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ursodeoxycholic acid

Small moleculeapproved

Approved

Dec 31, 1987

Ursodoxicoltaurine is the international nonproprietary name (INN) for the pharmaceutical form of tauroursodeoxycholic acid (TUDCA). It is also known as taurursodiol. Tauroursodeoxycholic acid is a naturally occurring hydrophilic bile acid which is the taurine conjugated form of ursodeoxycholic acid (UDCA). Humans have only trace amounts of tauroursodeoxycholic acid but bears have large amounts of tauroursodeoxycholic acid and ursodeoxycholic acid in their bile. — Wikipedia

Clinical trial activity

175 trials · 190 clinical orgs · 28 marketing orgs

Phase 1
34
Phase 2
79
Phase 3
49
Phase 4
28

Earliest trial started Nov 1, 1989 (NCT00004748)

Timeline

1980s

  1. Dec 31, 1987

    Earliest FDA Approval

  2. Dec 31, 1987

    Allergan — Marketing Organization

  3. Dec 31, 1987

    Allergan — NDA Secondary Org

  4. Dec 31, 1987

    Teva — NDA Secondary Org

  5. Jan 1, 1989

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  2. Dec 10, 1997

    SmithKline Beecham — NDA Secondary Org

  3. Dec 10, 1997

    AbbVie — Marketing Organization

2000s

  1. Mar 14, 2000

    Epic Pharma Llc — Marketing Organization

  2. May 25, 2000

    Teva — Marketing Organization

  3. Jan 1, 2006

    Teva — Earliest Phase 1 Sponsor(trial)

  4. Jul 27, 2006

    Impax Laboratories — Marketing Organization

  5. Dec 15, 2008

    Lannett Company, Inc. — Marketing Organization

2010s

  1. Feb 17, 2010

    Mylan — Marketing Organization

  2. Feb 17, 2010

    Quagen Pharma — Marketing Organization

  3. Jul 12, 2011

    Glenmark Pharmaceuticals — Marketing Organization

  4. Feb 14, 2013

    Par Pharmaceuticals — Marketing Organization

  5. Feb 14, 2013

    PH HEALTH — Marketing Organization

  6. May 17, 2018

    Abhai LLC — Marketing Organization

  7. Oct 16, 2018

    Amneal Pharmaceuticals — Marketing Organization

  8. Oct 30, 2018

    Zydus Discovery DMCC — Marketing Organization

  9. Oct 30, 2019

    Eywa Pharma — Marketing Organization

  10. Oct 30, 2019

    HIBROW HLTHCARE — Marketing Organization

2020s

  1. Feb 12, 2020

    Rising Pharmaceuticals — Marketing Organization

  2. May 8, 2020

    Nexgen Pharma, Inc — Marketing Organization

  3. May 8, 2020

    LGM Pharma — Marketing Organization

  4. Aug 17, 2020

    Chartwell Pharmaceuticals — Marketing Organization

  5. Aug 17, 2020

    Upsher-Smith Laboratories — Marketing Organization

  6. Aug 20, 2020

    Strides Pharma Science — Marketing Organization

  7. Jul 28, 2021

    Vgyaan — Marketing Organization

  8. Jul 28, 2021

    Apicore — Marketing Organization

  9. Sep 29, 2022

    Amylyx Pharmaceuticals Inc. — NDA Secondary Org

  10. Nov 28, 2022

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewDec 31, 1987

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](CC(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
378.5454 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

Sources

Also known as

  • 24-norcholan-23-oic acid, 3,7-dihydroxy-, (3alpha,5beta,7beta)-
  • 24-norursodeoxycholic acid
  • 24-norursodeoxycholic acid
  • 24-norursodeoxycholic acid
  • 2-methyl-3-(2-((4-nitrooxybutyloxy)carbonyl)vinyl)phenyl ursodeoxycholic acid ester
  • (3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid
  • (3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid
  • 3alpha,7beta-dihydroxy-5beta-cholan-24-oic acid
  • 3alpha,7beta-dihydroxy-5beta-cholan-24-oic acid
  • (3α,5β,7β)-3,7-dihydroxycholan-24-oic acid
  • (3α,5β,7β)-3,7-dihydroxycholan-24-oic acid
  • acide ursodesoxycholique
  • acide ursodesoxycholique
  • acido ursodeossicolico
  • acido ursodeossicolico
  • acido ursodeoxicolico
  • acido ursodeoxicolico
  • acidum ursodeoxycholicum
  • acidum ursodeoxycholicum
  • actigall
  • actigall
  • actigall
  • bifendatatum
  • cholurso
  • deoxyursocholic acid
  • destolit
  • destolit
  • dwj1319
  • dwp10292
  • human menstrual blood-derived mesenchymal stem cells
  • ncx1000
  • ncx 1000
  • ncx-1000
  • ncx-1000
  • ncx-1000
  • nor-udca
  • no-udca
  • udca
  • udca
  • udca
  • urdox
  • urdox
  • urosiol
  • urosiol
  • urosiol
  • urosiol
  • urosiol
  • urosiol
  • ursacholic acid
  • urso
  • urso
  • urso 250
  • urso 250
  • ursochol
  • ursochol
  • ursocol
  • ursodeoxycholate
  • ursodeoxycholate
  • ursodeoxycholate
  • ursodeoxycholic acid
  • ursodeoxycholic acid
  • ursodeoxycholic acid
  • ursodeoxycholic acid
  • ursodeoxycholic acid
  • ursodeoxycholic acid
  • ursodesoxycholic acid
  • ursodesoxycholic acid
  • ursodesoxycholic acid
  • ursodiol
  • ursodiol
  • ursodiol
  • ursodiol
  • ursodiol
  • ursodiol
  • ursodiol
  • ursodiol
  • ursofalk
  • ursofalk
  • urso forte
  • urso forte
  • ursogal
  • ursogal
  • ursolvan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07273734N/AJan 1, 2026Chongqing Medical University, Kunming Medical University, Sichuan University
NCT07296458Phase 3Dec 17, 2025People's Liberation Army of China
NCT06884748Early Phase 1 (Phase 1)Dec 1, 2025Medical College of Wisconsin
NCT07102979N/ASep 1, 2025Chang Gung University
NCT07100392Phase 2Aug 14, 2025Fudan University
NCT07064668Phase 2Jul 30, 2025Huazhong University of Science and Technology
NCT07005752Phase 4Jul 28, 2025Myungmoon Pharm. Co.
NCT07110987N/AJun 26, 2025Tishreen University
NCT06922669N/AJun 24, 2025Government of China, Huazhong University of Science and Technology, People's Liberation Army of China, Shandong University, Tianjin Medical University
NCT07068191N/AJun 19, 2025Phenomen Pharma
NCT06827873N/AFeb 28, 2025Tsinghua University
NCT06842472Phase 2Feb 28, 2025Chinese Academy of Medical Sciences
NCT06684106N/ANov 11, 2024Jiao Tong University
NCT06610760Phase 4Nov 1, 2024Air Force Military Medical University, China, People's Liberation Army of China
NCT06443606Phase 3Sep 30, 2024Assistance Publique - Hôpitaux de Paris
NCT06591468Phase 2/Phase 3 (Phase 3)Sep 15, 2024People's Liberation Army of China
NCT06591455Early Phase 1 (Phase 1)Sep 15, 2024People's Liberation Army of China
NCT06517862Phase 4Sep 1, 2024Ain Shams University, Egyptian Chinese University, Future University in Egypt
NCT06294847Phase 3Jul 31, 2024University of Versailles
NCT06755541Phase 3Jan 30, 2024People's Liberation Army of China
Showing 20 of 175 trials
Page 1 / 9

