Pelage Pharmaceuticals Doses First Patient in Phase 2/3 AWAKEN Trial for PP405
Los Angeles-based biotech company Pelage Pharmaceuticals has dosed the first participant in its Phase 2/3 AWAKEN human clinical trial evaluating its topical candidate, PP405, across clinic sites in the United States.
Key Study Facts
- Study Size & Timeline: Listed on ClinicalTrials.gov under ID NCT07819435, the study plans to enroll about 600 adult men for a 24-week main study period, with safety follow-ups continuing through Week 52.
- University Roots: Pelage Pharmaceuticals was started by researchers from the University of California, Los Angeles (UCLA) Broad Stem Cell Research Center.
- Next Steps: Alongside the male trial kickoff, the company announced plans to launch a separate Phase 2 study for female participants before the end of 2026.
Industry Context
The AWAKEN Phase 2/3 trial follows Pelage Pharmaceuticals' $120 million Series B investment co-led by GV (Google Ventures) and ARCH Venture Partners. Together with Veradermics' $472 million funding and Amplifica's $26 million Series B round, total tracked 2025–2026 investment in late-stage hair research companies has reached $618 million. Both Pelage (UCLA) and Amplifica (UC Irvine) were founded by University of California researchers and are now running multi-center human trials.