VDPHL01
About
VDPHL01
Designed to be the First Non-Hormonal Oral Therapeutic for Hair Regrowth in Women and Men
VDPHL01, if approved, has the potential to be the first extended-release oral minoxidil designed specifically for women and men with pattern hair loss – the largest aesthetics condition worldwide, with no new prescription therapies in nearly 30 years, and no oral prescription therapies approved by the FDA for women.
Oral minoxidil was not originally designed for hair regrowth. VDPHL01 is.
Minoxidil has shown to be effective in growing hair in both men and women. Various formulations and concentrations of minoxidil are used for pattern hair loss. But the reality is, immediate release oral minoxidil was originally designed for high blood pressure, not hair loss.
Immediate release oral minoxidil reaches peak concentrations within one hour and materially clears within four hours, limiting the time available to stimulate regrowth, and has been shown to be associated with cardiac toxicities.
Topical minoxidil 5% (i.e. Rogaine) delivers only modest efficacy with variable response rates and a burdensome application to the scalp that results in 86% of patients discontinuing within a year.
Veradermics utilized a proprietary extended-release technology to create VDPHL01, an oral tablet designed to extend exposure of minoxidil to hair follicles over time. This release profile has the potential for fast, consistent and more intense hair growth, while avoiding concentration spikes above the drug’s ‘cardiac activity threshold,’ the blood levels at which cardiac effects are first observed.
VDPHL01 is now enrolling men and women in phase 3 clinical trials.
The studies are being conducted at trial sites across the U.S.
Phase 2 and 3 trials for male and females are underway
The open-label, multi-dose Phase 2 trial is evaluating the safety and efficacy of VDPHL01 in men and women with mild to moderate pattern hair loss, with primary endpoints of target area hair count and patient reported outcomes on the treatment’s effectiveness.
Enrollment began first with males, and dosing is currently ongoing in both male and female study participants for Phase 2. In addition, Veradermics has initiated three multicenter, randomized Phase 3 clinical trials of VDPHL01 in males and females with pattern hair loss.
Veradermics recently reported preliminary results following a four-month treatment period from the male Phase 2 trial. Among 21 male participants in the Phase 2 trial who received VDPHL01 8.5 mg twice daily (BID) for four months, participants achieved an average increase in non-vellus hair count (thickened and usually pigmented hairs) of 47.3 hairs/cm2. In addition, in that same four-month period, 90.5% of male patients receiving VDPHL01 reported seeing ‘improved’ or ‘much improved’ hair coverage. Importantly, VDPHL01 has been generally well tolerated, with no serious adverse events reported to date in the study, including no cardiac adverse events.
