Extended-Release Oral Minoxidil Tablets Show Potential for Enhanced Hair Growth in Androgenetic Alopecia

New data on investigational extended-release oral minoxidil tablets may signal a meaningful advancement for androgenetic alopecia (AGA), according to Maryanne Makredes Senna, MD, a board-certified dermatologist and hair loss specialist at Lahey Hospital and Medical Center and assistant professor of dermatology at Harvard Medical School.

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

Rethinking Oral Minoxidil Delivery

Senna emphasized that currently used oral minoxidil formulations were originally developed for hypertension, not hair loss treatment.

“The minoxidil that we’re using now for immediate release was not designed to treat hair loss,” Senna said. “It was designed to be a quick-on, quick-off therapy for people who had malignant hypertension.”

According to Senna, the pharmacokinetics of immediate-release minoxidil create therapeutic limitations in dermatology practice. Because the drug is rapidly cleared—typically within several hours—clinicians may encounter a ceiling effect when escalating doses to improve efficacy.

“We’re only able to get so much efficacy from certain doses of minoxidil that don’t lead to cardiovascular side effects,” she explained, citing palpitations, blood pressure changes, edema, and electrocardiogram abnormalities as potential concerns associated with higher dosing.

She added that increasing doses of immediate-release oral minoxidil may not proportionally improve hair growth outcomes because the medication “is not hanging around the hair follicle long enough.”

Extended-Release Formulation May Improve Therapeutic Window

Senna noted that the rationale behind the investigational extended-release formulation is to prolong follicular exposure while maintaining lower systemic blood concentrations.

“With an extended-release formulation, you’re able to have the benefits of minoxidil orally hanging around the hair follicle for long durations of time while still staying well below the threshold in the blood that can lead to cardiovascular side effects,” she said.

At the 2026 American Academy of Dermatology (AAD) Annual Meeting, Veradermics’ CEO, Reid Waldman, MD, discussed data presented at the meeting, which also addressed the efficacy of the extended-release tablet.²

“If you keep minoxidil at the follicle at optimal levels for a longer period of time, you have the potential to drive the formation of the true active that drives hair growth,” Waldman said in an interview at AAD.

The emerging efficacy data, she added, appear clinically meaningful when compared with currently available therapies, although she stressed the study was not a head-to-head comparison against topical minoxidil or oral finasteride.

“When we look at the results in total area hair counts from this study, the number of hairs that we’re getting per centimeter squared is about 1.5 times our best options available to us right now,” Senna said.

Patients in the once-daily and twice-daily arms of Part A of Study 302 achieved mean increases in non-vellus TAHC of 30.3 and 33.0 hairs/cm², respectively, compared to 7.3 hairs/cm² in the placebo group (p<0.0001 for both). On the AAIRS, 79.3% of once-daily patients and 86.0% of twice-daily patients reported any hair improvement, versus 35.6% in the placebo arm. Notably, 48.4% of once-daily and 62.9% of twice-daily patients achieved the higher threshold of "improved" or "much improved" ratings, compared to 13.4% for placebo.¹

Potential Role in Future AGA Management

Senna suggested the investigational therapy could potentially expand the limited therapeutic armamentarium currently available for hair loss management.

“Hopefully, we’ll have something that can either be used as an adjunct with the other things that we already have, and something that’s going to be able to provide the best outcomes that we have to date,” she said.

She noted, however, that future clinical use will ultimately depend on regulatory decisions and approved dosing guidance.

Disclosure: Senna is a paid scientific advisory board member for VDPHL01.

References

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 14, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-oral-vdphl01-achieved-early-consistent-and-robust
2. Veradermics announces presentations on VDPHL01 and patient experiences with pattern hair loss at 2026 American Academy of Dermatology Annual Meeting. News release. Veradermics. March 18, 2026. Accessed May 14, 2026. https://ir.veradermics.com/news-releases/news-release-details/veradermics-announces-presentations-vdphl01-and-patient