We might be on the verge of a breakthrough treatment for pattern hair loss following clinical testing of a new oral medication called VDPHL01.
The success of the phase II/III clinical trial puts the treatment’s developer, Veradermics, in a strong position to deliver the first new effective hair-loss drug to the US market in nearly 30 years.
“Based on the results of the ‘302’ trial, VDPHL01, if approved, has the potential to transform how physicians and patients approach pattern hair loss for men,” says Dr Maryanne Makredes Senna, Assistant Professor of Dermatology at Harvard Medical School and member of Veradermics’ scientific advisory board.
“I believe that an oral therapy that has improved hair loss in the eyes of nearly 80% of patients and investigators, was generally well tolerated in trials and sits in a class that dermatologists are already comfortable prescribing, has the potential to transform the treatment landscape for male pattern hair loss,” she adds.
In a study involving 519 males, 79.3% of volunteers who received one daily dose and 86% of participants who received two doses each day reported an improvement in hair coverage, compared with 35.6% taking a placebo.
VDPHL01 resulted in significant improvements in hair growth after six months, with patients on the two-a-day dose achieving growth of 33 hairs/cm² from baseline compared with 7.3 hairs/cm² in the placebo cohort.
Importantly, the drug was also well tolerated throughout this period, and at the six-month mark it had a similar discontinuation rate among those taking the drug as those taking the placebo.
If approved, VDPHL01 may become the first non-hormonal pill for pattern hair loss to get a green light from the Food and Drug Administration (FDA), treating a common condition that affects an estimated 80 million adults in the US alone.
“VDPHL01 is the first oral minoxidil formulation developed specifically for pattern hair loss, and now the first to generate positive Phase III results of efficacy and safety,” says trial investigator Michael Gold, M.D.
The positive results at this stage of testing mean there are a lot of eyes on its second Phase III male trial – Study 304 – which is expected to deliver results in the second half of 2026. The company has also recruited women for a dedicated female pattern hair loss Phase II/III trial, or “Study 306”.
Essentially, VDPHL01 (extended-release minoxidil tablet) is an oral extended-release drug that so far has demonstrated it broadens the window of efficacy for hair growth.
Now, VDPHL01 has the potential to be the only FDA-approved oral non-hormonal treatment for pattern hair loss across the board.
“VDPHL01 is an oral, extended-release proprietary formulation of minoxidil, a proven hair growth agent, designed to maximize minoxidil’s impact on hair restoration while minimizing the risk of cardiac activity,” the company described in a statement.
Source: Veradermics
Fact-checked by Mike McRae
