HighTide Therapeutics integrates expertise in disease biology, medicinal chemistry, clinical development, and regulatory affairs to develop novel therapeutics for the global markets. Several clinical trials have been completed in the United States, Australia, Canada and China.

Currently, HighTide is focusing on advancing the development of several assets. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity. HighTide’s continued clinical progress with HTD1801 includes a global Phase 2b study that has been initiated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), an initiate Phase 3 study for the treatment of type 2 diabetes (T2DM), and the successful end-of-phase 2 clinical studies for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). The U.S. Food and Drug Administration (FDA) has granted HTD1801 Fast Track designation in both MASH and PSC.

Our Pipeline

Product Proposed Indications Discovery Preclinical Phase 1 Phase 2 Phase 3
HTD1801 Metabolic Dysfunction-associated Steatohepatitis (MASH)
Type 2 Diabetes (T2DM)
Severe Hypertriglyceridemia (SHTG)
Primary Sclerosing Cholangitis (PSC)
HTD4010 Alcoholic Hepatitis (AH)
HTD2802 Inflammatory Bowel Disease (IBD)
HTD1804 Diabetic Complications
HTD1805 Diabetic Complications
HTD1807 Metabolic; Chronic Liver; CNS


Updated on June 2021

1.Develop in China only, while other indications are developed by IMCT (International Multicenter Clinical Trial)


New molecular entity: ionic salt of two active moieties

Metabolic Dysfunction-associated Steatohepatitis (MASH)
MASH is a form of NAFLD in which you have hepatitis—inflammation of the liver—and liver cell damage, in addition to fat in your liver.
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Type 2 Diabetes (T2DM)
Type 2 diabetes mellitus (T2DM), accounts for more than 90% of diabetes and is largely the result of excess body weight and physical inactivity.
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Severe Hypertriglyceridemia (SHTG)
Hypertriglyceridemia (HTG) is a common form of a lipid disorder with a fasting plasma triglyceride (TG) above 150 mg/dL. Patients with severe hypertriglyceridemia (SHTG) have triglyceride levels more than three times the normal level, i.e. >500 mg/dL.
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Primary Sclerosing Cholangitis (PSC)
Chronic liver disease characterized by a progressive reduction or stoppage of bile flow with inflammation and fibrosis of the intrahepatic and extrahepatic bile ducts.
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Peptide analog of RegIII/PAP protein active fragment

Alcoholic Hepatitis (AH)
Alcoholic hepatitis (AH) is an acute, life-threatening disease caused by chronic heavy alcohol use or a drastic increase in alcohol consumption.
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An innovative fixed dose combination of two known compounds with clear differentiation for unmet clinical needs

Inflammatory Bowel Disease (IBD)
Inflammatory bowel disease (IBD) is a general term used to describe disorders that involve chronic inflammation of the digestive tract.
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