Important Update: Exciting Progress on PP405, But Remember—Time Equals Follicles (September 2025)

Since our original post on the promising Phase 1 results for Pelage Pharmaceuticals’ PP405, there’s been significant buzz—and for good reason. In June 2025, the company announced positive outcomes from their Phase 2a clinical trial, a randomized, double-blind study involving 78 adults with androgenetic alopecia (AGA). Participants applied a 0.05% topical PP405 gel once daily, and the results are encouraging: about 31% of those with more advanced hair loss saw over a 20% increase in hair density after just 8 weeks, compared to none in the placebo group. Even more intriguing, PP405 appeared to spark new hair growth in previously bald areas by reactivating dormant stem cells through enhanced mitochondrial activity and lactate production. Safety-wise, it met all primary endpoints with no detectable systemic absorption and was generally well-tolerated, paving the way for Phase 3 trials slated to begin in 2026.

This is genuinely exciting news—it validates the regenerative approach we’ve been watching closely and could represent a meaningful advancement over existing options like minoxidil or finasteride, potentially offering faster, more targeted results with fewer side effects for some patients. We’re optimistic about its future, as it aligns with the cutting-edge science that’s transforming hair restoration.

However, if you’re a Bauman Medical patient (or anyone battling AGA) tempted to hit “pause” on your current treatment plan while waiting for PP405 to hit the market—stop right there. This hype, while understandable, is leading too many to delay proven therapies, and that’s a dangerous gamble. Phase 3 trials won’t wrap up until at least 2027 or later, followed by FDA review, which could push availability to 2028 or beyond. History is littered with “miracle” hair loss candidates that showed early promise but faltered in larger studies—think of the Wnt pathway drugs or early stem cell injectables that never made it to shelves. Even if PP405 succeeds (and we hope it does), it won’t reverse follicles that have already miniaturized beyond repair during years of waiting.

Consider this real story from our clinic: A 35-year-old patient we’ll call Mark came in after putting off treatment for two years, chasing rumors of upcoming “cures.” By then, his crown had progressed from Norwood 3 to 5, and while we stabilized what remained with a combo of finasteride, minoxidil, and laser therapy, he lost follicles he could have saved. Mark now regrets it deeply: “I wish I’d acted sooner—time really does equal follicles.”

Don’t let that be you. AGA is progressive; every month without intervention means more follicles shrinking, potentially to the point where even breakthrough drugs like PP405 can’t revive them. Start or continue evidence-based treatments today—they can halt loss, promote regrowth, and buy you time for innovations like this to mature. If PP405 proves out, you’ll be in a stronger position to benefit from it.

Ready to protect your hair? Schedule an evaluation with us now for a personalized plan. Your follicles aren’t waiting—neither should you.

Pelage PP405 Advances Hair Loss Treatment with Phase 2a Trial Results

Unlocking Hair Growth: The Next Frontier in PP405’s Stem Cell Activation

Pelage Pharmaceuticals Showcases Promising Phase 2a Data at AAD 2025 Meeting, Demonstrating PP405’s Efficacy in Stimulating Hair Follicle Stem Cells for Androgenetic Alopecia (June 2025)

Pelage Pharmaceuticals presented groundbreaking updates on their novel hair loss treatment, PP405, at the 2025 American Academy of Dermatology (AAD) meeting. This topical small-molecule therapy targets dormant hair follicle stem cells through a metabolic pathway involving mitochondrial pyruvate carriers. By upregulating lactate dehydrogenase (LDH), PP405 activates these stem cells, promoting the transition of hair follicles from the resting (telogen) phase to the growth (anagen) phase.

Key Findings from Phase 2a Clinical Trials

The ongoing Phase 2a clinical trials, initiated in mid-2024, build on the success of the 2023 Phase 1 trial. These trials focus on evaluating PP405’s efficacy and safety in patients with androgenetic alopecia (male and female pattern baldness). Key highlights include:

• Efficacy in Hair Growth: PP405 demonstrated statistically significant increases in terminal hair growth within weeks of topical application, with some patients showing visible results as early as one week. This rapid response is attributed to the drug’s ability to reactivate dormant follicles.
• Safety Profile: The treatment remains well-tolerated, with no systemic absorption detected in the blood, minimizing the risk of side effects. This contrasts with existing treatments like finasteride, which has faced scrutiny for side effects such as sexual dysfunction or psychological impacts.
• Cellular Engagement: Similar to Phase 1 findings, PP405 significantly increased Ki67, a marker of cell proliferation, within seven days, confirming robust activation of hair follicle stem cells. Phase 2a data further validated these cellular changes across a broader patient cohort.
• Broad Applicability: Preliminary results suggest PP405 may benefit patients with telogen effluvium (stress-induced hair loss) and chemotherapy-induced alopecia, expanding its potential beyond androgenetic alopecia.

