TP-3654

Overview

Tauroursodeoxycholic acid, also known as ursodoxicoltaurine, is a highly hydrophilic tertiary bile acid that is produced in humans at a low concentration. It is a taurine conjugate of ursodeoxycholic acid with comparable therapeutic efficacy and safety, but a much higher hydrophilicity. Normally, hydrophilic bile acids regulates hydrophobic bile acids and their cytotoxic effects. Tauroursodeoxycholic acid can reduce the absorption of cholesterol in the small intestine, thereby reducing the body's intake of dietary cholesterol and the body cholesterol content. Tauroursodeoxycholic acid is currently used in Europe to treat and prevent gallstones as a bile acid derivative. Due to a range of its molecular properties - namely its anti-apoptotic effects - tauroursodeoxycholic acid has been examined in inflammatory metabolic diseases and neurodegenerative diseases.

Indication

Tauroursodeoxycholic acid is used to prevent and treat gallstone formation. Tauroursodeoxycholic acid is used in combination with phenylbutyric acid to treat amyotrophic lateral sclerosis (ALS) in adults.

Associated Conditions

Amyotrophic Lateral Sclerosis (ALS)
Gallstones

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654	2024/04/29	NCT06389955	Phase 1	Completed	Sumitomo Pharma America, Inc.
Targeting Endoplasmic Reticulum Stress in Human Hypertension	2023/09/06	NCT06025630	Phase 1	Recruiting	University of North Texas Health Science Center
Open Label Extension of TUDCA-ALS Study	2023/03/03	NCT05753852	Phase 3	Recruiting	Humanitas Mirasole SpA
The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.	2021/01/27	NCT04727320	Early Phase 1	UNKNOWN	The First Affiliated Hospital with Nanjing Medical University
Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma	2019/03/18	NCT03878654	Phase 1	Terminated	University of Vermont
Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS	2019/01/11	NCT03800524	Phase 3	Active, not recruiting	Humanitas Mirasole SpA
Study of TP-3654 in Patients With Advanced Solid Tumors	2018/10/23	NCT03715504	Phase 1	Completed	Sumitomo Pharma America, Inc.
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis	2018/02/06	NCT03423121	Phase 1	Completed	Johns Hopkins University
The Discovery of the Double Sphincter in Gallbladder	2013/11/28	NCT01998451	Phase 4	UNKNOWN	The First Affiliated Hospital of Guangzhou Medical University
Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance	2013/06/13	NCT01877551	Not Applicable	Completed	Washington University School of Medicine

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
RELYVRIO	Amylyx Pharmaceuticals Inc	73063-035	ORAL	1 g in 1 1	12/27/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Tauroursodeoxycholic Acid Capsules	BRUSCHETTINI SRL	国药准字HJ20150398	化学药品	胶囊剂	11/2/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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