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    [{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"HTD1801","moa":"Lipid","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II","graph3":"HighTide Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Tablet","sponsorNew":"HighTide Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"HighTide Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","country":"","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Berberine 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    Find Clinical Drug Pipeline Developments & Deals by HighTide Therapeutics

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                            01

                            HighTide Therapeutics

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                            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

                            DEALS_DEV arrow-down

                            HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business...

                            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

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                            02

                            HighTide Therapeutics

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                            Lead Product(s) : Berberine Ursodeoxycholate

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase II

                            Recipient : Quotient Sciences

                            Deal Size : Undisclosed

                            Deal Type : Agreement

                            DEALS_DEV arrow-down

                            HighTide Therapeutics and Quotient Sciences Announce Agreement to Conduct a 14C Human ADME Program for HTD1801

                            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

                            Recipient : Quotient Sciences

                            Deal Size : Undisclosed

                            Deal Type : Agreement

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                            03

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                            Lead Product(s) : Berberine Ursodeoxycholate

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            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

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                            04

                            HighTide Therapeutics

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                            Lead Product(s) : Berberine Ursodeoxycholate

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            HighTide Therapeutics Announces Early Completion of Enrollment in Phase 2 Clinical Study Evaluating HTD1801 in...

                            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

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                            05

                            HighTide Therapeutics

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                            Lead Product(s) : Berberine Ursodeoxycholate

                            Therapeutic Area : Endocrinology

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            HighTide Therapeutics Announces First Patient Dosed in Phase 2 Clinical Study Evaluating HTD1801 in Type 2 Dia...

                            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

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                            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

                            DEALS_DEV arrow-down

                            HighTide Therapeutics Announces End-of-Phase 2 Meeting with FDA and Agreement to Proceed to Phase 3 for HTD180...

                            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

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                            07

                            HighTide Therapeutics

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                            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

                            DEALS_DEV arrow-down

                            HighTide Therapeutics Announces End-of-Phase 2 Meeting with FDA and Agreement to Proceed to Phase 3 for HTD180...

                            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

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                            08

                            HighTide Therapeutics

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                            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

                            DEALS_DEV arrow-down

                            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

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                            09

                            HighTide Therapeutics

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                            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

                            DEALS_DEV arrow-down

                            HighTide Therapeutics to Present Phase 2 Results of HTD1801 in NASH Patients Co-Morbid with Type 2 Diabetes at...

                            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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                            10

                            HighTide Therapeutics

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                            Lead Product(s) : HTD1801

                            Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

                            Study Phase : Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            HighTide Therapeutics Announces Positive Topline Results From Phase 2a Study of HTD1801 in NASH Patients

                            Details : HTD1801 met primary endpoint in Phase 2 trial with statistically significant reduction in liver fat in patients with NASH and diabetes.

                            Brand Name : Undisclosed

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            May 07, 2020

                            Lead Product(s) : HTD1801

                            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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