful in a field where objective photographic documentation is often the primary measure of success.

A Long-Awaited Advance

Senna placed the data in broader context, noting that no FDA-approved oral therapies currently exist for hair loss in women, despite an estimated 80 million people worldwide affected by the condition. "It has been 30 years since we have had an FDA-approved oral therapy for hair loss," she said. "There is a huge unmet need."

Further Hair Loss Research

Separately, Senna and colleagues at Lahey Hospital are currently conducting a biopsy study in treatment-naive patients with female pattern hair loss to better characterize the underlying drivers of the condition, with the goal of informing more targeted therapeutic approaches.

Clinicians interested in recommending their patients may email [email protected].

Reference

1. Veradermics’ oral VDPHL01 achieved early, consistent, and robust hair growth in positive phase 2/3 ‘302’ clinical trial in male pattern hair loss. News release. Veradermics. April 27, 2026. Accessed May 26, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-oral-vdphl01-achieved-early-consistent-and-robust