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Recently, ZMUni Compliance Centre successfully supported XtalPi Holdings Limited (2228.HK) in securing a U.S. Self-affirmed GRAS determination for Tensotide™, an innovative oral peptide ingredient designed for blood glucose management. Developed through XtalPi's proprietary AI-powered peptide platform PepiX™, Tensotide™ is now cleared for lawful use in foods and dietary supplements in the United States, enabling a significant step forward in its global commercialization pathway.
This milestone represents another key achievement for XtalPi in the consumer health space and highlights ZMUni Compliance Centre's strong capabilities in overseas food regulatory compliance and international market access for novel and innovative ingredients, consistently enabling science-driven innovations to reach global markets.
With rising global prevalence of obesity and hyperglycemia, metabolic health continues to be a key growth area in the food and dietary supplement sector.
Current solutions remain limited by a trade-off between efficacy, safety, and cost. GLP-1 therapies require injection and long-term safety considerations, while botanical extracts and conventional peptides often face challenges in mechanism standardization and oral stability.
Tensotide™ was developed to address these gaps, offering a combination of demonstrated efficacy, strong stability, safety profile, and scalable production, supporting its use in food and supplement applications. In preclinical studies, it showed a reduction in post-meal blood glucose peaks of up to 30%.
The ingredient also demonstrates robust stability under heat, extreme pH, and enzymatic conditions, overcoming a key limitation in oral functional peptide development. To date, it has obtained a granted Chinese invention patent, completed PCT international filing, and achieved kilogram-scale production validation, supporting its readiness for industrial application.
With its regulatory status, functional profile, and formulation flexibility, Tensotide™ is well positioned for applications across dietary supplements and everyday food formats, supporting broader low-GI dietary solutions.
Regulatory statement: Tensotide™ is a food-grade ingredient compliant with applicable regulations. The information provided herein does not constitute any claim of therapeutic, disease-preventing, or health-promoting effects.
XtalPi Holdings Limited (XTALPI, 2228.HK), founded in 2015 by three MIT physicists, is an innovative R&D platform powered by quantum physics, artificial intelligence, and robotics.
The company integrates first-principles quantum physics-based computation, AI algorithms, high-performance cloud computing, and scalable robotic automation to deliver end-to-end R&D solutions for pharmaceutical and material science industries, including agriculture technology, energy, novel chemicals, and cosmetics.
ZMUni Compliance Centre provides end-to-end global regulatory compliance solutions for cosmetics, food, and ingredient companies, supporting international market access across key regulatory jurisdictions.
Our Food Division covers the full compliance pathway, including ingredient regulatory compliance (novel foods, food additives, feed ingredients), product compliance (food products, health foods, and FSMP registrations), and import/export regulatory support.
With over 10 years of experience, the team has supported global market entry projects across novel foods, synthetic biology-derived ingredients, U.S. GRAS self-affirmation, EU Novel Food applications, and functional health food registrations. For inquiries, contact info@zmuni.com.
