October 29, 2026 | Indero, a niche global contract research organization (CRO), is supporting Pelage Pharmaceuticals, a clinical-stage regenerative medicine biotechnology company, on its lead clinical program. This includes the Phase 2/3 AWAKEN clinical trial of PP405, a novel, non-invasive topical small molecule designed to reactivate dormant hair follicle stem cells, which began dosing male patients living with androgenetic alopecia (AGA), or pattern hair loss, this month and is actively enrolling.
Pelage and Indero began this partnership in early 2024 to support the execution of Pelage’s Phase 2a trial for men and women with AGA. Last year, Pelage reported topline results from the study, which met the primary endpoint and showed PP405 was well tolerated in men and women with no systemic absorption. While dosing was limited to four weeks, results in men with a higher degree of hair loss showed a rapid and significant clinical response by week eight, four weeks after completion of treatment.
Based on these results, Pelage is bringing PP405 into late-stage development, supported by Indero’s experience with dermatology clinical research, end-to-end management of global studies and early phase research. AWAKEN is a randomized, double-blind, placebo-controlled, 12-month study of adult men with AGA, expected to enroll approximately 600 participants in the United States and Canada. Later this year, the company plans to initiate a Phase 2 trial extending PP405’s non-hormonal, topical approach to women with AGA. “Women have even fewer treatment options for hair loss today than men,” said Christina Weng, M.D., Chief Medical Officer at Pelage. “PP405 has the potential to offer a more direct, gender-agnostic approach to restoring hair growth.”
Jeff Smith, Chief Executive Officer at Indero, added: “Pelage is advancing a truly innovative approach to hair regeneration, and we are proud to be their partner. Throughout the past three years, our teams have collaborated closely, combining scientific expertise, operational excellence, and a commitment to advancing innovation. The strength of our partnership is rooted in a shared belief that bold science, supported by rigorous execution, can help accelerate the development of the next generation of therapies for hair loss.”
For more information, contact:
Heather Angus-Lee
Communications Specialist
Indero
[email protected]
1-866-575-3111, ext. 170
Amanda Lazaro
Managing Director
1AB Media
[email protected]
About Indero
Indero is a niche CRO with a dual focus in dermatology and rheumatology, managing global clinical trials for more than 25 years. Indero provides full services from study design through site selection and management, patient recruitment, project management, biostatistics and data management, medical writing, quality assurance, regulatory and clinical development, pharmacovigilance, and medical monitoring for dermatology and rheumatology. For more information, visit inderocro.com.
About Pelage
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, visit pelagepharma.com.
