Drugs / Chenodeoxycholic Acid

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) 2017-04-10 europa.eu

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT00004346 Jan 1996 → ? cerebrotendinous xanthomatosis National Center for Research Resources (NCRR) Unknown No outcome recorded
Phase 32 trials
Phase 3 NCT06260748 May 2024 → Nov 2025 cerebrotendinous xanthomatosis Leadiant Biosciences, Inc. Withdrawn No outcome recorded
Phase 3 NCT04270682 Jan 2020 → Jul 2023 Mirum Pharmaceuticals, Inc. Completed No outcome recorded
Phase 45 trials
Phase 4 NCT04640571 Apr → Nov 2021 University of Maryland, Baltimore Completed No outcome recorded
Phase 4 NCT03059537 Mar → Nov 2017 disorder of metabolite absorption and transport Lars Kristian Munck Completed No outcome recorded
Phase 4 NCT02952963 Oct 2016 → Dec 2017 morbid obesity Hvidovre University Hospital Completed No outcome recorded
Phase 4 NCT02876484 Jun 2016 → Jun 2017 morbid obesity Hvidovre University Hospital Completed No outcome recorded
Phase 4 NCT02340247 Nov 2014 → Apr 2015 obesity disorder Hvidovre University Hospital Completed No outcome recorded
Phase not applicable3 trials
NCT01666223 Nov 2012 → Jun 2013 obesity disorder, type 2 diabetes mellitus University Hospital, Gentofte, Copenhagen Completed No outcome recorded
NCT00018694 Oct 1999 → Dec 2009 cerebrotendinous xanthomatosis US Department of Veterans Affairs Withdrawn No outcome recorded
NCT00004442 ? → Apr 1999 Zellweger spectrum disorders, adrenoleukodystrophy, d-bifunctional protein deficiency University of Cincinnati Terminated No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT00465751 Comparator Oct 2004 → ? familial hyperlipidemia, hypertriglyceridemia 2, metabolic syndrome X University Hospital, Basel, Switzerland Completed No outcome recorded
Phase 21 trial
Phase 2 NCT02314208 Comparator Jan 2015 → Sep 2017 hereditary spastic paraplegia French National Institute of Health and Medical Research Completed No outcome recorded
Phase 41 trial
Phase 4 NCT03168555 Background Jun 2017 → May 2019 cholelithiasis, malabsorption syndrome Zealand University Hospital Completed No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as chenodeoxycholic acid “A Phase 3 Study to Evaluate the Effects of Chenodeoxycholic Acid in Adult and Pediatric Patients With Cerebrotendinous Xanthomatosis” NCT04270682
12

NCT03168555

NCT02876484

NCT00004442

NCT04640571

NCT01666223

NCT00465751

NCT02340247

NCT06260748

NCT00004346

NCT03059537

NCT00018694

NCT02952963

Known as Acide chenodesoxycholique ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Acido quenodeoxicolico ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Chendol 125 ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Chendol 250 ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Chenocedon ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Chenodeoxycholic acid leadiant (previously known as chenodeoxycholic acid sigma-tau) ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Combidol ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Lithofalk ChEMBL registry synonym — accepted as the source's own label CHEMBL240597
Known as Xenbilox ClinicalTrials.gov intervention name — accepted as the source's own label NCT02314208
Action Activate “Bile acid receptor FXR agonist” CHEMBL240597
Action Inhibit “replacement of chenodeoxycholic acid in the enterohepatic pool inhibit abnormal bile acid synthesis” NCT00018694
Modality Small molecule CHEMBL240597
Route Oral oral cholic acid and oral chenodeoxycholic acid on day 1” NCT00004442
Target NR1H4 “Bile acid receptor FXR agonist” CHEMBL240597