{"id":20652,"date":"2026-09-09T13:00:03","date_gmt":"2026-09-09T10:00:03","guid":{"rendered":"https:\/\/www.advancedhairclinics.gr\/?p=20652"},"modified":"2026-09-09T13:01:10","modified_gmt":"2026-09-09T10:01:10","slug":"new-hair-loss-drugs","status":"publish","type":"post","link":"https:\/\/www.advancedhairclinics.gr\/en\/new-hair-loss-drugs","title":{"rendered":"New pills and treatments for hair loss: what the data actually show"},"content":{"rendered":"\n
\n
\n \n \n \n \n
\n

In recent months, hair loss has suddenly turned up on the financial pages. Shares in companies developing drugs for androgenetic alopecia have soared, and comparisons have started to be drawn with the \u201cwave\u201d of obesity drugs. But the question that matters to anyone actually losing hair is not a stock-market one. It is simple: is there anything genuinely new, when will it be available, and what can one expect from it?<\/p>\n

Below we set out, without exaggeration and without promises, exactly what is in development today, what stage it has reached, and what the published data show.<\/p>\n \n <\/div>\n \n \n <\/div>\n<\/section>\n\n\n

\n
\n
\n

\n Why there is so much talk about this now <\/h2>\n \n

Androgenetic alopecia<\/a> is one of the most common conditions in dermatology. In the United States alone it is estimated to affect around 50 million men and 30 million women. Despite the size of that population, no new drug specifically for the condition has been approved since the late 1990s.<\/p>\n<\/div>\n <\/div>\n \n

\n \"FUE\n <\/figure>\n \n \n \n

The available options remain essentially two: topical minoxidil and finasteride, with low-dose oral minoxidil widely prescribed off label. It is precisely this gap \u2013 a large population, limited options, a market paid for mainly out of the patient\u2019s own pocket \u2013 that attracted investor interest. The science itself, as we will see, is advancing more gradually than the headlines suggest.<\/p>\n<\/div>\n <\/div>\n<\/section>\n\n\n\n

\n
\n \n
\n \n

\n 1. VDPHL01: minoxidil in an extended-release tablet <\/h2>\n <\/div>\n \n \n \n
\n

The most advanced program at the moment is VDPHL01 from Veradermics, an 8.5 mg extended-release minoxidil tablet. The rationale is not a new molecule but a new way of delivering it: gradual release aims at more stable drug exposure, with the goal of improving the tolerability of oral minoxidil.<\/p>\n

In the Phase 2\/3 study (\u201c302\u201d), 519 men with mild to moderate androgenetic alopecia were divided into three groups: once daily, twice daily and placebo. At six months, the increase was about 30 hairs per square centimeter on the once-daily dose and about 33 on the twice-daily dose, versus about 7 on placebo. Improvement in coverage was reported by about 79% and 86% of patients respectively, versus 36% on placebo.<\/p>\n

A second Phase 3 study in men (\u201c304\u201d), with 536 participants and a duration of 52 weeks, has completed enrollment, with results expected during the second half of 2026. A program in women is running in parallel, with positive Phase 2 results in July 2026 and Phase 2\/3 data expected in the first half of 2027. The company is preparing an approval application to the FDA.<\/p>\n \n <\/div>\n \n \n <\/div>\n<\/section>\n\n\n\n

\n
\n \n
\n \n

\n 2. Clascoterone 5%: local androgen blockade at the follicle <\/h2>\n <\/div>\n \n \n \n
\n

Clascoterone 5% solution (Cosmo Pharmaceuticals) follows a different logic. It does not lower dihydrotestosterone throughout the body, as finasteride does; it binds locally to the androgen receptors of the follicle, with minimal systemic absorption. The same molecule is already marketed at a lower concentration for acne.<\/p>\n

The Phase 3 program comprised two identical studies, SCALP 1 and SCALP 2, with 1,465 men at 51 centers in the United States and Europe. Both met their primary endpoint. The relative improvement in hair count in the target area versus the placebo solution was 539% in one study and 168% in the other. These figures sound impressive, but they are relative improvements and not an absolute number of new hairs.<\/p>\n

In April 2026, 12-month data were announced showing that patients who continued treatment maintained and increased the effect, while those who switched to the placebo solution after six months showed a decline in the treatment effect. The safety profile remained comparable to the placebo solution. The company is preparing regulatory submissions in the United States and Europe, targeting a US filing in early 2027.<\/p>\n \n <\/div>\n \n \n <\/div>\n<\/section>\n\n\n\n

\n
\n \n
\n \n

\n 3. PP405: activating \u201cdormant\u201d stem cells <\/h2>\n <\/div>\n \n \n \n
\n

PP405 from Pelage Pharmaceuticals is the most different approach among those in clinical development. It is a topical molecule that inhibits the mitochondrial pyruvate carrier and, through this metabolic shift, appears to activate follicular stem cells that are still present even in areas that look bald.<\/p>\n

In the Phase 2a study with 78 participants, the drug was well tolerated and no systemic absorption was detected. The study gave early signs of biological and clinical activity: in men with more extensive hair loss, 31% of those who received PP405 showed an increase in hair density of more than 20% at week 8, versus 0% on placebo. Dosing lasted only four weeks. The company is moving toward late-stage studies in men and women.<\/p>\n

The wording needs care here: the early data do not prove that new follicles are created. The PP405 approach targets the reactivation of stem cells in follicles that are still present but in an inactive state. No peer-reviewed studies of the molecule have been published to date.<\/p>\n \n <\/div>\n \n \n <\/div>\n<\/section>\n\n\n

\n
\n
\n

\n 4. ABS-201: an injectable antibody designed with artificial intelligence <\/h2>\n \n

ABS-201 from Absci is a monoclonal antibody against the prolactin receptor, designed with artificial intelligence tools. It is at a very early stage: the four single ascending dose (SAD) arms of the Phase 1 study included 32 healthy adults, with no serious adverse events and an estimated half-life of at least 65 days. This finding theoretically supports the possibility of two or three doses over a six-month period, but it is not yet a proven dosing regimen. The study has now moved on to the multiple ascending dose (MAD) arm in participants with androgenetic alopecia. The first proof-of-concept data are expected in the second half of 2026 and the full data in early 2027.<\/p>\n<\/div>\n <\/div>\n \n

\n \"\u0386\u03bd\u03b4\u03c1\u03b1\u03c2\n <\/figure>\n \n \n \n <\/div>\n<\/section>\n\n\n\n
\n
\n \n
\n \n

\n A distinction that is often confused <\/h2>\n <\/div>\n \n \n \n
\n

JAK inhibitors also appear frequently in the news, with impressive regrowth rates. Those drugs are for alopecia areata<\/a>, an autoimmune condition with an entirely different mechanism, and not for androgenetic alopecia. They are two different diseases, with different treatments and a different prognosis.<\/p>\n \n <\/div>\n \n \n <\/div>\n<\/section>\n\n\n

\n
\n
\n

\n How to read the numbers correctly <\/h2>\n \n

All of the data above come from company announcements or conference presentations. A few points help in reading them properly:<\/p>\n