A new oral drug stands to become the first prescription pill specifically designed to regrow hair in both women and men. If approved following current Phase 3 trials, it would be the first new treatment for pattern hair loss in nearly 30 years – and the first oral therapy for women approved by the US Food and Drug Administration (FDA).
The drug, currently known as VDPHL01, is a re-engineered extended-release version of oral minoxidil. Minoxidil (sold under brand names like Loniten) was originally created to treat high blood pressure, and was later found to promote hair growth as a side effect. But while current oral minoxidil delivers a brief spike of the drug to the bloodstream, lasting only a couple of hours – offering what we believe to be a few hours of stimulating hair follicle growth – it also comes with a high risk of negative cardiovascular issues like pericardial effusion, where too much fluid builds up in the sac around the heart.
VDPHL01 extends this window of activity with sustained release of the active drug while avoiding those spikes, minimizing the heart and stroke risks. It also does away with the mess of topical minoxidil (Rogaine), which delivers the drug locally and is absorbed into the scalp.
The drug, from Connecticut-based biotech company Veradermic, is currently in multiple Phase 3 trials across the US. It’s believed that if VDPHL01 continues on its promising path in this stage, the makers will seek FDA approval early next year.
According to Veradermics, in one study, 21 male participants had an average boost of 37.5 hairs per square centimeter in the target area after two months, and 47.3 hairs after four.
In this Phase 2 study, nearly 91% participants reported visible improvement, and 95% said they were more satisfied with their hair coverage. Importantly, the treatment so far appears well tolerated, with no serious or cardiac side effects reported.
“As a clinician and researcher, I have not seen an investigational therapy for hair loss indicate the potential for quick results like VDPHL01 based on two- and four-month data,” stated Dr Jerry Shapiro, M.D., Professor of Dermatology at New York University School of Medicine and Veradermics advisor. “I believe VDPHL01 could become the new benchmark for treating pattern hair loss in both women and men.”
Pattern hair loss affects around 80 million Americans, yet treatment options remain very limited. If VDPHL01 lives up to the early results, it could become the first new prescription hair-growth therapy in decades, for both men and women.
Source: Veradermics
