HighTide’s dual-action diabetes drug passes phase 3 trials in China

CHINA – HighTide Therapeutics, a clinical-stage biopharma company, has announced positive results from two Phase 3 trials in China for its novel drug HTD1801, aimed at treating type 2 diabetes (T2DM).

The trials—SYMPHONY 1 and SYMPHONY 2—tested HTD1801 (berberine ursodeoxycholate) on over 950 adult patients with T2DM.

The goal was to assess how well the drug lowered blood sugar levels, especially in those not seeing improvement from diet, exercise, or Metformin alone. Results showed that HTD1801 not only met but exceeded its main targets.

In SYMPHONY 1, which tested HTD1801 as a standalone therapy, patients saw an average drop of 1.3% in HbA1c—a key marker for blood sugar control—after 24 weeks.

Those with more severe diabetes (HbA1c ≥8.5%) saw even better results, with a 1.5% reduction.

In SYMPHONY 2, where HTD1801 was added to Metformin treatment, patients experienced a 1.2% HbA1c reduction.

Furthermore, people with more advanced cases had even greater improvements, dropping HbA1c by 1.6%.

The drug didn’t just lower blood sugar. It also improved other health markers like fasting plasma glucose, bad cholesterol (LDL-C and non-HDL-C), and inflammatory proteins (GGT and hs-CRP), all of which are tied to heart and metabolic health.

According to Dr. Linong Ji, the lead investigator and an expert in endocrinology, HTD1801 could mark a big step forward in T2DM treatment.

“HTD1801 has a unique dual mechanism—activating AMP kinase and blocking NLRP3 inflammasomes,” he said.

“This could help tackle not just blood sugar but also inflammation and poor lipid metabolism, offering patients a broader range of benefits.”

HighTide also confirmed that HTD1801 was safe and well-tolerated. Fewer than 2% of patients dropped out due to side effects, mostly mild digestive issues. Importantly, there were no cases of severe low blood sugar (hypoglycemia).

Given the strong trial outcomes, HighTide plans to file a New Drug Application (NDA) with the National Medical Products Administration (NMPA) in China later this year. If approved, HTD1801 could become a new option for millions of people living with diabetes in China and beyond.

Dr. Liping Liu, HighTide’s founder and CEO, highlighted the company’s mission to innovate in the diabetes space.

“With this dual-action therapy, we aim to offer a more complete solution for people with chronic metabolic diseases,” she said.

Type 2 diabetes continues to affect millions globally. In China alone, more than 140 million people live with diabetes—a number expected to grow to 174 million by 2045.