Organizations

Research & Development (190)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
People's Liberation Army of ChinaGovernment181652009
Daewoong Pharmaceutical Co. LTD.For profit121142011
Amylyx Pharmaceuticals Inc.For profit9932018
Dr. Falk Pharma GmbHFor profit7542001
Sichuan UniversityAcademic/Hospital6432009
Chinese Academy of Medical SciencesAcademic/Hospital5532011
Jiao Tong UniversityAcademic/Hospital5432005
Huazhong University of Science and TechnologyAcademic/Hospital4232009
Fudan UniversityAcademic/Hospital3232009
Katholieke Universiteit LeuvenAcademic/Hospital3122017
Medical University of ViennaAcademic/Hospital3022012
Menoufia UniversityAcademic/Hospital3022021
National Cancer Institute (NCI)Government3122003
National Center for Research Resources (NCRR)Government3321989
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government3221994
Seoul National UniversityAcademic/Hospital3212011
Sheffield Hallam UniversityAcademic/Hospital3122018
Tanta UniversityAcademic/Hospital3322021
University of AmsterdamAcademic/Hospital3032007
University of CincinnatiAcademic/Hospital3221995
190 organizations
Page 1 / 10

Marketing (35)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGDec 10, 1997
Abhai LLCFor profitMKTGMay 17, 2018
AllerganFor profitMKTGDec 31, 1987
AllerganFor profitNDA2Dec 31, 1987
Amneal PharmaceuticalsFor profitMKTGOct 16, 2018
Amylyx Pharmaceuticals Inc.For profitNDA2Sep 29, 2022
ApicoreFor profitMKTGJul 28, 2021
Aurobindo PharmaFor profitMKTGNov 28, 2022
Chartwell PharmaceuticalsFor profitMKTGAug 17, 2020
Ciba-GeigyFor profitNDA—
Epic Pharma LlcFor profitMKTGMar 14, 2000
Epic Pharma LlcFor profitSYNAug 14, 2024
Eywa PharmaFor profitMKTGOct 30, 2019
Glenmark PharmaceuticalsFor profitMKTGJul 12, 2011
Glenmark PharmaceuticalsFor profitSYNJul 12, 2011
HIBROW HLTHCAREFor profitMKTGOct 30, 2019
Impax LaboratoriesFor profitMKTGJul 27, 2006
LGM PharmaFor profitMKTGMay 8, 2020
Lannett Company, Inc.For profitMKTGDec 15, 2008
MylanFor profitMKTGFeb 17, 2010
Nexgen Pharma, IncFor profitMKTGMay 8, 2020
PH HEALTHFor profitMKTGFeb 14, 2013
Par PharmaceuticalsFor profitMKTGFeb 14, 2013
Quagen PharmaFor profitMKTGFeb 17, 2010
Rising PharmaceuticalsFor profitMKTGFeb 12, 2020
SmithKline BeechamFor profitNDA2Dec 10, 1997
Strides Pharma ScienceFor profitMKTGAug 20, 2020
TevaFor profitSYNDec 31, 1987
TevaFor profitMKTGMay 25, 2000
TevaFor profitSYNMay 13, 2009
TevaFor profitNDA2Dec 31, 1987
Upsher-Smith LaboratoriesFor profitMKTGAug 17, 2020
VgyaanFor profitMKTGJul 28, 2021
Zydus Discovery DMCCFor profitMKTGOct 30, 2018
Zydus Discovery DMCCFor profitSYNOct 30, 2018