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Details:
HTD1801 (berberine ursodeoxycholate), is a first-in-class new molecular entity, currently in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH).
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Endocrinology Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: HighTide Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 15, 2022
Details:
HighTide's lead candidate HTD1801 (berberine ursodeoxycholate), is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Endocrinology Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: TCM Healthcare
Deal Size: $107.0 million Upfront Cash: Undisclosed
Deal Type: Series C Financing January 05, 2023
Details:
The data showing positive changes in gut microbiota are encouraging and provide another mechanism of action underlying the beneficial effects of HTD1801 (Berberine Ursodeoxycholate) in liver and metabolic diseases.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Endocrinology Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2022
Details:
The unique design of HTD1801 (berberine ursodeoxycholate) results in its pleiotropic therapeutic effects. Previous Phase 2 study in adults with comorbid nonalcoholic steatohepatitis (NASH) and T2DM completed in the United States demonstrated overall clinical benefits.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Endocrinology Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2022
Details:
HTD1801 is a first-in-class new molecular entity with pleiotropic effects, designed to target both the metabolic pathways critical to the development of T2DM and pathogenic factors underlying liver dysfunction and the progression of NAFLD.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Endocrinology Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2022
Details:
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 of HTD1801 in patients with PSC and will be submitting a Phase 3 protocol to FDA for review and comment.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Food and Drug Administration
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 22, 2022
Details:
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 of HTD1801 in patients with PSC and will be submitting a Phase 3 protocol to FDA for review and comment.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Food and Drug Administration
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Details:
An orally active ionic salt of berberine and ursodeoxycholic acid in development for chronic liver diseases, HTD1801 is currently being evaluated in Phase 2 trials in PSC, NASH and PBC.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2021
Details:
HighTide will show the results of their Phase 2 study of HTD1801 in adults with NASH and type 2 diabetes mellitus. HTD1801 met primary endpoint in Phase 2 trial with statistically significant reduction in liver fat in patients with NASH and diabetes.
Lead Product(s): Berberine Ursodeoxycholate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: HTD1801
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
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