Shenzhen Hightide Biopharmaceutical, Ltd.

Mannkind Corporation

Zte Corporation

Stealth Biotherapeutics Inc.

Stealth Peptides International, Inc.

American Type Culture Collection

Liping Liu

David C Diamond

Ru Bai

Adrian Ion Bot

Xiaoling Liang

Shibo Tang

Yuanchun Tan

Xianxi Li

Focai Peng

Xinxiang Fu

Zhidong Xie

Jian Gong

Meng Yu

Feng Zhang

Yang Guo

Cohava Gelber

Chih-Sheng Chiang

Zhiyong Qiu

Xiping Liu

Wei Lei

Chunhui Song

Hua Sun

Kent Andrew Smith

Pranvera Ikonomi

John R Simms

Catherine R Auge

Juanjuan Liu

Kent Smith

The invention generally relates to solid forms of berberine ursodeoxycholate, and to pharmaceutical compositions, and methods of preparation and therapeutic use thereof. In particular, the invention relates to solid forms of berberine ursodeoxycholate and pharmaceutical compositions thereof useful in treating and/or preventing various diseases or disorders, including metabolic disorders, heart diseases, neurodegenerative diseases and liver diseases.

Solid forms of berberine ursodeoxycholate and compositions and methods thereof

The invention provides various novel compositions of berberine in combination with pharmacologically active organic acids, and related methods of their use in treating various diseases or disorders. The invention further provides various novel compounds prepared from berberine and pharmacologically active organic acids and prepared from ursodeoxycholic acid and pharmacologically active organic bases, and pharmaceutical compositions thereof, and methods of their preparation and therapeutic use in treating and/or preventing various diseases or disorders. The compounds and pharmaceutical compositions of the invention can be utilized to treat various diseases or disorders, such as diabetes, diabetic complications, dyslipidemia, hyperlipidemia, obesity, metabolic syndromes, pre-diabetes, atherosclerosis, heart diseases, neurodegenerative diseases, sarcopenia, muscle atrophy, inflammation, cancer and liver diseases and conditions such as fatty liver, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, cholestatic liver diseases or graft-versus-host disease of the liver. The compounds of this invention are also useful in improving liver functions in chronic viral associated liver diseases and alcohol-related liver diseases.

Pharmaceutical composition comprising berberine and ursodeoxycholic acid for the treatment of various diseases or disorders

The disclosure generally describes methods of preventing or treating ophthalmic diseases or conditions in a mammalian subject, such as diabetic retinopathy, cataracts, retinitis pigmentosa, glaucoma, macular degeneration, choroidal neovascularization, retinal degeneration, and oxygen-induced retinopathy. The methods comprise administering an effective amount of an aromatic-cationic peptide to subjects in need thereof.

Methods and compositions for preventing or treating ophthalmic conditions

The invention provides various novel compositions of berberine in combination with pharmacologically active EPA and DHA, and related methods of their use in treating various diseases or disorders. The pharmaceutical compositions of the invention are useful in treating and/or preventing various diseases or disorders, including metabolic diseases or disorders such as dyslipidemia, hyperglycemia, hypertriglyceridemia, hyperlipidemia, diabetic dyslipidemia, diabetic hyperlipidemia, dyslipidemia in statin-intolerance patients, diabetes, diabetic complications, hypercholesterolemia, or obesity. Additionally, the pharmaceutical compositions of the invention are useful in treating and/or preventing atherosclerosis, heart diseases, neurodegenerative diseases, inflammation, cancers, as well as various liver diseases or disorders, such as fatty liver, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, cholestatic liver diseases or graft-versus-host disease of the liver. Furthermore, the pharmaceutical compositions of the invention are useful in improving liver functions in chronic viral associated liver diseases and alcohol-related liver diseases.

Pharmaceutical compositions of berberine with EPA and DHA, and methods thereof

The invention provides novel pharmaceutical compositions of berberine or a derivative or analog of berberine, or a salt thereof, in combination with one or more omega-3 fatty acids or esters thereof, and methods of their use in treating inflammatory bowel disease.

Methods and compositions for treatment of inflammatory bowel disease

The invention provides novel compounds, in particular peptide and peptide analogs, which exhibit functionalities useful for treating a variety of diseases and conditions, particularly diseases and conditions relating to diabetes. The compounds of the invention are also useful for treating impaired pancreatic function, treating metabolic diseases, ex vivo islet induction, expansion and proliferation for transplantation, increasing the survival of transplanted islets in vivo, promoting neuroprotection or nerve regeneration, promoting liver regeneration, and inhibiting inflammation.

Conjugates of islet neogenesis peptides and analogs, and methods thereof

Pharmaceutical composition comprising berberine salts for the treatment of various diseases or disorders

This invention discloses certain methods of treating acute pancreatitis and inflammatory pancreatic disease or condition. The disclosed peptides and analogs can significantly lower the elevated blood amylase and lipase levels caused by acute pancreatitis and pancreatic inflammation, reduce the degree of injury observed in pancreatic histopathology caused by pancreatitis, and significantly lower the mortality rate of acute pancreatitis.

Use of peptide compounds in treating acute pancreatitis

Pharmaceutical composition comprising berberine ursodeoxycholic acid salt for the treatment of various diseases or disorders

The invention provides peptides and analogs of INGAP and HIP peptides. The peptides and analogs can be used in methods for treating various diseases and conditions. Such diseases and conditions can include impaired pancreatic function, treating a metabolic disease, for example, diabetes, both type 1 and type 2 diabetes, islets induction, expansion and proliferation for transplantation, promoting neuroprotection or nerve regeneration, promoting liver regeneration or inhibiting inflammation.

Compositions and methods of using islet neogenesis peptides and analogs thereof

Method of use of peptides and their analogs in the treatment of acute pancreatitis are described. The disclosed peptides and analogs can significantly lower the elevated blood amylase and lipase levels caused by acute pancreatitis, reduce the degree of injury observed in pancreatic histopathology caused by pancreatitis, and significantly lower the mortality rate of acute pancreatitis.

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Manassas, VA, United States of America

Liping Liu