PP405 for Hair Loss: Trial Results and 2026 Status

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PP405 is an experimental topical gel for pattern hair loss (androgenetic alopecia), developed by Pelage Pharmaceuticals. Instead of blocking hormones like finasteride, it is designed to wake up dormant hair follicle stem cells. It is not approved anywhere and cannot be prescribed. A small phase 2a trial in 78 people found it well tolerated over four weeks of use, and the company reported early signs of regrowth. A larger phase 2/3 trial called AWAKEN started in September 2026 in about 600 men in the US and Canada, and its main results are not expected before 2028.

By ForumHairTransplant Editorial Team · Prepared with AI assistance · Sources checked: 6 November 2026

Key takeaways

  • PP405 is still an investigational drug. You cannot buy it legally, and anything sold online under that name is not the trial product.
  • The phase 2a trial was small and short: 78 adults, once-daily use for four weeks, with follow-up to week 12.
  • Its main goal was safety, which it met. The headline regrowth figure (31% of men with more advanced loss gaining over 20% in hair density at week 8) comes from the company and has not yet been confirmed in a larger trial.
  • AWAKEN, the first large trial, compares PP405 with a placebo gel for 24 weeks in men aged 18 to 55 with Norwood IV or V hair loss. Women are not included.
  • Do not stop a treatment that is working for you while you wait for PP405. Talk to a doctor about the options available now.

What PP405 is and how it is meant to work

PP405 is a small molecule applied to the scalp as a gel. Pelage licensed it from the University of California, Los Angeles (UCLA) in 2018. The company describes it as targeting the metabolism of hair follicle stem cells: in pattern hair loss, many follicles in thinning areas are thought to be dormant rather than gone, and the idea is to switch them back into a growth phase.

That is a different approach from the two most widely used treatments. Finasteride lowers the hormone that drives pattern hair loss, and minoxidil prolongs the growth phase of follicles that are still active. If PP405 works as intended, it could in theory be combined with them, but that has not been tested.

What the phase 2a trial found

The phase 2a study (ClinicalTrials.gov NCT06393452) was randomised, double-blind and compared PP405 with a placebo gel (vehicle). It enrolled 78 men and women aged 18 to 55 with androgenetic alopecia. Participants applied the gel once a day for four weeks and were then followed for another eight weeks.

Safety, the main goal. PP405 met its primary safety endpoint. The company reported no PP405 detected in the blood. The results posted on ClinicalTrials.gov show that 22 of 51 people on PP405 and 10 of 27 on the placebo gel had at least one adverse event during the randomised period, with no serious adverse events in the PP405 group and one in the placebo group.

Hair growth, an exploratory result. In June 2025 Pelage reported that, at week 8, 31% of men with more extensive hair loss who used PP405 had a greater than 20% increase in hair density, compared with 0% on placebo. The company also reported new hair growing from follicles where no hair had been visible. At the American Academy of Dermatology meeting in March 2026 it presented further data on hair growth from dormant follicles.

What to keep in mind. The trial was small, the treatment lasted only four weeks, and the growth figures came from a subgroup and were announced by the company. As far as we could find, the full efficacy results had not been published in a medical journal at the time of writing. A larger trial is needed to show whether the effect is real, how big it is and whether it lasts.

The AWAKEN phase 2/3 trial

Detail AWAKEN (NCT07819435)
Design Randomised, double-blind, placebo (vehicle) gel controlled
Participants About 600 men aged 18 to 55
Hair loss Modified Norwood-Hamilton IV or V, for at least 6 months
Treatment PP405 0.05% gel or vehicle gel for 24 weeks, then a second period to week 52
Main measure Change in the number of non-vellus (thicker) hairs in a target area at the crown, at week 24
Start 21 September 2026 (recruiting)
Sites 63 sites in the United States and Canada
Estimated primary completion December 2027

People taking other hair loss treatments are excluded for periods set out in the protocol, so joining would usually mean pausing finasteride or minoxidil. Discuss that with your doctor before applying.

What this means if you are losing hair now

  • There is no PP405 to buy. It is only available inside clinical trials. Products sold online with similar names are not the trial drug and have not been tested in the same way.
  • Proven treatments still matter. Finasteride and minoxidil have years of data behind them. If your hair loss is progressing, a doctor can tell you whether they suit you. See Do You Need Finasteride After a Hair Transplant? and When Can I Restart Minoxidil After a Hair Transplant?.
  • Waiting has a cost. Hair lost while waiting for a future drug may not come back. Planning around a treatment that has not finished its trials is a gamble.
  • Want to take part in a trial? Search for NCT07819435 on ClinicalTrials.gov to see the eligibility criteria and the sites near you.

PP405 and hair transplants

A hair transplant moves follicles from the back of the head to thinning areas. PP405 aims to reactivate follicles that are already there but dormant. The two do different things, and there is no data yet on using them together or on whether PP405 could reduce the need for surgery. For now, the decision about a transplant should be based on treatments that are available today. Our guide to the Norwood scale explains how surgeons plan around the stage of hair loss.

Common questions

When will PP405 be available?
Nobody knows. AWAKEN’s main measurement is at 24 weeks and the estimated primary completion date is December 2027. After that the results have to be analysed and reviewed by regulators before any approval.

Does PP405 work for women?
Women took part in the phase 2a safety trial, but the headline growth result was reported for men, and AWAKEN only includes men. There is no answer yet for women.

Can it regrow hair on areas that have been bald for many years?
That has not been shown. The approach depends on dormant follicles still being present, and it is not known how long they remain able to respond.

Discussion

Are you following the PP405 trials, or have you taken part in one? Share what you know, and which questions you would want answered before trying a new treatment like this.

Sources

Most of the efficacy data so far comes from the company. The safety figures and the AWAKEN design come from the trial records on ClinicalTrials.gov.

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About this guide: ForumHairTransplant.com is an independent patient community. We are not affiliated with any clinic, surgeon or drug company, and we don’t accept payment for rankings, reviews or recommendations. This article is general information, not medical advice. Talk to a qualified doctor about your own situation.

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