The PSC HTD1801 clinical study is for adults between 18-75 years of age who have been diagnosed with Primary Sclerosing Cholangitis for 6 months or more. The purpose of this study is to understand how well a twice a day oral medication (taken by mouth), berberine ursodeoxycholate, referred to as HTD1801, treats PSC.
HTD1801, berberine ursodeoxycholate, is an oral investigational drug developed by HighTide to treat Primary Sclerosing Cholangitis. The Food and Drug Administration (FDA) granted HighTide “Fast Track” designation for HTD1801 in the treatment of PSC, in recognition that HTD1801 has the potential to address an unmet medical need based on data shared with the FDA. To our knowledge, HTD1801 is the only drug to receive fast track designation for PSC.
Berberine ursodeoxycholate is a salt containing two active ingredients, combined in a 1 to 1 ratio into a tablet. Thus, these two active ingredients have been combined into one new, single drug. One of the 2 main ingredients in HTD1801 is UDCA, which is already approved by the Food and Drug Administration (FDA) as a prescription drug to treat patients with primary biliary cholangitis (PBC). The other main ingredient is berberine, an over the counter drug approved in Japan, Taiwan, and China for treating GI disorders. Berberine is also available as an ingredient in dietary supplements sold in the US, however, patients should be aware that dietary supplements are not regulated the way drugs are in terms of content and quality.
Laboratory and animal data obtained by HighTide indicate that the berberine ursodeoxycholate salt yields results that are clearly superior to a simple mixture of berberine and UDCA. The specific properties of the salt provide the support for HighTide’s belief that a significant new treatment is being developed for patients with PSC.
An investigational new drug is one that the Food and Drug Administration (FDA) has provided permission for the Sponsor, in this case, HighTide, to test in humans for a specific condition. Testing in human participants must be completed and the results provided to the FDA or other regulatory agency for them to determine whether the drug is safe and effective for the condition for which it is being developed. The FDA or other regulatory agency in other countries may approve the drug and your doctor may prescribe it for you.