A New Hair Loss Pill Moves Closer To FDA Approval After A Positive Clinical Trial Involving Over 500 Balding Men
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Veradermics announced positive Phase 3 results for VDPHL01, an oral minoxidil pill for pattern hair loss, showing visible improvements in male patients.
If approved, it will be the first prescription medicine for pattern hair loss in nearly 30 years. Pattern hair loss, also known as androgenetic alopecia, affects an estimated 80 million people in the US, including 30 million women and 50 million men. A new hair loss pill for follicly challenged humans has just aced its latest clinical trial and the company is now eyeing up approval from the US Food and Drug Administration.
Meet VDPHL01
Pharmaceutical company Veradermics recently announced the results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of a drug called VDPHL01. Over the course of six months, 536 men with mild-to-moderate pattern hair loss were either given an 8.5 mg pill of VDPHL01 once a day, twice a day, or a placebo.
At the end of the trial, people taking the pill once a day grew about 28.6 more hairs per square centimeter, while those taking it twice a day grew about 36.4 more hairs. People on the placebo grew just 6.6 more. The participants seemed to notice the difference, too. About 79 percent of the men who took the pill once daily and 85 percent who took the pill twice daily said they saw visible improvement, compared with 35 percent who took the placebo.
Around 56 percent of the once-a-day group and 69 percent of the twice-a-day group reported their hair coverage had "improved" or "much improved", compared with just 15 percent on the placebo. The trial found that the drug was “generally well tolerated” and no serious side effects were reported.
How does VDPHL01 work?
The secret ingredient behind VDPHL01 is minoxidil, a drug that’s already widely used to treat hair loss. Minoxidil was originally developed to treat high blood pressure, but clinical trials of the drug noted that many of the participants experienced unexpected hair growth on the scalp and elsewhere. That happy accident led researchers to repurpose minoxidil as a topical hair loss treatment that’s rubbed into the scalp.
It essentially works by dilating blood vessels and increasing the blood flow to the scalp, providing hair roots with more nutrients and oxygen to grow.
In recent years, many people worried about their hairlines have started taking a low-dose oral form of minoxidil. However, the pill is only approved for high blood pressure, so its use for hair loss is strictly “off-label.” Off the back of these latest trials, Veradermics hopes that VDPHL01 could become the go-to tablet for hair loss.
“Based on these results, we believe VDPHL01 has the potential to transform the treatment of pattern hair loss for millions of people,” Reid Waldman, Chief Executive Officer of Veradermics, said in a statement.
“I believe VDPHL01 has the potential to become the new standard of care for male pattern hair loss, if approved," added Antonella Tosti, Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery at the University of Miami.
Other trials ahead
The findings build on a previous Phase 2/3 trial of VDPHL01, announced in June this year that found equally promising results. Veradermics plans to complete a second part of that study later this year, extending the safety data on the drug for men up to 12 months.
The company is also carrying out a Phase 3 trial testing VDPHL01 for women with pattern baldness, which they hope to report in the first half of 2027.
