THE THIRD-PARTY HUMAN RECORD
PP405 Hair-Loss Clinical Research
Every study discussed on this page is a third-party PP405 study conducted and reported by Pelage Pharmaceuticals. These are not Pelogen™ clinical trials: no Pelogen™ formulation has been studied in humans, and no Pelogen™ clinical trial has been performed or completed.
The registered study: NCT06393452
The single registered human study of PP405 in hair loss is ClinicalTrials.gov record NCT06393452: “A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia”, sponsored by Pelage Pharmaceuticals. The registry records a randomized, double-blind, vehicle-controlled design in 78 enrolled adults (actual), started 2024-06-05 and listed as completed.[4]
A registry entry is the authoritative record of a trial’s design and status. It is not a results publication: the findings attached to this trial exist, at the last evidence search, as company communications rather than peer-reviewed papers.
- Registry number
- NCT06393452 (ClinicalTrials.gov)
- Sponsor
- Pelage Pharmaceuticals, Inc.
- Design
- Randomized, double-blind, vehicle-controlled, Phase 2a
- Population
- 78 adults with androgenetic alopecia (actual enrolment)
- Status
- Completed (registry record)
- Intervention
- Topical PP405 versus topical vehicle gel
What the developer has reported
In its 2025-06-17 announcement, Pelage Pharmaceuticals states that the trial met its primary tolerability endpoint and its secondary pharmacokinetic endpoint, with no detectable systemic absorption of PP405 in blood. The company also reports an exploratory efficacy signal: at week 8, 31% of treated men with a higher degree of hair loss showed a greater than 20% increase in hair density, versus 0% on vehicle.[5]
In its 2025-10-15 announcement of a $120M Series B financing, the company restated those findings and stated its intention to initiate Phase 3 trials in 2026, with a full Phase 2a dataset to be presented at a future medical meeting.[6]
Limitations, stated plainly
- Company-reported data: the findings come from sponsor announcements, not peer-reviewed publications.
- Exploratory subgroup: the density figure concerns a subset of men with a higher degree of hair loss at an early, week-8 timepoint.
- Early phase: Phase 2a is designed for tolerability and pharmacokinetics, not definitive efficacy.
- No independent replication: no third-party academic group has published a replication of the human findings.
- Durability unknown: nothing is established about long-term maintenance of any observed effect.
- Not transferable across formulations: results belong to the developer’s trial vehicle and say nothing about any other formulation — including Pelogen™.
What happens next in the third-party programme
The developer states that Phase 3 trials — the larger controlled studies designed to test efficacy properly — are planned from 2026, funded by the Series B financing. Until those trials report in peer-reviewed form, PP405 remains an investigational compound with early, company-reported human data. This site will update its research watch as verifiable records appear.[6]
And Pelogen™?
Pelogen™ has no clinical record because none exists: it is a laboratory formulation-research platform. For the platform’s own status see the research status page; for the wider science, PP405 hair regrowth research; for sources, the scientific source library; for the platform overview, the Pelogen™ homepage and Panacea Bio Chem ↗.