on August 04, 2025
In an industry long dominated by hormone-based therapies and circulatory boosters, PP405, an experimental topical molecule by Pelage Pharmaceuticals, stands out for targeting the metabolic root of hair thinning, offering what may be the first true regenerative remedy in androgenetic alopecia for both men and women.
A Metabolic Switch That Reactivates Dormant Follicles
- Inhibiting the Mitochondrial Pyruvate Carrier (MPC): PP405 acts directly on scalp follicle stem cells by suppressing MPC, triggering a metabolic shift to glycolysis, activating cells previously dormant in balding areas. Rather than blocking hormones or increasing blood flow, it targets the primary driver of hair cycling.
- Localised formulation: Developed to penetrate into scalp follicles with minimal absorption beyond the target site. Phase 1 data showed undetectable drug levels in blood outside the scalp, as well as early biological signs of stem-cell activation in tissue biopsies.
This science-based pathway represents a significant departure from existing treatments that manage symptoms instead of reawakening dormant follicles.
Phase 2a Trial: Regrowth Shown in Just 8 Weeks
Study design (NCT06393452): A randomised, double-blind, vehicle‑controlled study of 78 adults (both genders, aged 18–55) applied 0.05% PP405 topically once daily for 4 weeks, with follow‑up through 12 weeks.
Virtual Regrowth: At 8 weeks, 31% of men with more advanced patterning saw ≥20% improvements in hair density, compared with 0% in the placebo group. Importantly, some subjects grew new hair in sites that were previously bare, pointing to true regeneration, not just follicle thickening.
Safety and tolerability: No serious adverse events, no systemic absorption, and mild local reactions such as itching or dryness, present equally across test and placebo groups, confirming a promising safety profile.
Fast-Response Advantage: In typical therapies like minoxidil or finasteride, visible results often take 6–12 months. PP405 showed clinical effect in just 8 weeks in a subset of participants.
Expert Validation & Company Backing
Dr Arash Mostaghimi (Brigham & Women’s Hospital & Pelage advisory board member):
“What’s compelling about PP405 is that it brings scientific rigor to a space that’s needed it for decades. A well‑tolerated, topically delivered therapy that shows measurable biological activity this early is rare.”
Dr Christina Weng, Chief Medical Officer of Pelage:
“These early clinical results reinforce the potential… to directly drive hair follicle regeneration.”
Funding & next phase: Pelage has raised approximately US $16–17 million in Series A and A‑1 funding, led by GV (Google Ventures) along with Main Street Advisors, Visionary Ventures, and YK Bioventures. The firm plans to begin Phase 3 trials in 2026, with broader cohorts including women and long-term balding cases.
PP405 vs. Conventional Treatments
| Feature | PP405 | Minoxidil / Finasteride |
| Mechanism | Metabolic reactivation of follicle stem cells | Vasodilation (minoxidil); DHT-blocking (finasteride) |
| Time to visible effect | ~8 weeks for some participants | 6-12 months on average |
| Systemic absorption | None detected | Finasteride can cause systemic hormonal side effects |
| Gender suitability | Non-hormonal; potentially effective for all | Finasteride not approved for women; limited for some |
| Efficacy in bald zones | Yes, new hair growth observed | Generally limited to thickening existing hair |
Today's gold-standard drugs predominantly manage symptoms and stabilise hair loss. PP405 is potentially the first topical drug designed to reactivate dormant follicles and regenerate hair.
BioScalp Product Support & Links
While PP405 remains in clinical development, maintaining optimal scalp health is crucial, especially for early thinning. In Australia, the BioScalp DHTI Control line, available through Scalp Solution, offers botanical support that may complement future therapies:
A 3-step system combining a scalp cleanser, DHTI Control Shampoo, and advanced scalp tonic. It features Capixyl™ (tetrapeptide‑3 + red clover extract) along with botanical DHT inhibitors, amino acids, and antioxidants to reduce DHT-related stress, detoxify the scalp, and reinforce follicle strength.
A standalone option with salicylic acid exfoliation, provitamin B5, and Capixyl™, this shampoo is formulated to support reduced oil, blocked scalp DHT, and improved hair anchoring, ideal for early androgenetic thinning.
⚠️ While PP405 isn’t commercially available yet, establishing a clean, nutrient-rich scalp foundation may enhance the effectiveness of future treatments that aim to reactivate follicles.
What Comes Next?
- Responder variation: Only ~31% of men in advanced stages responded in Phase 2a. Results in women and earlier-stage cases are still pending, with subgroup analyses expected in emerging data.
- Durability questions: The study involved just 4 weeks of PP405 application. The longevity of regrowth post-treatment and whether maintenance dosing is needed remains unknown.
- Safety over time: While short-term data indicate a clean safety profile, longer-term tolerability and usability across diverse populations require Phase 3 validation.
- Regulatory timeline: Assuming all goes well, PP405 could enter regulatory review after Phase 3, which is targeted for 2026, suggesting possible market approval no earlier than 2027–28.
Why PP405 Is a Landmark
Hair loss affects more than 80% of men and 40% of women during their lifetimes, often causing emotional distress amplified by social media and beauty culture. Current FDA‑approved therapies (topical minoxidil and oral finasteride) benefit only a subset and often carry side‑effect risks.
PP405 may represent the first hormone‑free, follicle-targeted topical therapy that can:
- Deliver visible results in weeks instead of months
- Stimulate growth in previously dormant follicles
- Be safely used across genders (pending further data)
If Phase 3 and regulatory review succeed, PP405 could mark a new chapter in regenerative dermatology and hair health.
Conclusion
PP405 has demonstrated early signs of real hair regeneration, not merely slowing loss. Its Phase 2a success, rapid onset, and safety profile signal it may become the first topical drug to truly activate dormant follicles.
In anticipation of future access to PP405, BioScalp formulations offer groundwork support by maintaining scalp health, reducing DHT influence, and strengthening follicles.
Keep an eye on Pelage’s Phase 3 trial in 2026, but for now, PP405 stands as the most scientifically grounded, non‑hormonal, regenerative hair loss solution in the pipeline.
References
www.dermatologytimes.com/view/new-topical-agent-for-alopecia-to-enter-phase-2-trials
www.washingtonpost.com/health/2025/08/03/male-pattern-baldness-treatments-anxiety/
nypost.com/2025/03/27/lifestyle/men-going-bald-turn-to-new-botox-for-hair-loss-treatment/
