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HTD1801 (HighTide Therapeutics, Inc.)
- Development stage
- Unknown
- Lead developer
- HighTide Therapeutics
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
HTD1801 is a first-in-class new molecular entity (NME) developed by HighTide Biopharma, consisting of an ionic salt of berberine and ursodeoxycholic acid (UDCA). This bifunctional compound is designed to address the complex pathophysiology of metabolic and chronic liver diseases by providing synergistic effects. The berberine component acts as an activator of AMP-activated protein kinase (AMPK) and reduces the expression of PCSK9, thereby improving glucose and lipid metabolism. The UDCA component is a hydrophilic bile acid that provides cytoprotective effects, modulates the bile acid pool, and interacts with bile acid receptors such as FXR and GPBAR1. HTD1801 has received Fast Track and Orphan Drug designations from the FDA for the treatment of primary sclerosing cholangitis (PSC) and is also being evaluated for metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes.
- Other names
- berberine ursodeoxycholateberberine ursodeoxycholic acid saltB-UDCA
02
Targets
AMPK (Adenosine monophosphate–activated protein kinase)FXR (Farnesoid x-activated receptor)GPBAR1LDLR (Low-density lipoprotein receptor)NLRP3 (Nod-like receptor family pyrin domain-containing protein 3)PCSK9 (Proprotein convertase subtilisin/kexin type 9)
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