A phase 3 trial of HTD 1801 in the patients with Primary-sclerosing-cholangitis

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 24 Feb 2022

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At a glance

24 Feb 2022 New trial record
22 Feb 2022 According to a HighTide Biopharma media release, company and U.S. Food and Drug Administration (FDA) reached agreement to proceed to Phase 3 development of HTD1801 for the treatment of primary sclerosing cholangitis (PSC). The company had a productive discussion with FDA as part of an End-of-Phase 2 meeting, regarding the key elements of the study design and will be submitting a Phase 3 protocol to FDA for review and comment.

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