Treating pattern hair loss: how close are we? By Roohi Mariam Peter 9 minutesmins May 20, 2026 9 minutesmins Share WhatsApp Twitter Linkedin Email Photo credits: Teslariu Mihai (Unsplash) Newsletter Signup - Under Article / In Page"*" indicates required fieldsLinkedInThis field is for validation purposes and should be left unchanged.Subscribe to our newsletter to get the latest biotech news!By clicking this I agree to receive Labiotech's newsletter and understand that my personal data will be processed according to the Privacy Policy.*Company name*Job title*Business email* Androgenetic alopecia, more commonly known as pattern hair loss, is the most common form of hereditary hair loss. Driven by genetics and hormones, the condition results in finer and shorter hairs and eventually no hair growth in certain areas. For nearly thirty years, there have been no approved drugs by American regulators for pattern hair loss, but soon, this could change, as therapies edge towards approval. Table of contentsVeraDermics’ VDPHL01 hits goals in phase 2/3 trial Connecticut-based VeraDermics’ VDPHL01 is bound to be the next hair loss medicine greenlit by the U.S. Food and Drug Administration (FDA), having seen success in a major clinical trial. You may have heard of the topical foam Rogaine; it was approved by the FDA in 1988 for male pattern baldness, and then for women in 1991. in the late 1990s, it was made available over the counter and around 70% of people who have taken the topical treatment have experienced thicker hair growth and even new regrowth. VeraDermics’ VDPHL01 and Rogaine have the same active ingredient, minoxidil. As a potassium channel opener, it hyperpolarizes the cell membranes in vascular smooth muscle cells. This causes the muscles to relax, leading to the widening of blood vessels. Simply put, minoxidil relaxes the blood vessels, giving way for oxygen and nutrients to enter and nourish hair follicles. This helps ‘wake up’ dormant hair follicles and prolong their growth phase, allowing hair to grow thicker and longer. The difference between Rogaine and VDPHL01, however, is that while Rogaine is a topical foam, VDPHL01 is an extended-release pill, and it was found to be more effective than the scalp treatment. A phase 2/3 trial revealed that VDPHL01 met all primary and key secondary endpoints. The study enrolled 519 men who were either given VDPHL01 or placebo. All the patients in the drug cohort had “robust” increases in hair count, with those on VDPHL01 achieving superior hair growth and a more consistent response. One of the primary endpoints was the non-vellus Target Area Hair Count (TAHC), a metric to determine how much hair has grown to measure the efficacy of hair loss treatments. There was an average increase non-vellus hair count of 30.3 hairs/cm² in patients who received the medicine once every day and a 33 hairs/cm² count in those who took it twice a day. This is a stark improvement from those who were on placebo, who experienced a 7.3 hairs/cm² uptick from baseline after six months. Suggested Articles Could we see a new dawn for hair loss treatments? Can Treg cell therapy really target autoimmunity? Eight rare autoimmune diseases biotechs are fighting to treat JAK inhibitors: Are they a good option for treating inflammatory diseases and cancer? Six immunology biotech companies revolutionizing immune treatments in 2024 Moreover, 79.3% of patients who took the once-daily dose and 86% of patients in the twice-daily dose group reported improvement in hair coverage compared to 35.6% of the people who were on placebo. Maryanne Makredes Senna, dermatologist at Beth Israel Lahey Health and member of Veradermics’ scientific advisory board, thinks that VDPHL01 has the potential to change how physicians and patients approach pattern hair loss for men for the better. Senna said: “I believe that an oral therapy that has improved hair loss in the eyes of nearly 80% of patients and investigators, was generally well tolerated in trials and sits in a class that dermatologists are already comfortable prescribing, has the potential to transform the treatment landscape for male pattern hair loss.” A phase 2 trial is also ongoing to test its efficacy in women with pattern hair loss. Minoxidil in the form of Rogaine has, on occasion, worsened heart problems and caused chest pain in patient. This happens when it is picked up by blood vessels when it absorbed by the scalp. VDPHL01 is less likely to trigger cardiac issues as it is an extended-release formulation. This means that minoxidil enters the blood stream slowly and steadily over a prolonged period. So, the risk of sudden heart rate spikes linked to heart palpitations and fluid retention is minimized. “With a formulation designed to deliver more consistent exposure and avoid peak concentrations associated with dose limiting cardiac side effects, we believe VDPHL01 has a potentially differentiated, generally well tolerated clinical profile with rapid, consistent, and robust hair growth,” said Reid Waldman, chief executive officer (CEO) of Veradermics. “We are optimistic that these results represent a defining milestone for the hair loss community, our company and investors as we advance this foundational, non-hormonal treatment approach to the clinic for the millions of people with pattern hair loss.” Pattern hair loss treatment: VDPHL01 and Pelage Pharma’s PP405 ‘waken’ inactive hair follicles VDPHL01 could become the first non-hormonal