Hair today, still there tomorrow.
A widespread problem, hair loss affects roughly 50 million men and 30 million women, and while there’s no special potion to reverse genetic or age-related decline, some products may slow down loss and promote regrowth.
Now, an experimental treatment that’s a new spin on a classic medication is one step closer to being readily available, marking the first new pill for pattern baldness in nearly 30 years.
An oral, extended-release version of minoxidil — the active ingredient in Rogaine — successfully regrew hair in men with pattern hair loss over six months in a phase 3 trial.
According to the drug’s developer, Connecticut-based biopharmaceutical company Veradermics, the study looked at 536 men with mild to moderate hair loss.
Patients were either given a once daily 8.5 milligram dose of the experimental pill, known as VDPHL01, a twice-daily dose or a placebo.
Both the once-daily and twice-daily doses outperformed the placebo, with users taking the once-daily dose gaining an average of 28.6 hairs per square centimeter of scalp after, and 36.4 for those taking it twice daily, compared with 6.6 for patients on a placebo.
“I’m not surprised by the results, and I think it’s exciting to see positive phase 3 data for an oral treatment for hair loss,” dermatologist Pooja Shah, who wasn’t associated with the study, told Medscape Medical News.
While oral minoxidil has been used for hair loss before, the treatments were often immediate-release, meaning they were absorbed faster into the body and resulted in more side effects for some users.
A minoxidil pill also carries the risk of serious heart risks, including a fast heart rate, fluid around the heart and chest pain.
An extended-release version of minoxidil could lower peak concentration and potentially reduce certain side effects, such as dizziness or changes in blood pressure.
The drug was generally well tolerated with no treatment-related serious adverse events or cardiac adverse events.
However, those taking VDPHL01 reported more frequent swelling and unwanted hair growth than those who received a placebo.
VDPHL01 contains nearly twice as much minoxidil as the maximum recommended daily dose of 5 milligrams.
Minoxidil widens blood vessels to increase nutrient, oxygen and blood flow to budding hair follicles, extending their active growth phase while stimulating dormant follicles to become active.
These results were similar to the company’s phase 2 study involving more than 500 men, released last April.
The company hasn’t directly compared its minoxidil pill with conventional oral minoxidil, meaning it’s unclear whether their treatment offers more benefits than a less expensive generic medication.
While Veradermics is also recruiting women for its female pattern hair loss Phase 3 trial, they hope the pill will be the first FDA-approved non-hormonal oral treatment for pattern hair loss hitting shelves soon.
“Under our current plan, if our studies continue to read out positively on the timelines that we expect, and we submit and gain FDA approval, we believe it could be within the next two to three years,” Dr. Reid Waldman, a Connecticut dermatologist and CEO of Veradermics, previously told The Post.
