Chinese biotechnology company XtalPi has advanced its proprietary hair loss drug programme into IND-enabling studies, expanding its work in hair health from cosmetic ingredients into drug development.
According to the company, pharmacology, safety and chemistry, manufacturing and controls (CMC) studies are now underway to support a future Investigational New Drug (IND) application.
XtalPi’s hair loss programme targets a novel pathway to reactivate quiescent hair follicle stem cells
Androgenetic alopecia, commonly known as pattern hair loss, affects both men and women and often requires long-term management. Global Market Insights estimates that the global androgenetic alopecia treatment market will be worth USD 3.4 billion in 2026 and projects it to reach USD 6.8 billion by 2035.
Topical minoxidil and oral finasteride remain widely used treatments for pattern hair loss. However, responses vary between patients and treatment generally needs to be continued to maintain benefits. Topical minoxidil can also cause scalp irritation, while oral finasteride carries labelled risks of sexual adverse effects. These limitations have driven interest in treatments that target the underlying biology of hair follicle regeneration.
Targeting hair follicle stem-cell activation
XtalPi’s drug programme focuses on the metabolic and cellular processes that regulate hair follicle stem-cell activation. The company said preliminary studies indicate that its candidate acts through a lactate–autophagy pathway to reactivate quiescent hair follicle stem cells.
“By restoring cellular autophagy, the essential process by which cells recycle damaged components to maintain function, the candidate reactivates dormant stem cells to support renewed hair growth,” XtalPi explained.
Cell-based assays also showed increased lactate production, providing further support for investigating the candidate’s potential role in sustained hair regrowth.
In a dihydrotestosterone (DHT)-induced mouse model of androgenetic alopecia, XtalPi said the candidate produced a hair-growth score comparable to that of 5% topical minoxidil at one-hundredth of the comparator’s concentration.
The company also reported preliminary evidence of reduced local follicular inflammation. These findings are being used to guide further evaluation of a low-concentration topical formulation and its effects on the follicular environment.
AI and robotics used in candidate optimisation
XtalPi said it used an iterative drug-discovery workflow combining AI-guided molecular design, physics-based free-energy perturbation (FEP) calculations, and robotic synthesis and testing.
The approach was used to optimise the candidate for target potency and selectivity, while also assessing skin penetration, safety and developability for topical delivery.
The company has already commercialised two AI-developed proprietary ingredients for topical scalp care: Remeanagen, a small molecule, and AquaKine, a peptide. Both have received International Nomenclature of Cosmetic Ingredients (INCI) names.
Groland, a consumer brand incubated by XtalPi, has completed US cosmetic facility registration and product listing for a formulation combining the two ingredients. Groland products are now commercially available.
XtalPi said its experience in scalp-care research and formulation has provided a foundation for advancing redesigned and optimised candidates into drug development.
The current programme is evaluating mechanism of action, dose–response relationships, pharmacokinetics, safety margins and suitability for long-term treatment as the company works towards the requirements for a prescription medicine.
