Drug intelligence / Profile preview

berberine ursodeoxycholate

Development stage
Phase 3
Lead developer
HighTide Therapeutics
Modality
Small Molecules
Administration
Oral
01

Overview

Berberine ursodeoxycholate is an investigational, orally administered **single molecular entity** developed by HighTide Therapeutics as a gut-liver anti-inflammatory metabolic modulator. Also known as HTD1801 or BUDCA, it is a 1:1 ionic salt of berberine and ursodeoxycholic acid that is intended to dissociate in the gastrointestinal tract. The compound is reported to activate AMP-activated protein kinase and inhibit the NLRP3 inflammasome, supporting effects on insulin resistance, glucose and lipid metabolism, hepatic injury, and inflammation. It has completed Phase 3 studies in type 2 diabetes mellitus, and China’s National Medical Products Administration accepted its new drug application for type 2 diabetes mellitus in March 2026. Additional clinical development has included metabolic dysfunction-associated steatohepatitis, cholestatic liver diseases, chronic kidney disease, and hypercholesterolemia. ([hightidetx.com](https://www.hightidetx.com/blog/2026/03/10/hightide-therapeutics-announces-acceptance-of-new-drug-application-for-htd1801-by-chinas-national-medical-products-administration/))

Brand names
HTD1801HTD-1801HTD 1801
Other names
BUDCA
02

Targets

AMPK (Adenosine monophosphate–activated protein kinase)NLRP3 (Nod-like receptor family pyrin domain-containing protein 3)

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