A gel that is meant to wake up “sleeping” hair follicles has moved into its biggest test so far. Pelage Pharmaceuticals, a Los Angeles company, said on October 14 that the first patient had been treated in AWAKEN, a trial of its scalp gel PP405 in men with pattern baldness1. Pattern baldness is known to doctors as androgenetic alopecia, and it is the most common form of hair loss1.
This article covers the start of the trial. No results from it exist yet.
What happened
AWAKEN is described as a Phase 2/3 trial. That is a combined design that joins a mid-stage test with the larger, final-stage testing a drug needs before it can be considered for approval1. The company said the trial started on schedule after what it called a positive end-of-Phase 2 meeting with the US Food and Drug Administration (FDA). At that kind of meeting, a company and the regulator discuss plans for late-stage testing1.
According to the public trial registry, the study is expected to enroll 600 adult men. It lists a start date of September 21, 2026, and it was recruiting when last updated2. The men will be randomly assigned to one of two groups. One group gets a 0.05% PP405 gel. The other gets a “vehicle” gel, which is the same gel base with no drug in it2. Neither the patients nor the study staff will know who gets which (a “double-blind” design)1.
The trial runs for 12 months and takes place in the United States and Canada1. It includes men whose baldness is rated Type IV or V on the Norwood-Hamilton scale. That is a common doctor’s chart of how far male hair loss has progressed, and these two types mean fairly advanced thinning on top1.
What the trial will measure
The main measure in the registry is the change in “non-vellus target area hair count” at week 242. In plain terms, researchers count the thicker hairs in a marked patch of scalp, leaving out the fine, fuzzy ones, and compare the count with the starting point. The company says the trial will also look at what patients themselves report and at measures of whether follicles have “reactivated”1.
The registry gives December 2027 as the expected date for collecting the main results2.
The evidence so far
PP405 has been tested in one earlier controlled study, a Phase 2a trial. That is a small mid-stage test. It enrolled 78 men and women with pattern hair loss across a range of skin and hair types3. Participants put PP405 or a dummy gel on their scalp once a day for 4 weeks and were followed for 12 weeks3.
That study was designed mainly to check safety. Its registered main goals were side effects, skin irritation, vital signs, heart tracings and lab tests4. The company said the gel met its main safety goal and was well tolerated, and that no PP405 was detected in the blood3. Signs of new hair growth were tracked only as “exploratory” measures3.
The company’s later headline hair result came from one subgroup. At week 8, four weeks after treatment ended, 31% of men with more advanced hair loss on PP405 had more than a 20% increase in hair density, compared with none in the placebo group5. Pelage also reported new hair growing from follicles that had previously produced none1. The registry shows that results for that study were first posted on September 22, 20264.
What the evidence does not show yet
An evidence review by Anagen, a telehealth company that sells hair-loss treatments, gives PP405 a grade of D. It says the science behind the gel is strong but the clinical data are very limited6. The review points out that hair density was not a planned main or secondary goal of the earlier study. It also notes that the “31% vs 0%” figure was a subgroup analysis done after the fact, with no statistical test between groups, no average hair-count change reported, and no peer-reviewed publication6.
The review raises other gaps as well. The earlier study treated people for only 4 weeks, while standard hair-loss trials run 6 to 12 months. So it is unknown how much hair might grow with longer use, how long it takes to see an effect, or what happens after someone stops6. It also lists the gel as not approved in any country6.
AWAKEN is the first PP405 trial built to answer these questions. It has a set hair-count goal, a dummy-gel comparison and a year of follow-up21. Until it reports, the claim that the gel regrows hair rests on small, early and unpublished data.
How the gel is supposed to work
Pelage describes PP405 as a small-molecule drug, meaning a chemical compound rather than a biologic like an antibody. It is applied to the skin and is designed to restart resting hair follicle stem cells by targeting what the company calls a “metabolic switch” that controls when those cells activate1. The company says this is backed by more than 10 years of lab research1.
According to the Anagen review, PP405 (also coded JXL-069) blocks a protein that carries a fuel molecule called pyruvate into mitochondria, the cell’s power units. This pushes the cell to make more lactate, and the review says that rise in lactate tips hair stem cells from resting into growing6. The review notes that this idea comes from earlier lab research published in Nature Cell Biology and that it has been tested on human tissue outside the body6. It also describes Pelage as a spinout from the University of California, Los Angeles (UCLA)6.
Pelage’s chief medical officer, Christina Weng, said in the announcement that targeting hair stem cells directly, rather than a hormonal pathway, could give a treatment that works regardless of sex1:
“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.”
That is the company’s hope. It has not yet been tested in a large trial in either men or women. AWAKEN includes only men2. Pelage says it plans to start a separate mid-stage trial in women by the end of 20261.
Who is behind it
Pelage sponsors and pays for the trial2. In October 2025 the company closed a $120 million funding round co-led by ARCH Venture Partners and GV (Google Ventures). Existing investors also took part, including Main Street Advisors, Visionary Ventures and YK Bioventures5. With that round, Cathy Friedman of GV became chair of the board and Richard Heyman of ARCH joined it. The company is led by chief executive Daniel Gil, with co-founder and president William Lowry5.
Most of what is publicly known about PP405’s results comes from the company or its backers. The earlier study results reached Biohack through a company press release reprinted on an investor’s website3. The main independent critique, the Anagen review, comes from a firm that sells other hair-loss treatments6.
How it fits the field and what to watch
Hair loss is common. Pelage’s chief executive has said it affects more than 80% of men and 40% of women during their lives5. He also said no new FDA-approved option has arrived in decades5. GV’s Friedman said women have only one FDA-approved option5. Other approaches are also moving through trials; Biohack recently covered a daily pill for male hair loss that its maker says passed a second big trial.
Things to watch for PP405:
- A full, peer-reviewed report of the earlier 78-person study. Pelage had said it planned to present the full dataset at a major medical conference in 20265.
- Progress in enrolling AWAKEN’s roughly 600 men and any interim updates2.
- The start of the separate trial in women, promised by the end of 20261.
- Main AWAKEN results, with data collection listed for December 20272.
