China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
BioWorld tracked 215 clinical trial readouts spanning phases I through III in December 2025, a sizeable increase from 170 updates in November, but below the 252 reported in October.
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met primary and secondary endpoints in the Symphony 1 and Symphony 2 phase III trials in type 2 diabetes in Chinese patients. Based on the data, Shenzhen-based Hightide will submit an NDA to China’s National Medical Products Administration (NMPA) later this year.
Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes.
Hightide Therapeutics Inc. closed a $107 million series C round that will advance multiple global development programs for lead candidate HTD-1801, including a phase III trial in type 2 diabetes.
Hightide Therapeutics Inc. presented top-line results of its lead program, HTD-1801, from a multicenter phase II trial in primary sclerosing cholangitis (PSC), which showed the drug candidate reduced alkaline phosphatase levels compared to placebo.
Two companies, Hightide Therapeutics Inc. and Axcella Health Inc., posted positive data from recent liver disease studies while Enanta Pharmaceuticals Inc. missed its phase II liver study’s primary endpoint.
BEIJING – Hightide Therapeutics Inc., of Shenzhen, China, and Rockville, Md., said it finished the enrollment in phase IIa trials for its lead asset, HTD-1801, which is a potential first-in-class new molecular entity for primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH).
