Chenodeoxycholic acid

Overview

Chenodeoxycholic acid (or Chenodiol) is an epimer of ursodeoxycholic acid (DB01586). Chenodeoxycholic acid is a bile acid naturally found in the body. It works by dissolving the cholesterol that makes gallstones and inhibiting production of cholesterol in the liver and absorption in the intestines, which helps to decrease the formation of gallstones. It can also reduce the amount of other bile acids that can be harmful to liver cells when levels are elevated.

Indication

Chenodiol is indicated for patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age. Chenodiol will not dissolve calcified (radiopaque) or radiolucent bile pigment stones.

Associated Conditions

Radiolucent Cholesterol gallstones

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX)	2024/02/15	NCT06260748	Phase 3	Withdrawn	Leadiant Biosciences, Inc.
Bioequivalence Study to Compare Chenodeoxycholic Acid Capsules (250mg Chenodeoxycholic Acid) Versus Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules (250mg Chenodeoxycholic Acid)	2023/12/22	NCT06180057	Phase 1	Completed	Humanis Saglık Anonim Sirketi
Safety and Efficacy of CDCA in CTX Chenodeoxycholic Acid (CDCA) in Patients Affected by Cerebrotendinous Xanthomatosis (CTX)	2022/08/12	NCT05499026	N/A	Completed	Leadiant Biosciences Ltd.
Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)	2020/02/17	NCT04270682	Phase 3	Completed	Mirum Pharmaceuticals, Inc.
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy	2017/05/30	NCT03168555	Phase 4	Completed	Zealand University Hospital
Effect of Bile Acids and Bile Acid Sequstrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass	2016/11/02	NCT02952963	Phase 4	Completed	Hvidovre University Hospital
Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass	2016/08/23	NCT02876484	Phase 4	Completed	Hvidovre University Hospital
Effects of Bile Acids on GLP-1 Secretion After Roux-en-Y Gastric Bypass	2015/01/16	NCT02340247	Phase 4	Completed	Hvidovre University Hospital
Effect of Bile Acids on GLP-1 Secretion	2012/08/16	NCT01666223	Not Applicable	Completed	University Hospital, Gentofte, Copenhagen
Cheno Effect on Transit in Health and IBS-C	2009/06/03	NCT00912301	Phase 2	Completed	Mayo Clinic

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Chenodiol	LGM PHARMA SOLUTIONS, LLC	79739-7121	ORAL	250 mg in 1 1	4/28/2023
Chenodal	Travere Therapeutics	68974-876	ORAL	250 mg in 1 1	7/7/2023
Chenodiol	Nexgen Pharma, Inc.	0722-7121	ORAL	250 mg in 1 1	9/6/2019
Chenodal	Manchester Pharmaceuticals Inc.	45043-876	ORAL	250 mg in 1 1	1/7/2010

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)	Leadiant GmbH,Liebherrstrasse 22,80538 München,Germany	Authorised	4/10/2017

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
Chenodeoxycholic Acid Capsules	甘肃成纪生物药业有限公司	国药准字H62020139	化学药品	胶囊剂	4/10/2020
Chenodeoxycholic Acid Capsules	贵州省科晖制药有限公司	国药准字H52020422	化学药品	胶囊剂	11/15/2019
Chenodeoxycholic Acid Capsules	盘锦恒昌隆药业有限公司	国药准字H21022058	化学药品	胶囊剂	5/12/2020
Chenodeoxycholic Acid Capsules	新疆生化药业有限公司	国药准字H65020377	化学药品	胶囊剂	7/19/2022
Chenodeoxycholic Acid Capsules	山东司邦得制药有限公司	国药准字H37023014	化学药品	胶囊剂	12/23/2021
Chenodeoxycholic Acid Capsules	辽宁玉皇药业有限公司	国药准字H21023559	化学药品	胶囊剂	5/29/2020
Chenodeoxycholic Acid Capsules	沈阳君元药业有限公司	国药准字H21021155	化学药品	胶囊剂	1/11/2022
Chenodeoxycholic Acid Capsules	重庆科瑞南海制药有限责任公司	国药准字H20163483	化学药品	胶囊剂	12/27/2021
Chenodeoxycholic Acid Capsules	蚌埠丰原涂山制药有限公司	国药准字H34023916	化学药品	胶囊剂	6/29/2020
Chenodeoxycholic Acid Capsules	山东鲁北药业有限公司	国药准字H37021658	化学药品	胶囊剂	4/22/2020

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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The FDA has approved chenodeoxycholic acid (Ctexli) as the first official treatment for cerebrotendinous xanthomatosis (CTX), a rare genetic disorder that affects cholesterol metabolism and causes progressive neurological damage.

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