oral medicine for pattern hair loss. Aside from topical minoxidil, the only other FDA-cleared drug for pattern hair loss is the hormone blocker finasteride, known by its brand name Propecia, and only approved for use in males. It blocks the enzyme that converts testosterone into dihydrotestosterone, the hormone responsible for male pattern baldness. Hindering the production of dihydrotestosterone, however, does come with side effects, including adverse sexual side effects, such as erectile dysfunction and low libido, and rarer ones like mood changes, anxiety, and depression. Plus, some who take Propecia seek alternatives because there isn’t enough regrowth. That’s why non-hormonal medicines are being sought after. Besides VDPHL01, Pelage Pharma’s non-hormonal topical gel PP405 has had positive outcomes in the clinic and will hit phase 3 trials later this year. Like with VDPHL01, PP405 is intended to ‘wake up’ dormant hair follicles, but unlike VDPHL01, this new class of drugs targets cellular metabolism. The mitochondrial pyruvate carrier (MPC) prevents stem cell activity, so PP405 is designed to inhibit the MPC, upregulating a metabolic pathway that boosts the production of stem cells. A phase 2a trial evaluating PP405 met its primary and secondary endpoints, where 31% of those people treated with the drug exhibited a greater than 20% increase in hair density, compared to none of the patients in the placebo group four weeks after treatment was completed last year. To add to that, the gel induced new hair growth from follicles where no hair was previously present, exhibiting that it has regenerative potential, according to the California-based startup. The treatment’s impact on follicular regeneration was presented at the American Academy of Dermatology (AAD) annual meeting in Colorado in March. Meanwhile, Massachusetts-based Eirion Therapeutics’ small molecule ET-02 is also designed to spur stem cell growth in hair follicles. As these cells sometimes become inactivated, ET-02 is intended to switch them back on, addressing a fundamental cause of pattern hair loss. A phase 1 clinical study showed that taking 5% of the topical cream led to a six-fold increase in hair count compared to the placebo group after five weeks, according to results published in early 2025. Hormone blocker clascoterone nears finish line for male pattern hair lossFemale pattern hair loss is thought to affect around 40% of women by the age of 50 and male pattern hair loss affects about 80% of males by the age of 80. There are more drugs approved for men than there are for women, including Propecia and off-label dutasteride. Cosmo Pharmaceuticals is also developing a treatment specifically for male pattern hair loss; the hormone blocker clascoterone. It is a topical androgen receptor blocker that prevents DHT from binding to the hair follicles directly on the scalp. Already approved for treating acne and dubbed Winlevi – containing 1% of clascoterone – it reaped positive phase 3 results. Announced last month, the study found that men who stayed on 5% clascoterone for 12 months saw a statistically significant 2.39-times improvement in hair count compared to those who stopped the treatment after six months. “These 12-month phase 3 results mark a defining moment for clascoterone and for the treatment of male hair loss. We are now seeing the combination that matters most: positive long-term safety, statistically significant continued hair growth through one year, and clear evidence that ongoing treatment drives sustained benefit. In a disease that has seen limited innovation for decades, clascoterone has the potential to emerge as a major new therapeutic option and a highly valuable growth platform for Cosmo. We are moving with urgency toward regulatory submissions and commercialization discussions,” said Giovanni Di Napoli, CEO of Cosmo, in a press release. Pattern hair loss is not to be confused with alopecia areata, an autoimmune disease where the immune system attacks the hair follicles, resulting in patches of hair loss on the body. For this, JAK inhibitors have been authorized by the FDA, as they block inflammatory signals in the immune system. Pharma giant AbbVie’s own JAK inhibitor Rinvoq is closing in on approval, and currently, London-based Soterios Pharma’s small molecule STS-01, which is a non-steroidal topical cream, and Nektar’s biologic rezpegaldesleukin that targets regulatory T cells are in the clinic to treat the autoimmune condition as well. These therapies hold promise in addressing hair loss, and the confidence in them has been indicated by recent funding rounds. VeraDermics’ went public with $256 million in February in the run up to announcing its clinical progress, Pelage Pharma locked in $120 million in a series B round late last year, and Nektar Therapeutics scooped up $325 million in a public offering last month. With VDPHL01 poised to be the first new drug in three decades to hit the market for pattern hair loss, it is currently recruiting people for its female pattern hair loss trial and topline results are anticipated for its second phase 3 male pattern hair loss trial later this year. As the various therapies in the clinic all work differently, we will have to wait and see which ones come out of the clinic strongest. This article is reserved for subscribers Subscribe for free to continue reading.Enter your details to log in or subscribe. 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