Pelage Pharmaceuticals Announces First Patient Dosed in Phase 2/3 AWAKEN Trial of PP405 for Androgenetic Alopecia, the Most Common Form of Hair Loss

AWAKEN will evaluate the efficacy and long-term safety of PP405, a first-in-class topical therapy designed to reactivate dormant hair follicle stem cells and restore hair growth, in men with androgenetic alopecia (AGA)

Builds on positive Phase 2a results demonstrating new hair growth from previously dormant follicles and strong safety profile

Phase 2 trial extending PP405's non-hormonal, topical approach to women with AGA to initiate by end of 2026

LOS ANGELES--(BUSINESS WIRE)--Pelage Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class regenerative treatments for hair loss, today announced that the first patient has been dosed in the Phase 2/3 AWAKEN clinical trial evaluating PP405 in adult men with androgenetic alopecia (AGA), also known as pattern hair loss. The trial initiated on schedule following a positive end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA).

“Dosing the first patient in the AWAKEN trial marks an important milestone for Pelage as we advance PP405 into late-stage development and move closer to our goal of delivering a clinically-validated treatment that addresses the underlying biology of hair loss,” said Daniel Gil, Ph.D., Chief Executive Officer of Pelage. “Our Phase 2a results provided early clinical validation of PP405’s regenerative potential, demonstrating new hair growth from follicles where no hair was previously present and laying the foundation for this next stage of our clinical program.”

AWAKEN is the first clinical trial in the company’s late-stage clinical development program for PP405, designed to evaluate the efficacy and long-term safety of a novel approach to hair loss. The company is also on track to initiate a Phase 2 trial of PP405 in women with AGA by the end of 2026 and is planning for additional trials to address hair loss across both men and women.

“Hair loss is multifactorial, with important differences in the biology of androgenetic alopecia in men and women that are still not fully understood,” said Christina Weng, M.D., Chief Medical Officer of Pelage. “By directly targeting hair follicle stem cells rather than a specific hormonal or upstream pathway, PP405 has the potential to offer a more direct, gender-agnostic approach to restoring hair growth. This could be particularly meaningful for women, who have fewer treatment options today, while reinforcing the potential for PP405 to establish a new treatment approach for all people experiencing hair loss.”

The AWAKEN trial builds on the previous Phase 2a trial, which evaluated PP405 in both men and women. 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. Early signs of increased hair density were observed compared to placebo, and PP405 demonstrated an ability to induce new hair growth from follicles where no hair was previously present, offering early validation of its regenerative potential.

About the Phase 2/3 AWAKEN Trial

The Phase 2/3 AWAKEN clinical trial is a randomized, double-blind, placebo-controlled, 12-month study designed to evaluate the efficacy and long-term safety of PP405 in male patients with Norwood-Hamilton Type IV or V AGA. The trial is expected to enroll approximately 600 adult men in the United States and Canada. The trial will assess a number of quantitative and qualitative endpoints, including the change in non-vellus Target Area Hair Count (nvTAHC), the patient-reported outcome (PRO), and measures of follicular reactivation. For more information about the AWAKEN trial, visit https://clinicaltrials.gov/ (NCT07819435).

About PP405

PP405 is a novel, non-invasive topical small molecule designed to reactivate dormant hair follicle stem cells and restart hair growth by targeting a unique metabolic switch that regulates hair follicle stem cell activation. Supported by more than 10 years of bench research into the mechanism and associated biological pathways, PP405 is being developed as a potential first-in-class treatment for androgenetic alopecia in men and women. In a Phase 2a clinical trial, PP405 demonstrated a strong safety profile with no systemic absorption, as well as early clinical validation of its regenerative potential.

About Pelage Pharmaceuticals

Pelage Pharmaceuticals is a clinical-stage regenerative medicine biotechnology company developing first-in-class treatments for hair loss. With a focus on stem cell biology and metabolism, Pelage is advancing a novel class of therapies designed to reactivate dormant hair follicle stem cells and restore the body’s natural ability to grow hair. Its lead program, PP405, is currently in clinical trials for androgenetic alopecia. With its rigorous scientific foundation, Pelage is pioneering first-in-class hair-growth solutions for men and women of all hair types experiencing hair loss.

For more information about Pelage, visit https://pelagepharma.com/ and follow us on LinkedIn and X. To learn more about upcoming trials for PP405, sign up for updates at https://www.pelagepp405.com/.