VDPHL01
About
VDPHL01
Designed to be the First Non-Hormonal Oral Therapeutic for Hair Regrowth in Women and Men
VDPHL01, if approved, is poised to be the first and only 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 is the only agent that 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, oral minoxidil was originally designed for high blood pressure, not hair loss. With immediate release oral minoxidil, the drug level spikes right after its taken and majority of the drug leaves the body after approximately two hours, limiting the time available to stimulate regrowth, and has been shown to be associated with cardiac toxicities.
Topical minoxidil 5% (i.e. Rogaine) has also shown limited efficacy and nearly 90% of patients discontinue use primarily due to its messy, cumbersome application.
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.
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, and 95.0% expressed increased satisfaction in their 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.
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