Extended-Release Oral Minoxidil (VDPHL01) Shows Promise as New Treatment for Pattern Hair Loss, Announces New York Dermatologist

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HEADLINE

Extended-Release Oral Minoxidil (VDPHL01) Shows Promise as New Treatment for Pattern Hair Loss, Announces New York Dermatologist

SUMMARY

VDPHL01, a novel extended-release oral minoxidil formulation, is advancing through late-stage clinical trials and may offer a more effective and better-tolerated option for patients with pattern hair loss, according to New York dermatologist Dr. Dennis Porto.

BACKGROUND: PATTERN HAIR LOSS

Pattern hair loss (androgenetic alopecia) affects millions of men and women and remains one of the most common conditions seen in dermatology. Standard therapies such as topical minoxidil and off-label oral minoxidil have provided varying degrees of benefit, but adherence, scalp irritation, inconsistent absorption, and pharmacokinetic limitations often reduce their overall effectiveness.

Immediate-release oral minoxidil reaches high serum concentrations quickly and declines within hours, which can increase the risk of side effects and may not sustain follicular stimulation throughout the day. These limitations have contributed to demand for a more predictable systemic option.

NEW DEVELOPMENT: WHAT IS VDPHL01

VDPHL01 is an extended-release oral formulation of minoxidil designed to release the drug gradually over a full dosing interval. This approach aims to maintain therapeutic drug levels without the sharp peaks associated with traditional oral formulations.

Early clinical data suggest improved consistency of hair density gains across frontal and vertex regions, with visible improvement in as little as four months in trial participants.

Phase 3 studies are underway in both men and women with pattern hair loss, including what is expected to be the first late-stage clinical trial of an oral hair-growth therapy specifically for women.

The extended-release profile also appears to keep serum concentrations below levels associated with cardiovascular side effects, an important consideration with immediate-release minoxidil.

EXPERT COMMENTARY

“Delayed release minoxidil is a potential breakthrough for androgenic alopecia in both men and women. It has been years since a new medicine has been approved by the FDA for this condition, so dermatologists and our patients are eager for a new treatment. As dermatologists, we know that minoxidil can be a game changer for this condition, and the delayed release component allows us to potentially increase its effectiveness by maintaining its pharmacologic activity throughout the day while limiting side effects because there is no peak concentration of this medicine in the bloodstream. My colleagues and I are very enthusiastic,” said Dr. Dennis Porto, a board-certified Mohs surgeon and dermatologist in New York City.

CLINICAL SIGNIFICANCE AND OUTLOOK

If Phase 3 data confirm the earlier results, VDPHL01 could become the first newly approved systemic therapy for pattern hair loss in many years and the first extended-release oral treatment designed specifically for this indication.

This would expand the options available to clinicians counseling patients who have struggled with adherence, topical intolerance, or inadequate response to current therapies.

Long-term data on safety, durability, and ideal patient selection remain to be established, and dermatologists are monitoring the trials closely.

ABOUT DR. DENNIS PORTO

Dr. Dennis Porto is a board-certified Mohs surgeon and dermatologist and a clinical assistant professor of dermatology at Mount Sinai.

A Harvard graduate, he has authored numerous journal articles, textbooks, and book chapters and is considered a leading expert in his field.