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(Liver, Pancreatic, Gall Bladder)","graph2":"Phase II","graph3":"HighTide Therapeutics","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Hepatology","amount2New":0,"dosageForm":"Oral Tablet","sponsorNew":"HighTide Therapeutics \/ Inapplicable","highestDevelopmentStatusID":"8","companyTruncated":"HighTide Therapeutics \/ Inapplicable"}]

Find Clinical Drug Pipeline Developments & Deals by HighTide Therapeutics

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                          Therapeutic Area by Lead Product

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                          Top Deals by Deal Size (USD bn)

                          01

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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.

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Undisclosed

                          May 01, 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

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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.

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          October 25, 2022

                          Lead Product(s) : Berberine Ursodeoxycholate

                          Therapeutic Area : Endocrinology

                          Highest Development Status : Phase II

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          03

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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...

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          August 30, 2022

                          Lead Product(s) : Berberine Ursodeoxycholate

                          Therapeutic Area : Endocrinology

                          Highest Development Status : Phase II

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          04

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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.

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          April 29, 2022

                          Lead Product(s) : Berberine Ursodeoxycholate

                          Therapeutic Area : Endocrinology

                          Highest Development Status : Phase II

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          05

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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.

                          Product Name : HTD1801

                          Product Type : Other 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 : US Food & Drug Administration

                          Deal Size : Undisclosed

                          Deal Type : Agreement

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                          06

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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.

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          February 22, 2022

                          Lead Product(s) : Berberine Ursodeoxycholate

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

                          Highest Development Status : Phase II

                          Sponsor : US Food & Drug Administration

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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.

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          October 28, 2021

                          Lead Product(s) : Berberine Ursodeoxycholate

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

                          Highest Development Status : Phase II

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          08

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

                          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.

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          December 15, 2020

                          Lead Product(s) : Berberine Ursodeoxycholate

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

                          Highest Development Status : Phase II

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          09

                          Iran Expo
                          Not Confirmed
                          Iran Expo
                          Not Confirmed

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

                          Product Name : HTD1801

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          July 05, 2020

                          Lead Product(s) : Berberine Ursodeoxycholate

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

                          Highest Development Status : Phase II

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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