Drugs / Cholic Acid
Cholic Acid
also known as
3 alpha,7alpha,12 alpha-trihydroxy-5 beta-cholanoic acid · Cholalic acid · Cholbam · Kolbam · NSC-6135 · Orphacol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CHOLBAM | — | 2015-03-17 | fda.gov ↗ |
| Approved | EU (EMA) | Orphacol | — | 2013-09-12 | europa.eu ↗ |
Trials 6 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03720990 | Mar 2021 → Aug 2022 | Smith-Lemli-Opitz syndrome | University of Nebraska | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00457639 | Apr 2006 → Apr 2011 | fatty liver disease | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01115582 | Apr → Aug 2010 | inborn disorder of bile acid synthesis | Mirum Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01438411 | Jan 2010 → Jul 2016 | congenital bile acid synthesis defect | Mirum Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00007020 | Jan 1992 → Dec 2009 | Zellweger spectrum disorders, adrenoleukodystrophy, cholestasis | Mirum Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00004442 | ? → Apr 1999 | Zellweger spectrum disorders, adrenoleukodystrophy, d-bifunctional protein deficiency | University of Cincinnati | Terminated | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cholic Acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00457639 ↗ |
| Known as | 3 alpha,7alpha,12 alpha-trihydroxy-5 beta-cholanoic acid | “The IUPAC name for cholic acid is 3 alpha,7alpha,12 alpha-trihydroxy-5 beta-cholanoic acid.” NCT01115582 ↗ |
| Known as | Cholalic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL205596 ↗ |
| Known as | Cholbam | ChEMBL registry synonym — accepted as the source's own label CHEMBL205596 ↗ |
| Known as | Kolbam | ChEMBL registry synonym — accepted as the source's own label CHEMBL205596 ↗ |
| Known as | NSC-6135 | ChEMBL registry synonym — accepted as the source's own label CHEMBL205596 ↗ |
| Known as | Orphacol | ChEMBL registry synonym — accepted as the source's own label CHEMBL205596 ↗ |
| Action | Activate | “a farnesoid X receptor agonist” PMID 23447519 ↗ Apr 2013 |
| Modality | Small molecule | — CHEMBL205596 ↗ |
| Route | Oral | “oral cholic acid and oral chenodeoxycholic acid on day 1” NCT00004442 ↗ |