Hair loss might soon become a lot easier to treat for people who prefer a pill. An oral version of minoxidil, the active ingredient in the brand-name topical product Rogaine, has just aced a late-stage clinical trial.
On Monday morning, pharmaceutical Veradermics announced the first results of a Phase II/III trial testing out its minoxidil formulation, codenamed VDPHL01. The drug passed all of the trial’s set goals, and substantially more people taking the drug experienced hair growth compared to a placebo group. The company plans to pursue regulatory approval of VDPHL01, which it will likely win.
“VDPHL01, if approved, has the potential to transform how physicians and patients approach pattern hair loss for men,” said Veradermics scientific advisor Maryanne Makredes Senna, an assistant professor of dermatology at Harvard Medical School, in a statement released by the company.
Another option
Topical minoxidil, which is applied to the scalp, has been a standard hair loss treatment for over three decades, typically taken over-the-counter. Though topical minoxidil can be effective at preventing or slowing down hair loss, particularly pattern baldness (also called androgenetic alopecia), it has its drawbacks.
The drug can cause redness and burning on the scalp, for instance. It’s also toxic to cats or dogs, meaning pet owners have to be especially careful in how they apply and store it for safekeeping. And some people simply can’t tolerate the goopy residue it leaves behind on their head.
In recent years, dermatologists have begun using a very low-dose oral form of minoxidil for their patients instead (the oral version is sometimes given at higher doses for hypertension). Oral minoxidil isn’t approved for hair loss, though, meaning it has to be prescribed off-label. And though small studies have shown these pills can be effective, some researchers have worried about the relative quality of this data.
According to Veradermics, VDPHL01 isn’t just a repainted version of oral minoxidil. It’s supposed to be a proprietary extended-release formulation that can provide sustained and steady levels of the drug. These levels are intended to be high enough to ensure the drug’s hair growth effects, but low enough to minimize the cardiovascular side effects it can cause (when used for hypertension, a beta-blocker is typically prescribed to counteract these effects)
The latest results come from part A of the company’s “302” trial. For six months, over 500 men with mild or moderate pattern hair loss were randomized to either receive a placebo, a single 8.5 milligram dose of VDPHL01 a day, or a twice-daily dose of VDPHL01.
Both treatment groups fared better than the control group by the study’s end. Around 79% of the single-dose group saw significant hair growth (tracked via a standard scale for pattern baldness), while 86% in the twice-daily group reported the same. Meanwhile, only 36% of the placebo group saw any hair growth. Roughly half of the daily group and two-thirds of the twice-daily group reported “improved” or “much improved” hair coverage, compared to only 13% of the placebo group.
Importantly, the drug appeared to be safe and well tolerated as well. The total rate of adverse events was actually similar between the treatment and placebo groups, and no serious or cardiovascular-related events linked to the drug were reported. Around 5% of people did experience peripheral edema, or fluid retention in the lower legs or arms, though only around 1% of patients discontinued the drug as a result, the company said.
The future of hair loss
These results, barring something truly unusual, will probably secure an easy regulatory approval for VDPHL01.
If so, it would become the first new oral drug approved for pattern baldness in nearly 30 years and one likely to become a popular, front-line option for hair loss patients. Finasteride, sold under the brand name Propecia, is also taken as a pill for androgenetic alopecia, but some people can experience concerning side effects like sexual dysfunction.
“We are optimistic that these results represent a defining milestone for the hair loss community, our company and investors as we advance this foundational, non-hormonal treatment approach to the clinic for the millions of people with pattern hair loss,” said Veradermics CEO Reid Waldman.
Oral minoxidil isn’t the only thing in the near future that could change hair loss treatment for the better. Cosmo Pharmaceuticals’ topical clascoterone and Pelage Pharmaceuticals’ PP405 have also shown strong results in clinical trials to date and could reach the public in the next few years with a little luck.
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