Advancements Since 2024

Compared to the Phase 1 trial results presented at AAD 2024, the 2025 data reflect significant progress:

• Efficacy Focus: While Phase 1 established safety and initial cellular changes, Phase 2a trials provide concrete evidence of hair regrowth, with measurable increases in hair density and thickness.
• Larger Cohort: The current trials include a more diverse demographic, strengthening the case for PP405’s effectiveness across genders and age groups.
• Market Timeline: Pelage Pharmaceuticals projects that, pending successful trial outcomes, PP405-based treatments could reach the market between 2027 and 2030, offering a non-invasive alternative to current therapies.

A New Era for Hair Loss Treatment

PP405’s unique mechanism sets it apart from traditional treatments like minoxidil and finasteride. By directly targeting hair follicle stem cells via mitochondrial pathways, it offers a faster, safer, and potentially more effective solution for hair loss. The drug’s lack of systemic absorption reduces risks associated with hormonal or systemic side effects, positioning it as a game-changer in alopecia care.

Pelage Pharmaceuticals, backed by Google Ventures, plans to continue Phase 2a trials through 2025, with further data expected to refine dosing and long-term outcomes. The company is also exploring applications for PP405 in eyebrow and eyelash restoration, broadening its cosmetic and therapeutic potential.

Looking Ahead

PP405 represents a significant leap forward in hair restoration, offering hope to millions affected by hair loss. As Phase 2a trials progress, Pelage Pharmaceuticals is poised to redefine the standard of care for alopecia, with a focus on safety, efficacy, and accessibility.

SOURCE: Pelage Pharmaceuticals

Bauman Medical is tracking these updates with great enthusiasm and hope as a future therapy for hair loss.

Unlocking Hair Growth: The Groundbreaking Science Behind PP405’s Stem Cell Activation

Pelage Presents Late-Breaking Data at AAD 2024 Meeting Demonstrating PP405 Activates Human Hair Follicle Stem Cells Ex Vivo and in Phase 1 Clinical Study

March 2024

Pelage Pharmaceuticals presented promising results at the 2024 AAD meeting for their novel hair loss treatment, PP405. This small molecule therapy targets dormant hair follicle stem cells through a metabolic pathway involving mitochondrial pyruvate carriers. The mechanism involves upregulating lactate dehydrogenase (LDH), which in turn activates these stem cells, stimulating hair growth.

Key findings from their Phase 1 clinical trial showed that PP405 is safe and effective. It was well-tolerated by patients with androgenetic alopecia, achieving the target pharmacokinetic profile without detectable drug levels in the blood. Notably, there was a statistically significant increase in Ki67, a marker of cell proliferation, within just seven days of use, indicating active hair follicle stem cell engagement. This early data suggests the treatment might transition hair follicles from a resting phase to a growing phase.

PP405’s potential extends beyond androgenetic alopecia to possibly benefit those with stress-induced hair loss (telogen effluvium) and chemotherapy-induced alopecia. Pelage Pharmaceuticals plans to start a Phase 2a trial in mid-2024, further exploring PP405’s efficacy and safety across different demographics.

Overall, PP405 represents a significant advancement in alopecia treatment, offering a new approach that directly targets hair follicle stem cells to stimulate hair growth. This could be a breakthrough for hair loss patients, offering a new, non-invasive option for restoring hair growth.

SOURCE Pelage Pharmaceuticals

PR Newswire

If you or someone you know has hair loss, hair thinning, baldness, or eyebrow / eyelash concerns, click to start either a long-distance virtual consultation OR an in-person, in-office consultation with Dr. Bauman. You can also Ask Dr. Bauman a Question or simply call Bauman Medical Group  at +1-561-394-0024.

*Each individual's treatment and/or results may vary

Unlocking Hair Growth:
The Groundbreaking Science
Behind Pelage’s PP405’s Stem Cell Activation