Expanded Access Policy
We are currently focused on developing berberine ursodeoxycholate (HTD1801) to treat type 2 diabetes mellitus (T2DM), metabolic dysfunction-associated steatohepatitis (MASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). This involves clinical trials to evaluate the safety and effectiveness of HTD1801. If these trials demonstrate that HTD1801 is safe and effective for treating these diseases, we will then pursue marketing approvals from regulatory health authorities to make our compound available to patients.
We understand that some patients with serious or life-threatening conditions might not be eligible for our clinical trials and may seek access to investigational therapy outside of a trial setting. This process is known as expanded access, treatment use, or compassionate use. At this time, we are not offering any of our investigational therapies through expanded access programs. However, we will assess and address expanded access requests individually, considering each case separately. This policy may change as laws and regulations evolve.
If you are interested in learning more about HTD1801 or any of our investigational therapies, or enrolling in our ongoing studies, visit clinicaltrials.gov and search for HighTide Therapeutics. Physicians interested in our investigational therapies or joining our trials can contact us at clinical@hightidetx.com.