Medically reviewed by Dr. Levent Acar, MD
Founder & Lead Hair Transplant Surgeon
Updated on: October 29, 2026
What’s new (October 2026): Pelage Pharmaceuticals has dosed the first patient in AWAKEN, a Phase 2/3 trial of PP405 in about 600 men. We have updated the timeline, results and FAQ below.
PP405 (suvomipic) is an experimental topical gel from Pelage Pharmaceuticals that aims to reactivate dormant hair follicle stem cells. As of October 2026 it is not approved or sold anywhere: it is in a 12-month Phase 2/3 trial, so it is not expected to reach patients before the end of the decade.
Early results have drawn attention because PP405 works differently from minoxidil and finasteride. In a small Phase 2a trial, some men with advanced hair loss saw a measurable density increase after only four weeks of treatment. Below, we explain how PP405 works, what the trials have shown, when it could realistically launch, and what you can do about hair loss today.
| Name | PP405; proposed generic name suvomipic |
|---|---|
| Developer | Pelage Pharmaceuticals (UCLA spin-out, backed by GV and ARCH Venture Partners) |
| Type | Non-hormonal topical small molecule (0.05% gel), not a peptide |
| Target | Androgenetic alopecia (male and female pattern hair loss) |
| Current stage | Phase 2/3 AWAKEN trial in men, started October 2026 |
| FDA status | Not approved |
| Can you buy it? | No. Anything sold online as PP405 is unregulated |
| Earliest realistic availability | Around 2029–2030, if trials succeed (our estimate) |
What is PP405 (suvomipic)?
PP405 is an investigational, non-hormonal topical drug for androgenetic alopecia, the most common of the many causes of hair loss in men and women. It is applied to the scalp as a 0.05% gel. In 2026 it received the proposed international non-proprietary name suvomipic, so you may see both names.
PP405 is developed by Pelage Pharmaceuticals, a company founded in 2018 to commercialise research from the University of California, Los Angeles (UCLA). Its scientific founders are Bill Lowry, Heather Christofk and Michael Jung. Pelage has raised more than $150 million, including a $120 million Series B in October 2025 co-led by ARCH Venture Partners and GV (formerly Google Ventures). That backing is why PP405 is sometimes called “Google’s hair loss drug”.
Unlike finasteride, PP405 does not block DHT, the hormone behind pattern hair loss (how DHT causes hair loss). Unlike minoxidil, it is not a vasodilator. It targets the metabolism of the hair follicle stem cells themselves.
How does PP405 work?
PP405 aims to wake up dormant hair follicles by changing how their stem cells produce energy. It does not create new follicles.
Each hair follicle cycles through three phases: growth (anagen), transition (catagen) and rest (telogen). In pattern hair loss, follicles gradually shrink (miniaturise) and spend longer resting. Many of them are not dead. Their stem cells are still present but no longer switch back into growth.
UCLA researchers found that these stem cells need to raise their production of lactate to start a new growth phase. PP405 blocks the mitochondrial pyruvate carrier (MPC), the “door” that lets pyruvate into the cell’s mitochondria. Pyruvate then builds up and is converted into lactate by the enzyme lactate dehydrogenase (LDH). Higher lactate is associated with the growth phase, so the stem cells are nudged back into producing hair.
In Pelage’s Phase 1 study, one week of treatment produced a statistically significant rise in Ki67, a marker that stem cells are dividing. This was the first sign in people that the mechanism works as intended.
PP405 trial update (October 2026): the AWAKEN study
On 14 October 2026, Pelage announced that the first patient had been dosed in AWAKEN, a Phase 2/3 trial of PP405. This is the late-stage study that will decide whether PP405 can move towards FDA approval. It began after what Pelage describes as a positive end-of-Phase 2 meeting with the FDA.
| AWAKEN trial | Details |
|---|---|
| Phase | Phase 2/3 |
| Design | Randomised, double-blind, placebo-controlled |
| Duration | 12 months |
| Participants | About 600 adult men with Norwood-Hamilton type IV or V hair loss |
| Locations | United States and Canada |
| Main measures | Change in non-vellus (terminal) hair count in a target area, patient-reported outcomes, follicle reactivation, long-term safety |
| Registry ID | NCT07819435 |
Two details matter for readers. First, AWAKEN enrols men with moderate-to-advanced hair loss (Norwood IV–V), the group that responded best in Phase 2a (see where you sit on the Norwood scale). Second, it uses non-vellus hair counts, which measure thicker, visible hairs rather than fine “peach fuzz”. If PP405 meets this endpoint, the regrowth should be cosmetically meaningful.
