CDEK
← All drugs Report issue

cholic acid

Trade name: cholbam

Small moleculeapprovedOrphan Drug FDA

Approved

Mar 17, 2015

Cholic acid, also known as 3α,7α,12α-trihydroxy-5β-cholan-24-oic acid is a primary bile acid that is insoluble in water, it is a white crystalline substance. Salts of cholic acid are called cholates. Cholic acid, along with chenodeoxycholic acid, is one of the two major bile acids produced by the liver, where it is synthesized from cholesterol. These two major bile acids are roughly equal in concentration in humans. Derivatives are made from cholyl-CoA, which exchanges its CoA with either glycine, or taurine, yielding glycocholic and taurocholic acid, respectively. — Wikipedia

Clinical trial activity

11 trials · 11 clinical orgs · 3 marketing orgs

Phase 1
3
Phase 2
7
Phase 3
4
Phase 4
1

Earliest trial started Jan 1, 1992 (NCT00007020)

Timeline

1990s

  1. Jan 1, 1992

    Travere — Earliest Phase 3 Sponsor(trial)

2000s

  1. Jul 18, 2003

    Orphan Drug Designation

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  2. Mar 17, 2015

    Asklepion — Earliest FDA Approval

  3. Mar 17, 2015

    Travere — Marketing Organization

  4. Mar 17, 2015

    Asklepion — NDA Organization

  5. Mar 17, 2015

    Travere — NDA Secondary Org

  6. Mar 17, 2015

    Mirum Pharmaceuticals, Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Approval history

  • approvedPriority reviewMar 17, 2015

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]3C[C@H](O)[C@]12C
Mol. weight
408.5714 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

  • cholalic acid
  • cholalin
  • cholate
  • cholate
  • cholbam
  • cholbam
  • cholbam
  • cholic acid
  • cholic acid
  • cholic acid
  • cholic acid
  • cholic acid
  • cholic acid
  • cholic acid
  • cholic acid
  • cholic acid
  • cholic acid
  • colalin
  • e1000
  • e1000
  • kolbam
  • orphacol
  • orphacol
  • orphacol
  • orphacol
  • orphacol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05195112Phase 3Dec 24, 2021Medy-Tox
NCT04144049Phase 2Sep 10, 2019Medy-Tox
NCT03720990Phase 1/Phase 2 (Phase 2)Apr 1, 2019University of Cincinnati, University of Colorado, University of Colorado, Denver, University of Nebraska, University of Pittsburgh
NCT04101500Phase 4Apr 1, 2019Huazhong University of Science and Technology
NCT03905291Phase 1Jul 31, 2018Medy-Tox
NCT02506335Early Phase 1 (Phase 1)Jun 1, 2015Northwestern University, University of Colorado, Denver
NCT01115582Phase 3Apr 1, 2010Travere, University of Cincinnati
NCT01438411Phase 3Jan 1, 2010Travere, University of Cincinnati
NCT00457639Phase 2Apr 1, 2006Food and Drug Administration, The University of Texas, Dallas
NCT00004442N/AOct 18, 1999University of Cincinnati
NCT00007020Phase 3Jan 1, 1992Travere, University of Cincinnati
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of CincinnatiAcademic/Hospital5131992
Medy-ToxFor profit3332018
TravereFor profit3311992
University of Colorado, DenverAcademic/Hospital2022015
Food and Drug AdministrationGovernment1012006
Huazhong University of Science and TechnologyAcademic/Hospital1112019
Northwestern UniversityAcademic/Hospital1112015
The University of Texas, DallasAcademic/Hospital1112006
University of ColoradoAcademic/Hospital1012019
University of NebraskaAcademic/Hospital1112019
University of PittsburghAcademic/Hospital1012019
11 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
AsklepionFor profitNDAMar 17, 2015
Mirum Pharmaceuticals, Inc.For profitMKTGMar 17, 2015
TravereFor profitMKTGMar 17, 2015
TravereFor profitNDA2Mar 17, 2015