New Hair-Growth Drug Shows Promising Results in Clinical Trial
A new version of a popular hair-growth drug has shown remarkable results in a recent clinical trial, with participants experiencing significant regrowth of hair. The study, conducted by Connecticut-based Veradermics, involved more than 500 men and demonstrated the effectiveness of an extended-release oral form of Minoxidil.
Veradermics developed a turbocharged-like formulation of Minoxidil, which delivers twice the amount of the drug over 12 hours compared to the standard version. This experimental drug, called VDPHL01, was tested as an oral pill for pattern hair loss.
In the study, men 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. In contrast, those in the placebo group saw just seven more hairs per square centimeter over the same period. Between 79 and 86 percent of men who took the experimental medication reported visible improvements in their hair, compared to only 35 percent in the placebo group.
Researchers noted that the results were visible within just two months of starting the treatment. Veradermics believes that VDPHL01 could become the first FDA-approved oral pill for hair loss in nearly 30 years.
Dr Michael Gold, a dermatologist and investigator in the trial, explained that current treatments for hair loss often involve drugs originally developed for other conditions. He emphasized that VDPHL01 is the first oral minoxidil formulation specifically designed for pattern hair loss and has generated positive Phase 3 results of efficacy and safety.
Hair loss is a widespread 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 $3.5 billion every year on supplements, surgeries, and drugs that doctors say can slow hair loss. Current treatments include hair transplants, finasteride (an oral drug used to prevent further hair loss), and minoxidil (which can be taken orally or topically to promote 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. The experimental drug contains 8.5 mg of minoxidil.
The study, which was a Phase 2/3 trial of the experimental treatment, compared VDPHL01 against a placebo. Some studies suggest that the drug may be more powerful than existing minoxidil formulations. 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.
However, others argue that 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 heartbeats or high blood pressure.
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 stated that their drug was generally well tolerated, with 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 experienced 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 increases the nutrient and oxygen supply to follicles—helping them trigger hair regrowth.
Phase 3 trials and FDA approval will be needed before VDPHL01 can reach the market, which is likely still some time away. The company did not disclose how much the 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.”
She added, “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 stated that 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.