Pelage also expects to start a separate Phase 2 trial in women with androgenetic alopecia by the end of 2026, and has said further trials in men and women are planned.
How to join a PP405 trial
AWAKEN recruits at study sites in the US and Canada. Search for NCT07819435 on ClinicalTrials.gov to see eligibility criteria and participating sites. Only the official trial sites can give you PP405 legitimately.
When will PP405 be available?
PP405 is unlikely to be available before around 2029–2030, and only if AWAKEN and any follow-up trials succeed. Pelage has not announced a launch or approval date.
Here is why. AWAKEN treats patients for 12 months and has to recruit about 600 men first, so results are unlikely before 2028. If they are positive, the FDA review of a new drug typically takes around a year after the application is filed. Approval in Europe, the UK or the Middle East would usually come later than in the US.
| Milestone | Date | Status |
|---|---|---|
| Phase 1: stem cell activation shown (Ki67) | Reported Feb–Mar 2024 | Done |
| Phase 2a: first patients dosed (78 men and women) | Aug 2024 | Done |
| Phase 2a results announced | Jun 2025 | Done |
| $120M Series B to fund late-stage trials | Oct 2025 | Done |
| Suvomipic name published | Jul 2026 | Done |
| AWAKEN Phase 2/3: first patient dosed | 14 Oct 2026 | Recruiting |
| Phase 2 trial in women begins | Expected end of 2026 | Planned |
| AWAKEN results | Not before 2028 (our estimate) | Not announced |
| FDA decision | Around 2029–2030 at the earliest (our estimate) | Not announced |
Treat any website or social media post promising PP405 “next year” with caution. Estimates published before AWAKEN started, including 2027, are no longer realistic.
What did the Phase 2a trial find?
In Pelage’s Phase 2a trial, 31% of men with more advanced hair loss who used PP405 had a hair density increase of more than 20% at week 8, compared with 0% on placebo. These are preliminary, company-reported figures from a small trial that was designed mainly to test safety.
Phase 2a Trial Snapshot
| Phase 2a trial | Details |
|---|---|
| Registry ID | NCT06393452 |
| Participants | 78 men and women with androgenetic alopecia, across a range of skin types and hair textures |
| Design | Randomised, double-blind, placebo-controlled |
| Treatment | PP405 0.05% gel or placebo, once daily for 4 weeks |
| Follow-up | To week 12, plus an optional 3-month open-label safety extension |
| Primary goal | Safety and how much drug enters the bloodstream |
| Headline result | 31% vs 0% of men with more advanced hair loss reached >20% density gain at week 8 |
Pelage also reported new hair growth from follicles where no hair had been visible, and more thicker (terminal) hairs in the PP405 group, while gains on placebo were limited to fine vellus hair.
Three caveats keep these results in perspective:
- Small numbers. Pelage has not published how many men were in the advanced-hair-loss subgroup, so the 31% cannot be checked against a denominator.
- Not peer-reviewed. The data come from press releases and conference presentations, not a published journal article.
- Short treatment. Patients used PP405 for only 4 weeks. Whether gains last or grow with longer use is exactly what AWAKEN will test.
“What’s compelling about PP405 is that it brings scientific rigor to a space that’s needed it for decades,” said Dr. Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation at Brigham and Women’s Hospital and a Pelage advisory board member.
PP405 before and after: what has actually been published?
The only verified PP405 before-and-after results come from Pelage’s own trial presentations. Pelage presented Phase 2a findings at the American Academy of Dermatology meeting in March 2026. There are no independent, published before-and-after photo series yet.
[Editor: embed Pelage trial images only with written permission, credited “Image: Pelage Pharmaceuticals”. Otherwise link to Pelage’s press page.]
Be sceptical of “PP405 before and after” photos on social media, forums or seller websites. PP405 has only been given to trial participants, so these photos cannot be verified and often show other products or treatments.
If you want to see what is achievable for advanced hair loss today, look at real hair transplant before and after results instead. These show a different treatment, not PP405.
Is PP405 safe? Side effects so far
So far, PP405 has been well tolerated in trials, with no systemic absorption and no treatment-related systemic side effects reported. Both the Phase 1 and Phase 2a trials met their primary safety goals.
