熊去氧胆小檗碱(HTD1801)是一种靶向肠-肝系统的口服抗炎及代谢调节剂，正在开发用于治疗代谢及消化系统疾病。HTD1801为熊去氧胆酸和小檗碱的离子盐，是一种具有独特双机制的新分子实体，通过激活AMPK及抑制NLRP3发挥其生物学活性。这两种关键机制与改善葡萄糖代谢、胰岛素抵抗、脂质代谢和肝臟炎症相关，为T2DM等复杂代谢性疾病的治疗提供综合性解决方案。HIGHTIDE-B (02511) announced that the company's independently developed intestinal and hepatic anti-inflammatory and metabolic regulator ursodeoxycholic acid...
According to the Zhito Finance APP, HIGHTIDE-B (02511) announced that the Phase III clinical trial of its self-developed intestinal and hepatic anti-inflammatory and metabolic regulator, ursodeoxycholic acid and berberine (HTD1801), targeting patients with type 2 diabetes (T2DM), has completed patient enrollment.
This trial is a randomized, double-blind, positive drug (Dapagliflozin) parallel-controlled, multicenter, non-inferiority Phase III clinical trial (HARMONY), aimed at assessing the efficacy of HTD1801 compared to Dapagliflozin in adult T2DM subjects with poor blood sugar control after metformin treatment, with the primary efficacy endpoint being the change in glycated hemoglobin relative to baseline after 24 weeks of treatment. A total of 358 subjects are planned for enrollment, and enrollment has now been completed. This Phase III trial is expected to report data in 2025.
Ursodeoxycholic acid and berberine (HTD1801) is an oral anti-inflammatory and metabolic regulator targeting the intestinal-hepatic system, being developed for the treatment of metabolic and digestive system diseases. HTD1801 is an ionic salt of ursodeoxycholic acid and berberine, representing a new molecular entity with a unique dual mechanism, exerting its biological activity by activating AMPK and inhibiting NLRP3. These two key mechanisms are associated with improvements in glucose metabolism, insulin resistance, lipid metabolism, and hepatic inflammation, providing a comprehensive solution for the treatment of complex metabolic diseases such as T2DM.
