Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Study Phase : Phase II
Sponsor : HighTide Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
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).
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Undisclosed
December 15, 2022
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Sponsor : HighTide Therapeutics
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Study Phase : Phase II
Sponsor : TCM Healthcare
Deal Size : $107.0 million
Deal Type : Series C Financing
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.
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Undisclosed
January 05, 2023
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Sponsor : TCM Healthcare
Deal Size : $107.0 million
Deal Type : Series C Financing
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
HighTide Therapeutics Announces Presentations at The Liver Meeting® 2022
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.
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 25, 2022
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 clin...
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 30, 2022
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 29, 2022
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Endocrinology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : U.S. Food and Drug Administration
Deal Size : Undisclosed
Deal Type : Agreement
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.
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 22, 2022
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : U.S. Food and Drug Administration
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : U.S. Food and Drug Administration
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 22, 2022
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : U.S. Food and Drug Administration
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
HighTide Therapeutics to Present New PSC and NASH Clinical Data at AASLD 2021
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.
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 28, 2021
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : HTD1801
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 15, 2020
Lead Product(s) : Berberine Ursodeoxycholate
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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