Because no PP405 was detected in participants’ blood, it is not expected to cause the whole-body side effects associated with oral finasteride. That said, only small numbers of people have used it in reported trials, and only for weeks. Rare or long-term side effects cannot be ruled out until larger, longer studies such as AWAKEN report.
Can you buy PP405? Peptides, serums and "research chemicals"
No. As of October 2026, PP405 is not approved or legally sold anywhere in the world, and the only legitimate way to receive it is as a participant in an official clinical trial.
Search interest has created a grey market. Some websites sell products labelled “PP405”, “PP405 peptide”, “PP405 serum” or “research chemical”. Before you buy, know this:
- PP405 is not a peptide. It is a small molecule. A product sold as a “PP405 peptide” is, by definition, not what was tested in Pelage’s trials.
- Contents are unverified. These products are not made or approved by Pelage, and no regulator has checked their identity, purity or dose.
- “Research use only” labels are a warning, not a guarantee. They mean the product is not intended for people. The same applies to other grey-market hair loss compounds such as RU58841.
- Pelage does not endorse them. The company has publicly distanced itself from unofficial versions of its compound.
Applying an unregulated chemical to your scalp carries real risks, from irritation to contamination, with no proven benefit. If you want access to PP405, check the trial registry instead.
Does PP405 work for women?
PP405 is being developed for both men and women, but there is not yet enough data to say how well it works in women. The Phase 2a trial included women, but the headline 31% result was reported for men with advanced hair loss.
Pelage expects to start a dedicated Phase 2 trial in women with androgenetic alopecia by the end of 2026. Because PP405 is non-hormonal, it could become a useful option for women who cannot or prefer not to use hormone-based treatments. Until then, women with thinning hair have other proven options, including hair transplant for women where thinning is stable.
Dormant vs. dead hair follicles: why the distinction matters
| Dormant follicle | Destroyed follicle | |
|---|---|---|
| What it is | Stem cells present but not growing hair | Stem cells and follicle structure gone |
| Typical cause | Androgenetic alopecia (miniaturisation), stress | Long-standing baldness, scarring alopecia, injury |
| Can PP405 help? | Potentially, by restarting growth | No |
| Can a transplant help? | Yes, if needed | Yes, by moving healthy follicles from the donor area |
In practice, most people with pattern hair loss have a mix of both. That is why a scalp assessment matters before deciding whether to wait for new drugs. If a transplant is an option, our guide explains how many grafts you may need.
Why hair transplants still lead for advanced hair loss
Where follicles are gone, no drug, including PP405, can regrow hair. A hair transplant moves healthy, DHT-resistant follicles from the back of the scalp to the thinning areas, where they usually keep growing long term.
At Cosmedica, Dr. Levent Acar’s team uses Micro Sapphire DHI. Grafts are extracted with micro punches, recipient channels are opened with fine sapphire blades, and grafts are placed with a DHI implanter pen to control angle, direction and density.
Hair transplants in Turkey and regenerative treatments are not rivals. If PP405 is approved, it may become a way to protect and strengthen native hair around transplanted areas, just as minoxidil and finasteride are used today.
PP405 is one of the most interesting developments in hair loss research, and we follow the AWAKEN trial closely. But it will not replace surgery where follicles are gone. For most of our patients, the right question is not 'should I wait?' but 'what can I protect now, and what needs restoring?'"
How does PP405 compare with existing treatments?
| PP405 (suvomipic) | Minoxidil | Finasteride | Hair transplant (FUE/DHI) | |
|---|---|---|---|---|
| How it works | Reactivates dormant follicle stem cells (MPC inhibition) | Prolongs growth phase, improves blood flow | Blocks conversion of testosterone to DHT | Moves healthy follicles to thinning areas |
| Form | Topical gel | Topical or oral | Oral or topical | Surgical procedure |
| Hormonal? | No | No | Yes | No |
| Time to visible change | Signals at 8 weeks in Phase 2a | Several months [Editor: add sourced figure] | Several months [Editor: add sourced figure] | Growth from a few months; final result around 12 months [Editor: match Cosmedica recovery page] |
| Approval status | Not approved; in Phase 2/3 | Approved | Approved | Established medical procedure |
| Works where follicles are gone? | No | No | No | Yes |
| Best for | Possibly early-to-moderate loss with dormant follicles (if approved) | Slowing loss, mild regrowth | Slowing loss in men | Established bald or thinning areas |
AMP-303 is another investigational hair loss drug in development. Like PP405, it is not yet available. Regenerative options you can use today include Regenera Activa and exosome therapy, though the evidence behind each differs.
