Veradermics has released topline results from a phase 2 study of its lead drug VDPHL01, an extended-release oral formulation of minoxidil, in women with pattern hair loss.
The New Haven, Connecticut-based biotech’s data covers women with mild-to-moderate female pattern hair loss, a market analysts describe as significantly underserved and commercially attractive.
Minoxidil was first approved as the topical treatment Rogaine in 1988, and Veradermics’ formulation is designed to improve on that legacy through an oral, extended-release approach.
Veradermics suggested in a July 15 release that VDPHL01, if approved by the FDA, holds the potential to become the first oral treatment for female pattern hair loss with a formal U.S. approval.
Investors responded positively to the midstage readout, helping carry Veradermics’ stock price up by more than 14% as of late Wednesday morning.
Analysts at Citi wrote to clients that the results “strengthen our view that VDPHL01 could address a sizable, underserved female pattern hair loss market where topical adherence is poor, oral minoxidil is widely favored in practice, and no FDA-approved oral option exists.”
The Citi team noted that because the study was small and open label, “randomized validation remains necessary,” but said the data raised confidence ahead of a phase 2/3 readout in the same population expected in the first half of 2027.
The phase 2 Study 207 recruited 28 participants, with approximately 88.9% of once-daily patients and 90.0% of twice-daily patients reporting improved or much improved outcomes at Month 6.
Robust hair growth was observed with a mean increase in non-vellus target area hair count of 22.7 hairs per square centimetre and 23.3 hairs per square centimetre at Month 6, in once and twice daily dosing regimens respectively.
No treatment-related serious adverse events and no adverse events of cardiac origin were observed, with Veradermics describing the safety profile as consistent with prior VDPHL01 trials.
The company’s proprietary gel matrix is designed to deliver a steady, long-lasting release of minoxidil, avoiding the high peak concentrations associated with immediate-release oral versions of the drug.
In April, Veradermics announced topline results from Study 302, a registration-directed phase 2/3 trial in male-pattern hair loss, while enrollment in Study 304, a second phase 3 male trial, was completed in February with results anticipated in the second half of 2026.
If approved, VDPHL01 would be the only FDA-approved oral non-hormonal treatment for pattern hair loss in both male and female patients, with patent protection extending to at least 2043.