chenodeoxycholic acid

Trade name: Chenix

Small moleculeapproved

Approved

Jul 28, 1983

Chenodeoxycholic acid is a bile acid. Salts of this carboxylic acid are called chenodeoxycholates. Chenodeoxycholic acid is one of the main bile acids. It was first isolated from the bile of the domestic goose, which gives it the "cheno" portion of its name. — Wikipedia

Clinical trial activity

16 trials · 15 clinical orgs · 5 marketing orgs

Phase 1
3
Phase 2
4
Phase 3
1
Phase 4
6

Earliest trial started Jan 1, 1996 (NCT00004346)

Timeline

1980s

  1. Jul 28, 1983

    Earliest FDA Approval

  2. Jul 28, 1983

    Leadiant Biosciences, Inc. — NDA Secondary Org

1990s

  1. Jan 1, 1996

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Oct 22, 2009

    LGM Pharma — Marketing Organization

  3. Oct 22, 2009

    Nexgen Pharma, Inc — Marketing Organization

2020s

  1. Jan 1, 2024

    Leadiant Biosciences, Inc. — Earliest Phase 3 Sponsor(trial)

  2. Feb 21, 2025

    Mirum Pharmaceuticals, Inc. — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewJul 28, 1983

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](CCC(=O)O)[C@H]1CC[C@H]2[C@@H]3[C@H](O)C[C@@H]4C[C@H](O)CC[C@]4(C)[C@H]3CC[C@]12C
Mol. weight
392.58 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 3alpha,7alpha-dihydroxy-5beta-cholanic acid
  • 3alpha,7alpha-dihydroxy-5beta-cholanic acid
  • 7alpha-hydroxylithocholic acid
  • 7alpha-hydroxylithocholic acid
  • anthropodeoxycholic acid
  • anthropodeoxycholic acid
  • anthropodesoxycholic acid
  • anthropodesoxycholic acid
  • anthropodesoxycholic acid
  • anthropododesoxycholic acid
  • cdca
  • cdca
  • chendol 125
  • chendol 250
  • chenic acid
  • chenic acid
  • chenic acid
  • chenic acid
  • chenix
  • chenix
  • chenix
  • chenocedon
  • chenocedon
  • chenocholic acid
  • chenocholic acid
  • chenodeoxycholate
  • chenodeoxycholate
  • chenodeoxycholic acid
  • chenodeoxycholic acid
  • chenodeoxycholic acid
  • chenodeoxycholic acid
  • chenodeoxycholic acid
  • chenodeoxycholic acid
  • chenodeoxycholic acid
  • chenodesoxycholic acid
  • chenodesoxycholic acid
  • chenodesoxycholic acid
  • chenodiol
  • chenodiol
  • chenodiol
  • chenodiol
  • chenodiol
  • chenodiol
  • chenodiol
  • chenodiol
  • chenodiol
  • chenofalk
  • chenofalk
  • combidol
  • gallodesoxycholic acid
  • gallodesoxycholic acid
  • gallodesoxycholic acid
  • lithofalk
  • sodium chenodeoxycholate
  • sodium chenodeoxycholate
  • xenbilox
  • xenbilox
  • xenbilox

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07005752Phase 4Jul 28, 2025Myungmoon Pharm. Co.
NCT06260748Phase 3May 27, 2024Leadiant Biosciences, Inc.
NCT06180057Phase 1Jun 12, 2022Humanis Saglık Anonim Sirketi
NCT03168555Phase 4Jun 1, 2017University of Copenhagen
NCT03059537Phase 4Mar 13, 2017University of Copenhagen
NCT02952963Phase 4Oct 1, 2016University of Copenhagen
NCT02876484Phase 4Jun 1, 2016University of Copenhagen
NCT02314208Phase 2Jan 1, 2015Institut National de la Santé Et de la Recherche Médicale, France, University of Paris
NCT02340247Phase 4Nov 1, 2014University of Copenhagen
NCT01666223N/ANov 1, 2012University of Copenhagen
NCT01674946Phase 1Sep 1, 2011University of Basel, University of Bern
NCT00912301Phase 2Apr 1, 2009Mayo Clinic, National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT00465751Early Phase 1 (Phase 1)Oct 1, 2004Cantonal Hospital of St. Gallen, University of Bern
NCT00004442N/AOct 18, 1999University of Cincinnati
NCT00018694N/AOct 1, 1999Department of Veteran Affairs
NCT00004346Phase 2Jan 1, 1996National Center for Research Resources (NCRR), Oregon Health and Science University
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (15)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of CopenhagenAcademic/Hospital6622012
National Center for Research Resources (NCRR)Government2111996
University of BernAcademic/Hospital2212004
Cantonal Hospital of St. GallenAcademic/Hospital1012004
Department of Veteran AffairsGovernment1111999
Humanis Saglık Anonim SirketiAcademic/Hospital1112022
Institut National de la Santé Et de la Recherche Médicale, FranceAcademic/Hospital1112015
Leadiant Biosciences, Inc.For profit1112024
Mayo ClinicAcademic/Hospital1112009
Myungmoon Pharm. Co.For profit1112025
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1012009
Oregon Health and Science UniversityAcademic/Hospital1011996
University of BaselAcademic/Hospital1012011
University of CincinnatiAcademic/Hospital1111999
University of ParisAcademic/Hospital1012015
15 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
LGM PharmaFor profitMKTGOct 22, 2009
Leadiant Biosciences, Inc.For profitNDA2Jul 28, 1983
Mirum Pharmaceuticals, Inc.For profitMKTGFeb 21, 2025
Nexgen Pharma, IncFor profitMKTGOct 22, 2009
Rowell LaboratoriesFor profitNDA