Huadong Medicine's DR10624 Gets Heart Failure Phase II Approval; Cuts Triglycerides 75%, Liver Fat 67%

DR10624 has been selected for a national major science and technology project. Daoer Biologics will conduct a Phase II clinical study of DR10624 in heart failure under the project titled "Clinical Research of Innovative Drugs for Heart Failure with Energy Metabolism Disorders". The drug is a first-in-class long-acting triple agonist that simultaneously targets the FGF21 receptor, glucagon receptor, and GLP-1 receptor.

In January 2026, DR10624 was designated as a breakthrough therapy for severe hypertriglyceridemia. In July 2026, the drug received approval from China's National Medical Products Administration to conduct clinical trials in patients with heart failure with preserved or mildly reduced ejection fraction. In June of the same year, the first patient was enrolled in its Phase III pivotal clinical study for the SHTG indication. Another Phase II clinical study for metabolic dysfunction-associated steatotic liver disease completed enrollment of all subjects in January 2026.

Clinical trial applications for DR10624 in type 2 diabetes, weight management in overweight or obese individuals, and hypertriglyceridemia have been approved. Additionally, U. S. clinical trial applications for the SHTG and metabolic dysfunction-associated steatotic liver disease indications have also been approved. Phase II data, presented at the 2025 American Heart Association Scientific Sessions, showed that DR10624 reduced triglyceride levels by up to 75% and decreased liver fat by 67%. The Phase II clinical study for the heart failure indication has been initiated, marking the drug's entry into parallel development across metabolic and cardiovascular disease areas.