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It may be one of the biggest conundrums in the world of hair: Despite hair loss<\/a> being one of the most prevalent aesthetic concerns among both women and men, treatment options\u2014at least those clinically tested with high efficacy rates\u2014have remained extremely limited. Minoxidil, a.k.a. Rogaine, earned FDA approval for topical use in 1991. It’s still widely used\u2014but it can be annoying and inconvenient to apply. Finasteride, a.k.a. Propecia, was FDA-approved as an oral treatment for males only back in 1997. (And it comes with its own risks<\/a>.) Meanwhile, there\u2019s never been an oral treatment approved for female pattern hair loss<\/a>. <\/p>\n However, a new drug may finally change all that. Veradermics<\/a>, a Connecticut-based biopharmaceutical company, is developing a new drug specifically for androgenetic alopecia, or pattern hair loss, in both women and men. <\/p>\n Called VDPHL01 (at least for now), the treatment is an extended-release oral minoxidil and has been in development since late 2021. \u201cWe’re actively in three phase-three studies, two in males, and then the first-ever phase-three study for female pattern hair loss,\u201d Veradermics CEO and dermatologist Reid Waldman explains exclusively to Harper\u2019s Bazaar. So far, the results are extremely promising, which shouldn\u2019t come as a surprise, considering oral minoxidil is already on the market<\/a> and being used to treat hair loss. Officially, however, it\u2019s a blood pressure medication; it\u2019s not currently FDA-approved for hair loss. \u201cIt\u2019s still considered an off-label use, which makes some patients and even providers hesitant,\u201d Dendy Engelman<\/a>, a board-certified dermatologist in New York, previously told Bazaar. <\/p>\n What sets VDPHL01 apart from the existing treatments is that it\u2019s an extended-release oral minoxidil tablet, which minimizes potential cardiac risk. \u201cInitially, [minoxidil] was actually approved as a blood pressure medication, and as an oral treatment, it was never meant to be a hair loss drug,\u201d explains Waldman. The reason that matters, he explains, is how it interacts with the body when it\u2019s taken. \u201cIt comes into the body very quickly, which is really great if you want to rapidly control someone’s blood pressure. It’s not so great for driving hair growth with reduced cardiac risk.\u201d <\/p>\n The other benefit of the extended-release formulation is that it optimizes the hair-growth benefits. \u201cThe idea here is that we want to give consistent exposures at the hair follicle to the minoxidil with a slow release, via a proprietary hydrogel technology,\u201d explains Waldman. With the existing oral treatment, he explains, \u201cThe majority of it is out of your body within two hours, and it falls below a critical hair threshold within four hours. Whereas we want to try to increase the amount that’s available over 12 to 24 hours to try and give your hair more stimulation over time.\u201d<\/p>\n The company plans to submit for FDA approval if the results of the trials continue as promised. \u201cWe anticipate that in the first half of 2026, we will have the initial phase-three male data, and all of the male data in the 2026 timeframe,\u201d explains Waldman. \u201cAnd then on the back end of that, in some time, the drug would file for an approval should the data be positive.\u201d<\/p>\n That data, he explains, is both quantitative and qualitative\u2014because those looking to reverse hair loss shouldn\u2019t have to ask their hairstylist or friends if they notice a difference; the results should be indisputable. \u201cWe believe that that’s what we’re seeing in phase two, with over 90 percent of people having a double-digit increase in the hair count, which is an objective metric,\u201d Waldman says. (According to Veradermics, 21 male participants showed an average increase of 37.5 hairs per square centimeter in the target area after two months, and 47.3 hairs after four months.) Beyond that, they could really see the difference. \u201cAt month two, we saw a visibly noticeable regrowth.\u201d <\/p>\n Related Story<\/p>\n In the world of hair growth, two months is the equivalent of the blink of an eye (or a toss of the hair). \u201cIn my clinical practice, I always told people it’s going to be six months until you see regrowth, and it’s going to be another six months until we really know where you end up,\u201d says Waldman. \u201cSo it was very encouraging to us to see hair growth so quickly.\u201d<\/p>\n Crucially, the trials include people with all hair and skin types. \u201cWe have strong representation across different hair patterns, hair textures, and ethnic groups,\u201d assures Waldman, who notes that those with tight curl patterns sometimes show a different response or presentation of hair loss. <\/p>\n As for side effects, he is quick to note what they’re not seeing: the hormonal side effects that can present with finasteride (which, again, is only approved for use in males). The extended-release formula seems to be doing its intended job, too. \u201cOverall, we saw no serious treatment-related cardiac adverse events in the phase-two study,\u201d he says.<\/p>\n 85 percent of men and 50 percent of women will develop hair loss in their lifetime<\/p><\/blockquote>\n<\/blockquote>\n
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