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berberine ursodeoxycholate (HighTide Therapeutics, Inc.)
- Development stage
- Unknown
- Lead developer
- HighTide Therapeutics
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
HTD1801 (berberine ursodeoxycholate) is a first-in-class new molecular entity (NME) developed by HighTide Biopharma. It is an ionic salt combination of berberine and ursodeoxycholic acid (UDCA), designed to provide additive and synergistic effects in treating metabolic and chronic liver diseases. The drug targets multiple pathways: berberine acts as an AMPK activator and PCSK9 inhibitor to improve lipid metabolism and insulin sensitivity, while UDCA provides hepatoprotective and choleretic effects through modulation of bile acid receptors like FXR and TGR5. HTD1801 is primarily being developed for non-alcoholic steatohepatitis (NASH) with comorbid type 2 diabetes or pre-diabetes, and has also received Fast Track and Orphan Drug designations for primary sclerosing cholangitis (PSC).
- Other names
- HTD-1801HTD1801HTD 1801berberine ursodeoxycholate saltBBR-UDCA
02
Targets
AMPK (Adenosine monophosphate–activated protein kinase)FXR (Farnesoid x-activated receptor)NLRP3 (Nod-like receptor family pyrin domain-containing protein 3)PCSK9 (Proprotein convertase subtilisin/kexin type 9)GPBAR1
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