Positive Phase 2a results in androgenetic alopecia support progression into Phase 3 trials in 2026
Pelage Pharmaceuticals, a clinical-stage regenerative medicine biotechnology company, announced the close of a $120 million Series B financing co-led by ARCH Venture Partners and GV, with participation from existing investors including Main Street Advisors, Visionary Ventures, and YK Bioventures. The financing will support the continued advancement of Pelage’s lead program, PP405, a topical small molecule designed to reactivate dormant hair follicle stem cells, offering a potential first-in-class approach for both men and women experiencing hair loss.
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“At Pelage, our goal is to deliver a clinically-tested treatment to combat hair loss, grounded in innovative science. Despite the growing need for treatments for hair loss, which affects more than 80% of men and 40% of women throughout their lifetimes, innovation has been lacking, and a new FDA-approved option has not become available for decades,” said Daniel Gil, Ph.D., Chief Executive Officer of Pelage Pharmaceuticals. “Our approach is based on the groundbreaking discovery that hair follicle stem cells have a unique metabolic switch. Supported by over ten years of bench research on the mechanism and associated biological pathways, we have designed a first-in-class investigational treatment that reactivates these hair follicle stem cells to regrow hair. This new funding from leading investors reinforces not only the need in the space, but the quality of our scientific approach and clinical results to date, which are enabling us to enter Phase 3 trials for lead program PP405 in 2026.”
“Pelage is a pioneer in the regenerative medicine space, with a scientifically rigorous approach to address hair loss that sets them apart from currently available treatments. This could fulfill an urgent need, as we see a growing portion of the population experiencing hair loss, including women, who only have one FDA-approved option,” said Cathy Friedman, Executive Venture Partner at GV. “We at GV are thrilled to continue working with Pelage, and I look forward to partnering with the board and leadership team to support this new potential treatment option.”
“At ARCH, we are excited by disruptive companies pioneering new approaches to improve public health, and we are proud to join this investor syndicate in support of a first-in-class treatment for hair loss,” said Richard Heyman, Ph.D., Venture Partner at ARCH. “Pelage’s leadership team, with deep expertise in dermatology and regenerative biology, is well-positioned to bring a new treatment that is accessible for all to a space that is lacking in treatment options that promote new hair growth.”
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Advancing a first-in-class therapy targeting the root cause of hair loss
PP405 is a novel, non-invasive, topical small molecule designed to reactivate dormant hair follicle stem cells and restart hair growth. In July 2025, the company reported interim results from a randomized, placebo-controlled Phase 2a trial evaluating the safety of PP405 in participants with androgenetic alopecia. The trial enrolled 78 men and women, representing a diverse range of skin phototypes and hair textures, who received topical PP405 or placebo once daily for four weeks; participants were observed for eight weeks following dose completion to track safety and secondary pharmacokinetic endpoints. Preliminary results showed that PP405 met the primary safety endpoint and was well tolerated with no systemic absorption of PP405 detected in the blood and no systemic adverse events. While the trial was designed to assess the safety of PP405, four weeks of dosing demonstrated early differentiation of PP405 from currently available treatments. Notably, at Week 8, four weeks after completion of dosing, 31% of men with a higher degree of hair loss treated with PP405 experienced a greater than 20% increase in hair density compared to 0% in the placebo group. Additionally, PP405 demonstrated an ability to induce new hair growth from follicles where no hair was previously present, offering early validation of its regenerative potential.
Following completion of the randomized controlled phase of the study, participants in the placebo group were eligible to enroll in a three-month open-label extension to assess long-term safety, which is now complete. The company plans to share a full dataset from the trial at a future medical meeting in 2026.
Based on the strong safety profile and initial efficacy observations from this trial, Pelage plans to initiate a Phase 3 trial evaluating the safety and efficacy of PP405 in androgenetic alopecia in 2026.
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Source – businesswire
