A new version of a popular hair-growth drug has led to a dramatic regrowth of hair, new trial results show.
Connecticut-based Veradermics has developed a turbocharged-like, extended-release oral form of Minoxidil, which it says delivers twice the amount of the drug over 12 hours compared to the standard version.
In a study involving more than 500 men, researchers found those who took the experimental drug once or twice daily for six months gained between 30 and 33 more hairs per square centimeter of their scalp.
Men in the placebo group, who did not receive the active drug, saw just seven more hairs per square centimeter over the same period.
Between 79 and 86 percent of men who took the experimental medication also said they had visible improvements in their hair, compared to 35 percent on the placebo.
Researchers said those on the drug saw results within just two months of starting on it.
Veradermics said the results suggest their drug, called VDPHL01, has the potential to become the first FDA-approved oral pill for hair loss in nearly 30 years.
Dr Michael Gold, a dermatologist and investigator in the trial, said: ‘Dermatology has been treating hair loss with a drug borrowed from cardiology, in a formulation never intended for our patients, at doses we arrived at informally.
The above was among the best results from the experimental form of minoxidil that was tested in the trial
‘VDPHL01 is the first oral minoxidil formulation developed specifically for pattern hair loss, and now the first to generate positive Phase 3 results of efficacy and safety.’
Hair loss is a common issue in the US. Among men, an estimated 40 percent experience some form of hair loss by age 40, while 95 percent experience it at some point in their lifetimes. For women, about a third experience some form of hair loss in their lifetimes.
Americans spend an estimated $3.5billion every year on supplements, surgeries and drugs that doctors say can slow hair loss.
Current treatments include hair transplants, alongside the drugs finasteride – taken orally and used to prevent further hair loss – and minoxidil – taken orally or topically, and which can help to prompt hair regrowth.
At present, minoxidil is approved by the FDA in doses up to 5 milligrams (mg), with most men starting at 1mg and working upward as needed. It must be prescribed by a doctor to be used.
For comparison, the experimental drug contains 8.5 mg of minoxidil.
In the study, which was a Phase 2/3 trial of the experimental treatment, VDPHL01 was compared against a placebo, or inactive drug.
Some studies suggest, however, that the drug may be more powerful than minoxidil already on the shelves. A previous study from 2024 found that after six months on 5mg of oral minoxidil, patients gained 23.4 hairs per centimeter on their scalp.
The above was among the best results from the experimental form of minoxidil that was tested in the trial
The form of minoxidil tested by the researchers is extended-release and contains 8.5 milligrams (mg) of minoxidil (stock image)
Others, however, suggest the situation is not as clear-cut.
A 2022 meta-analysis found that for every 1mg increase in the dose of minoxidil, about nine more hairs grew on every one centimeter of the scalp. It also warned that every 1mg rise led to a five percent higher risk of cardiovascular side effects such as irregular heart beats or high blood pressure.
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A 2020 study on 30 Thai men who took 5mg of minoxidil for six months found that they had 35.9 more hairs per square centimeter on their scalp at the end of the study.
Veradermics said their drug was generally well tolerated and there were no treatment-related serious reactions or cardiac events recorded.
Overall, about 40 percent of patients in both the experimental and placebo groups recorded at least one adverse event.
About five percent of patients who received the experimental minoxidil had peripheral edema, or swelling of tissues in the legs, ankles, feet or hands. A similar number also experienced hypertrichosis, or hair growth in other areas besides the head.
Four of the 346 patients who took the experimental minoxidil discontinued its use because of the side effects.
On current prescription labels, doctors warn about seven percent of patients prescribed minoxidil experience edema, while hypertrichosis is recorded in 80 percent of patients within three to six weeks of starting treatment.
Minoxidil works by relaxing blood vessels and boosting blood flow to the scalp and other areas, which boosts the nutrient and oxygen supply to follicles – helping them to trigger hair regrowth.
More than 80 percent of men who used the drug said they noted an improvement in their hair loss
Phase 3 trials and FDA approval will be needed before VDPHL01 can hit shelves, which is likely still some time away. The company did not say how much their new drug might cost.
Dr Maryanne Senna, a dermatologist and member of Veradermics’ scientific advisory board, said: ‘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.
‘I believe that an oral therapy that has improved hair loss in the eyes of nearly 80 percent 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.’
Veradermics said their results show the new drug has the potential to become the first FDA-approved oral pill in nearly 30 years for pattern hair loss and a potential best-in-indication treatment option for 50 million men with pattern hair loss.
