New Experimental Pill Shows Promise for Pattern Baldness
An extended-release version of minoxidil could be the first new oral treatment for hair loss in nearly three decades.
Men experiencing pattern baldness may soon have a new oral treatment option, with an experimental pill showing promising results in a Phase 3 clinical trial. The drug, an extended-release version of minoxidil, the active ingredient in Rogaine, successfully regrew hair in men over a six-month period and could be the first new pill for pattern baldness to reach the market in nearly 30 years.
The trial, conducted by biopharmaceutical company Veradermics, involved 536 men with mild to moderate hair loss. Participants were administered a once-daily 8.5 milligram dose of the experimental pill, VDPHL01, a twice-daily dose, or a placebo. Both dosages of VDPHL01 demonstrated superior performance compared to the placebo.
Men taking the once-daily dose experienced an average increase of 28.6 hairs per square centimeter of scalp, while those on the twice-daily regimen saw an average gain of 36.4 hairs per square centimeter. In comparison, patients who received a placebo gained an average of 6.6 hairs per square centimeter.
While oral minoxidil has been used for hair loss previously, immediate-release formulations could lead to more side effects for some users, including potential cardiac risks such as rapid heart rate, fluid accumulation around the heart, and chest pain. Veradermics' extended-release formulation aims to mitigate these issues by potentially lowering peak drug concentration in the body. The company reported that the drug was generally well-tolerated in the study, with no serious treatment-related adverse events or cardiac issues recorded. However, participants did report increased instances of swelling and unwanted hair growth compared to the placebo group.
VDPHL01 contains nearly double the maximum recommended daily dose of 5 milligrams of minoxidil found in conventional treatments. Minoxidil functions by widening blood vessels, which enhances the delivery of nutrients, oxygen, and blood flow to hair follicles. This process is believed to extend the active growth phase of existing hair and stimulate dormant follicles to become active.
The company is also recruiting women for a Phase 3 trial for female pattern hair loss. Veradermics hopes the pill will be the first FDA-approved, non-hormonal oral treatment for pattern hair loss. If studies continue to yield positive results and regulatory approval is granted, the drug could be available within the next two to three years, according to Dr. Reid Waldman, CEO of Veradermics.