XtalPi Advances Hair Loss Drug Program into IND-Enabling Studies

• The proprietary program targets a lactate–autophagy pathway to reactivate quiescent hair follicle stem cells.
• In a mouse model, a candidate achieved a hair-growth score comparable to that of 5% topical minoxidil at just 1/100 of the comparator's concentration.
• The milestone builds on the commercialization success of two AI-developed scalp-care ingredients and extends XtalPi's work in hair health into drug development.

CAMBRIDGE, Mass. and SHENZHEN, China, Oct. 2, 2026 /PRNewswire/ -- XtalPi (HKEX: 2228), an AI and robotics company focused on drug and materials discovery, today announced that its proprietary hair loss drug program has entered IND-enabling studies. Pharmacology, safety and chemistry, manufacturing and controls (CMC) studies are underway to support a future Investigational New Drug (IND) application.

Androgenetic alopecia, commonly known as pattern hair loss, affects both men and women and can require long-term management. Global Market Insights estimates the global androgenetic alopecia treatment market at US$3.4 billion in 2026 and projects it will reach US$6.8 billion by 2035.

Topical minoxidil and oral finasteride remain the primary standards of care for pattern hair loss. While effective for some patients, responses vary and continuous application is required to maintain benefits. In addition, topical minoxidil often causes scalp irritation, while oral finasteride carries labeled risks of sexual adverse effects, underscoring the need for novel mechanisms that directly reactivate quiescent hair follicle stem cells.

XtalPi's program focuses on the metabolic and cellular processes that regulate hair follicle stem-cell activation. Preliminary data indicate that its candidate acts through a lactate–autophagy pathway. 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. Cell-based assays also demonstrated increased lactate production, supporting further investigation of the candidate's effects on sustained hair regrowth.

In a DHT-induced mouse model of androgenetic alopecia, a candidate achieved a hair-growth score comparable to that of 5% topical minoxidil at just one-hundredth of the comparator's concentration. Additional preclinical observations suggest potential activity in reducing local follicular inflammation. These findings support further evaluation of low-concentration topical treatment, including its effects on the follicular environment.

To achieve this differentiated profile, XtalPi applied an iterative workflow combining AI-guided molecular design, physics-based free-energy perturbation (FEP) calculations, and robotic synthesis and testing. This integrated platform approach enabled the team to systematically optimize target potency and selectivity alongside skin penetration, safety, and developability for topical delivery.

XtalPi has already commercialized 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 U.S. cosmetic facility registration and product listing for a formulation combining the ingredients. Groland products are now commercially available, and its scalp serum previously ranked No. 1 on Tmall's new-product chart for anti-hair-loss scalp serums.

Building on this research and formulation experience, XtalPi has redesigned and optimized candidates for drug development. The team is evaluating mechanism of action, dose–response relationships, pharmacokinetics, safety margins and suitability for long-term treatment to meet the requirements of a prescription medicine.

The program follows recent progress across XtalPi's internally developed and partner pipelines, including a U.S. IND submission for a gut-restricted treatment for chronic intestinal pain and the nomination of an HIV preclinical candidate. These programs demonstrate the application of its AI and robotics infrastructure across distinct therapeutic areas, supporting candidate discovery and optimization as proprietary and partnered assets advance toward clinical development.

About XtalPi

XtalPi Holdings Limited (XtalPi, 2228.HK) was founded in 2015 by three physicists from the Massachusetts Institute of Technology (MIT). It is an innovative R&D platform powered by quantum physics, artificial intelligence, and robotics. By integrating first-principles calculations, AI algorithms, high-performance cloud computing, and standardized automation systems, XtalPi provides digital and intelligent R&D solutions for companies in the pharmaceutical, materials science, agricultural technology, energy, new chemicals, and cosmetics industries.

SOURCE XtalPi Inc.