Balding Men Haven’t Had a New Pill Since the 1990s. That’s About to Change

An experimental hair loss treatment now looks set to become the first approved drug of its kind, following another successful large-scale clinical trial.

On Monday, the pharmaceutical company Veradermics reported the results of its double-blinded, randomized, and controlled Phase III trial for its treatment codenamed VDPHL01. Compared to placebo, significantly more people taking VDPHL01 experienced substantial hair growth, and with minimal side effects, the trial showed. Coupled with similar findings earlier this year, VDPHL01 is poised to easily secure approval as a treatment for pattern baldness from the Food and Drug Administration in the near future.

VDPHL01 is a form of minoxidil , a long-existing drug for hair loss. You might better know minoxidil by its brand name Rogaine, though it’s now widely available as a generic product sold over-the-counter.

Typically, minoxidil is used topically on the scalp to prevent or slow down hair loss, particularly from pattern baldness, also called androgenetic alopecia. Though often effective, topical minoxidil has its disadvantages. It can cause redness or irritation of the scalp; some people are unable to tolerate the messiness of a daily gel or foam; and pet owners have to be especially careful in their application, since minoxidil is toxic to dogs and cats.

In recent years, dermatologists have started to prescribe the very low-dose oral form of minoxidil for their patients instead. Though oral minoxidil is approved for high blood pressure, it can currently be prescribed for hair loss only off-label. Veradermics claims that VDPHL01 is an improved iteration of oral minoxidil. It’s intended to be a proprietary extended-release formulation of the drug, one that can provide a steady supply of the drug to ward off hair loss but at low enough levels to minimize any potential cardiovascular side effects.

In April, the company reported the successful findings of a combination Phase II/III trial testing VDPHL01. This newest study was a full-fledged Phase III trial. Both trials involved roughly 500 men with mild or moderate pattern hair loss who were given either a placebo or one of two regimens of VDPHL01 (once or twice daily).

As with the April trial, people taking VDPHL01 in this new trial fared much better hair-wise than the placebo group. About 55% in the once-daily group reported improved or much improved hair coverage on a common scale used to measure hair growth after six months of treatment, for instance, compared to only 15% of the control group; the same was true for 68% of the twice-daily group. And both treatment groups saw a substantial increase in their non-vellus hair count (vellus hair is the fine “peach fuzz” that covers most of our body) over the placebo group.

Importantly, VDPHL01 also seemed to be safe and generally tolerable, with no severe adverse events nor cardiac-related adverse events linked to the drug.