[{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics to Present Phase 2 Results of HTD1801 in NASH Patients Co-Morbid with Type 2 Diabetes at NASH Summit","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","year":"2020","type":"Not Applicable","leadProduct":"Berberine Ursodeoxycholate","moa":"Lipid","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II","graph3":"HighTide Therapeutics","amount2":0,"therapeuticAreaNew":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Hepatology","productSubType":"Small 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Bladder)","graph2":"Phase II","graph3":"HighTide Therapeutics","amount2":0,"therapeuticAreaNew":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Hepatology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Pressurised Metered-dose Inhaler","sponsorNew":"HighTide Therapeutics \/ U.S. Food and Drug Administration","highestDevelopmentStatusID":"8","companyTruncated":"HighTide Therapeutics \/ U.S. Food and Drug Administration"},{"orgOrder":0,"company":"HighTide Therapeutics","sponsor":"U.S. Food and Drug Administration","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics Announces End-of-Phase 2 Meeting with FDA and Agreement to Proceed to Phase 3 for HTD1801 for the Treatment of PSC","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase 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Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"HighTide Therapeutics Announces Presentations at The Liver Meeting\u00ae 2022","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","year":"2022","type":"Not Applicable","leadProduct":"Berberine Ursodeoxycholate","moa":"","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II","graph3":"HighTide Therapeutics","amount2":0,"therapeuticAreaNew":"Endocrinology","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Endocrinology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"HighTide Therapeutics \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"HighTide Therapeutics \/ Not Applicable"},{"orgOrder":0,"company":"Quotient Sciences","sponsor":"HighTide Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"HighTide Therapeutics and Quotient Sciences Announce Agreement to Conduct a 14C Human ADME Program for HTD1801","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","year":"2022","type":"Agreement","leadProduct":"Berberine Ursodeoxycholate","moa":"","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II","graph3":"Quotient Sciences","amount2":0,"therapeuticAreaNew":"Endocrinology","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Endocrinology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Quotient Sciences \/ HighTide 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Find Clinical Drug Pipeline Developments & Deals for Berberine Ursodeoxycholate

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                          01

                          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

                          Quotient

                          02

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                          Not Confirmed
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                          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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                          03

                          Luxepack
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                          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

                          Luxepack
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                          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

                          Luxepack
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                          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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                          06

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                          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

                          Luxepack
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                          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

                          Luxepack
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                          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

                          Luxepack
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                          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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