Two weeks ago, Biohack reported that Pelage Pharmaceuticals had treated the first man in AWAKEN, a roughly 600-man trial of its scalp gel PP405 (our earlier article). The new step: the company has now registered a separate trial in women. The record, posted on October 30, 2026, describes a study of the gel in adult women with pattern hair loss, the common, inherited kind doctors call androgenetic alopecia1.
The trial has not started yet. Its status is listed as “not yet recruiting,” with a planned start in November 20261. Pelage had said in October that it was on track to begin a trial in women by the end of 20262.
What the new trial will test
The study plans to enroll about 200 adult women1. It is described as a Phase 2 trial, a mid-stage test meant to check whether a drug helps and how safe it is before the largest studies. The women will be split at random between PP405 0.05% gel and a “vehicle” gel, which is the same gel without the active drug, acting as a dummy treatment1. The study is double-blind, meaning neither the women nor the researchers will know who is getting which gel, and it will run at several sites1.
The main measure is the change in “non-vellus target area hair count” after 24 weeks1. In plain words, researchers will count the thicker, fully formed hairs (not the fine, wispy “vellus” hairs) in a marked patch of scalp, then compare how that count changed with the real gel versus the dummy gel. The registry lists September 2027 as the date when data for this main measure should be complete1.
The design mirrors the men’s trial in several ways. AWAKEN uses the same 0.05% gel, the same dummy-gel comparison and the same 24-week hair count as its main measure3. The differences are in size and stage. AWAKEN is a combined Phase 2/3 trial, a later-stage study that also tracks long-term safety, and it aims to enroll about 600 men3. Pelage says AWAKEN will last 12 months and take place in the United States and Canada2. The women’s trial is smaller and earlier in the process1.
The evidence so far
PP405 is a small-molecule drug applied to the scalp. Pelage says it is designed to reactivate dormant stem cells in hair follicles by targeting a “metabolic switch” that controls when those cells become active2. The idea is to restart growth in follicles that are still alive but have stopped producing hair. A clinic that summarized the research says the molecule was identified by researchers at UCLA4.
The main human data come from an earlier Phase 2a trial, a small first test of whether a drug shows signs of helping. Pelage says that study included both men and women2. A hair-transplant clinic’s summary describes it as a 78-person trial completed in 20254.
According to Pelage, the gel met the study’s main safety goal, was well tolerated, and was not detected in participants’ blood2. The company also says it saw “early signs of increased hair density” compared with a placebo, and new hair growing from follicles where no hair had been present before2.
Bauman Medical, another hair-loss clinic, wrote that about 31% of participants with more advanced hair loss saw more than a 20% increase in hair density after 8 weeks, compared with none in the placebo group5. That figure comes from a clinic’s account of the company’s announcement, not from a published paper, and Biohack’s earlier article described the small study as lasting 4 weeks. The sources available here do not settle the exact length.
What it does not show yet
The new trial is a plan, not a result. No woman has yet received the gel in this study1.
The earlier results have clear limits. The study was small, its hair-growth findings were described by the company as early signs, and the sources given to Biohack do not include a peer-reviewed paper reporting them2. The sources also do not say how women, as a separate group, responded in that study. That is part of what the new trial is meant to answer.
Pelage’s own chief medical officer, Christina Weng, has pointed to how much is still unknown:
“Hair loss is multifactorial, with important differences in the biology of androgenetic alopecia in men and women that are still not fully understood”
She said this in the company’s October announcement2. The company argues that because PP405 aims at follicle stem cells rather than hormones, it could work in both sexes2. That is a hypothesis the trial is built to test, not a finding.
There is also a biological ceiling. Even supporters note that a drug of this kind is meant for follicles that are dormant, not ones that are gone. One clinic writes that it cannot regrow hair where follicles are dead4.
Who is behind it
Pelage Pharmaceuticals, based in Los Angeles, sponsors both trials13. Its chief executive is Daniel Gil2. The company says PP405 is backed by more than 10 years of lab research into how it works2. It also says the men’s trial began after what it called a positive meeting with the U.S. Food and Drug Administration (FDA) at the end of the Phase 2 stage2. Those are the company’s descriptions.
Two of the sources that summarize PP405’s results are hair-loss clinics, Advanced Hair Restoration and Bauman Medical, which sell other hair-loss treatments, including hair transplants45. Both pages urge readers not to delay existing treatments while waiting for PP40545. Their framing reflects their business, and their numbers trace back to the company’s own reports.
How it fits the field
Pattern hair loss is common in both sexes. In a 2024 interview with the trade publication Clinical Leader, Weng said around half of men and women are affected6. She noted that it tends to look different: in men it mostly affects the hairline at the temples and the crown, while in women the most common sign is a widening part6.
Treatment choices are narrow. Weng said only two drugs are FDA-approved for this kind of hair loss, finasteride (sold as Propecia) and minoxidil (sold as Rogaine), and that no new drug had been approved in the previous two decades6. She added that many women cannot take finasteride because of its hormonal effects and the risk of birth defects6. In October, she said women “have fewer treatment options today”2.
She also said past hair-loss trials have not always included all genders and skin types, partly because older scalp-imaging tools worked best on dark hair against light skin6. Pelage says it arranged imaging that could count hair across hair and skin types in its earlier trial6.
What to watch next
- Recruitment. Whether the women’s trial starts on time in November 2026 and changes its status from “not yet recruiting”1.
- AWAKEN progress. The men’s trial is recruiting, with its main data due by December 20273.
- Results in women. Main data from the women’s trial are scheduled for September 20271. The key question is whether hair counts rise more with the real gel than with the dummy gel.
- More trials. Pelage says it is planning additional trials covering hair loss in both men and women2.
- Peer review. Whether the earlier small study, or either new trial, is published in a scientific journal where outside experts can check the methods and numbers.
