Berberine Ursodeoxycholate (HTD1801) Consistently Demonstrates Comprehensive Benefits for Patients with Type 2 Diabetes Mellitus, Approaching NDA

In Hong Kong on April 15, 2025, HighTide Therapeutics, Inc. (2511.HK), a biopharmaceutical company focused on developing therapies for chronic liver and metabolic diseases, revealed that two Phase 3 trials (SYMPHONY 1 and SYMPHONY 2) of berberine ursodeoxycholate (HTD1801) in Chinese patients with type 2 diabetes mellitus (T2DM) successfully achieved their primary goals and additional objectives.

The outcomes of these Phase 3 clinical trials offer strong evidence that HTD1801 provides significant benefits for individuals with T2DM. With these encouraging results, HighTide intends to present a new drug application (NDA) for HTD1801 as a T2DM treatment to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) later this year.

SYMPHONY 1 (NCT06350890) and SYMPHONY 2 (NCT06353347) are Phase 3 clinical trials that are randomized, double-blind, and placebo-controlled. Their purpose is to assess the effectiveness and safety of HTD1801 in adults with T2DM who have insufficient glycemic control despite diet and exercise (SYMPHONY 1; N=407) or Metformin use (SYMPHONY 2; N=549). The main objective in both trials was to measure the change in HbA1c from baseline with HTD1801 compared to placebo after 24 weeks of treatment. Additional objectives included the percentage of participants achieving HbA1c levels.