PP405 Explained: Pelage Clinical Trials & Status 2026

Research use only. This article summarises public information about PP405, an investigational product of Pelage Pharmaceuticals. PP405 is not approved anywhere. JXL-069, sold on this site for laboratory research, is a separate research compound: it is not approved and has no human safety data, and PP405 trial results do not apply to it.

What is PP405?

PP405 is a topical small molecule developed by Pelage Pharmaceuticals, a company founded on research from UCLA. Pelage describes it as a non-invasive topical small molecule designed to reactivate dormant hair follicle stem cells. Its mechanism is inhibition of the mitochondrial pyruvate carrier (MPC). Pelage has not published the chemical structure of PP405.

Who is behind PP405?

Pelage was founded by UCLA scientists William Lowry, Heather Christofk and Michael Jung, whose labs published the mouse research on lactate and hair follicle stem cells (Flores et al., 2017) and the MPC inhibitor series that includes JXL069 (Liu et al., 2021). According to Pelage, the intellectual property behind PP405 and related topical molecules was licensed from UCLA in 2018.

Pelage has announced three financing rounds: a $16.75 million Series A led by GV in February 2024, a $14 million Series A-1 led by GV in August 2024, and a $120 million Series B co-led by ARCH Venture Partners and GV in October 2025.

Phase 1b and early human data

In March 2024, Pelage presented late-breaking data at the American Academy of Dermatology meeting. According to the company, its Phase 1b study in people with androgenetic alopecia showed that daily 0.05% PP405 applied to the scalp was well tolerated with no detectable drug in the blood, and that after seven days biopsies showed a significant increase in the proliferation marker Ki67 compared with baseline. In human scalp tissue tested ex vivo, PP405 increased lactate dehydrogenase activity in hair follicle stem cells within 24 hours. These are company-reported findings, not a peer-reviewed publication.

Phase 2a trial results

The Phase 2a trial (ClinicalTrials.gov NCT06393452) was randomised, double-blind and vehicle-controlled. It enrolled 78 men and women aged 18 to 55 with androgenetic alopecia. Participants applied PP405 0.05% gel or a placebo gel to the scalp once daily for 4 weeks and were followed up to 12 weeks.

  • Safety: according to Pelage, the trial met its primary safety endpoint and its pharmacokinetic endpoint. PP405 was well tolerated and no systemic absorption was detected in the blood.
  • Efficacy: Pelage reported that at week 8, four weeks after treatment ended, 31% of PP405-treated men with a higher degree of hair loss showed a greater than 20% increase in hair density, compared with 0% in the placebo group.
  • That efficacy figure comes from a subgroup, was announced in a company press release in June 2025, and has not been published in a peer-reviewed journal.
  • The results posted on ClinicalTrials.gov in September 2026 cover safety and pharmacokinetics. No serious adverse events were recorded in the PP405 group (one occurred in the placebo group), and the most common side effects were itching and redness at the application site.

What comes next: the AWAKEN trial

Pelage said it expected to start Phase 3 studies in 2026. In September 2026, a Phase 2/3 trial called AWAKEN (NCT07819435) was registered on ClinicalTrials.gov. It plans to enrol about 600 men aged 18 to 55 with androgenetic alopecia, compares PP405 0.05% gel with a vehicle gel, and uses the change in non-vellus hair count in a target area as its primary outcome. At registration it was not yet recruiting, with an estimated primary completion date of December 2027.

What PP405 has not shown yet

  • No peer-reviewed human efficacy data have been published.
  • Long-term safety has not been reported; AWAKEN is designed to study it.
  • The Phase 2a efficacy figure applies to a subgroup of men and to a short treatment period.
  • PP405 is not approved and is not available as a medicine.

How PP405 relates to JXL-069

Both come from the same UCLA MPC research. In 2026 the WHO proposed the name suvomipic for an MPC inhibitor with exactly the structure published for JXL069, but Pelage has not officially linked PP405 to that name or to any structure. We cover the details in JXL-069 vs PP405 and What is JXL-069?.

For laboratory work on MPC inhibition: JXL-069 (PP405 comparison compound) 0.05% w/v 30mL and JXL-069 raw powder, for research use only.

References

  1. Pelage Pharmaceuticals. Pelage Pharmaceuticals Announces Positive Phase 2a Clinical Trial Results for PP405 in Regenerative Hair Loss Therapy. Press release, 17 June 2025. pelagepharma.com
  2. Pelage Pharmaceuticals. Pelage Presents Late-Breaking Data at AAD 2024 Meeting. Press release, 9 March 2024. pelagepharma.com
  3. Pelage Pharmaceuticals. Press releases on financing: 27 February 2024, 13 August 2024 and 15 October 2025. pelagepharma.com/press-releases
  4. ClinicalTrials.gov. NCT06393452: Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA (Phase 2a). clinicaltrials.gov
  5. ClinicalTrials.gov. NCT07819435: Phase 2/3 Efficacy and Safety of PP405 in Adult Males (AWAKEN). clinicaltrials.gov
  6. Flores A, Schell J, Krall AS, et al. Lactate dehydrogenase activity drives hair follicle stem cell activation. Nat Cell Biol. 2017;19(9):1017-1026. doi:10.1038/ncb3575
  7. Liu X, Flores AA, Situ L, et al. Development of Novel Mitochondrial Pyruvate Carrier Inhibitors to Treat Hair Loss. J Med Chem. 2021;64(4):2046-2063. doi:10.1021/acs.jmedchem.0c01570

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