Oral Minoxidil's Steady-State Release Avoids Cardiotoxic Peaks

Jerry Shapiro, MD, professor of dermatology at New York University and director of the Disorders of Hair and Scalp program at NYU Langone Health, recently discussed topline results from Veradermics' Study '207,' evaluating extended-release oral minoxidil VDPHL01 in female pattern hair loss. Shapiro addressed the cardiac safety implications of the drug's steady-state release mechanism, the significance of the trial's patient-reported outcomes, and the benchmarks he wants to see before Study '306' data change clinical practice.¹

Steady-State Release and Cardiac Safety

Immediate-release oral minoxidil produces a peak-and-trough concentration profile, with peak levels carrying cardiotoxic potential in some patients, Shapiro said. He described treating a patient who developed pericarditis on immediate-release oral minoxidil and required discontinuation despite ongoing hair regrowth. Extended-release, steady-state dosing keeps concentrations below the cardiotoxic threshold, according to Shapiro, removing the cardiac risk tied to immediate-release peaks.²

"The point is there are cardiac side effects with this, and we want to make sure when we give this medication, the steady state doesn't go above the cardiotoxic level," Shapiro said.

Patient-Reported Outcomes as a Milestone

Shapiro called the 90% patient-reported outcome rate in Study '207' unmatched among treatments he has used for female pattern hair loss. He framed VDPHL01 as a milestone toward the first FDA-approved oral option for women, noting the last approved treatment, topical minoxidil foam, dates back decades.

"Ninety percent of the people in this phase 2 study were very happy. I think this is a milestone, and we have something new that's going to be FDA-approved oral for women," Shapiro said.

"We had nothing before. The last thing approved was decades ago, the topical minoxidil foam. Now we have something oral, something that works quickly and works very well," he said.

Benchmarks for Study '306' Readiness

Looking ahead to Study '306,' Shapiro said continued efficacy in a larger patient population, along with rapid onset of response and sustained patient-reported outcomes, would strengthen confidence in VDPHL01 ahead of broader clinical use.

"I want to see efficacy continue, which I feel confident it will happen. I want to see it in a large group of people, I want to see the rapidity of response, and I also want to see patient-reported outcomes," Shapiro said.

He noted that the cardiotoxicity risk associated with immediate-release oral minoxidil has not emerged with VDPHL01 based on data available so far, and he described himself as comfortable using the extended-release formulation as a go-to option for female pattern hair loss.

References

1. Veradermics' oral VDPHL01 delivers positive Study '207' phase 2 clinical trial results in female pattern hair loss ahead of upcoming phase 2/3 Study '306' readout. News release. Veradermics. July 15, 2026. Accessed August 12, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-oral-vdphl01-delivers-positive-study-207-phase-2
2. Waldman R, Bunick CG, Bader K. Executive insights: extended-release oral minoxidil shows optimized pharmacokinetics and potential to enhance hair growth. Dermatology Times. March 19, 2026. Accessed August 12, 2026. https://www.dermatologytimes.com/view/executive-insights-extended-release-oral-minoxidil-shows-optimized-pharmacokinetics-and-potential-to-enhance-hair-growth