Should you wait for PP405?
For most people, waiting is not the best strategy. PP405 is at least three to four years from possible approval, and pattern hair loss usually keeps progressing in the meantime. Follicles that are dormant today may be lost by then.
A sensible approach is to:
- Find out your hair loss stage, using the Norwood scale for men or the Ludwig scale for women.
- Talk to a doctor about proven treatments that slow loss now.
- Consider a transplant if you have areas where follicles are already gone.
- Keep following PP405, which could later help protect the hair you have.
Frequently Asked Questions
What is PP405?
PP405 (suvomipic) is an experimental topical gel from Pelage Pharmaceuticals for pattern hair loss. It aims to reactivate dormant hair follicle stem cells by blocking the mitochondrial pyruvate carrier. As of October 2026 it is in Phase 2/3 trials and not approved.
Is PP405 approved by the FDA?
No. As of October 2026, PP405 is not approved by the FDA or any other regulator. It is being tested in the Phase 2/3 AWAKEN trial, which started in October 2026.
When will PP405 be available?
Pelage has not announced a launch date. Because the AWAKEN trial runs for 12 months and only started in October 2026, our estimate is that PP405 could not be approved before around 2029–2030, and only if the trials succeed.
Is PP405 in Phase 3?
Yes, in effect. AWAKEN is a combined Phase 2/3 trial in about 600 men with Norwood IV–V hair loss, and the first patient was dosed on 14 October 2026.
Can I buy PP405 online?
No. PP405 is not approved or legally sold anywhere as of October 2026. Products sold online as PP405, PP405 peptide or PP405 serum are unregulated and are not made by Pelage.
Is PP405 a peptide?
No. PP405 is a small-molecule drug, not a peptide. Products marketed as a “PP405 peptide” are not the compound tested in clinical trials.
What is suvomipic?
Suvomipic is the proposed generic (international non-proprietary) name for PP405, published in 2026. PP405 is the development code; suvomipic is the name it would carry as an approved medicine.
Does PP405 regrow hair in completely bald areas?
Only where follicles are dormant rather than gone. Phase 2a reported some new growth from follicles with no visible hair, but PP405 cannot recreate follicles lost to long-standing baldness or scarring.
Does PP405 work for women?
It is being developed for women too, and women took part in the Phase 2a trial. A dedicated Phase 2 trial in women is expected to start by the end of 2026, so results in women are not yet known.
What are PP405’s side effects?
In trials so far, PP405 was well tolerated, with no systemic absorption and no treatment-related systemic side effects reported. Long-term safety is still being studied in AWAKEN.
How is PP405 different from minoxidil or finasteride?
Finasteride lowers DHT, and minoxidil prolongs the growth phase and improves blood flow. PP405 is non-hormonal and targets the energy metabolism of follicle stem cells to restart growth.
Can PP405 replace a hair transplant?
No. PP405 may help dormant follicles, but a transplant is still the only way to restore hair where follicles are gone. In future, the two could be combined.
How can I join a PP405 clinical trial?
Search for NCT07819435 (AWAKEN) on ClinicalTrials.gov. It recruits men with Norwood IV–V hair loss at sites in the US and Canada.
Who makes PP405?
Pelage Pharmaceuticals, a company founded in 2018 to develop research from UCLA. It is backed by investors including GV (formerly Google Ventures) and ARCH Venture Partners.
Sources
- Pelage Pharmaceuticals: First patient dosed in Phase 2/3 AWAKEN trial (14 Oct 2026)
- Pelage Pharmaceuticals: Positive Phase 2a results (Jun 2025)
- Pelage Pharmaceuticals: $120M Series B (Oct 2025)
- Pelage Pharmaceuticals: Phase 1 data at AAD 2024
- Dermatology Times: PP405 moves toward late-stage trials (Mar 2026)
- Suvomipic (Wikipedia) [Editor: replace with the WHO INN list entry if available]
- Liu X et al. Development of novel mitochondrial pyruvate carrier inhibitors to treat hair loss. J Med Chem. 2021;64(4):2046–2063.
- gov: NCT06393452 (Phase 2a) and NCT07819435 (AWAKEN)