Obeticholic Acid
Small molecule targets NR1H4 via activation
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Ocaliva | — | 2024-08-30 | europa.eu ↗ |
| Approved · conditional | EU (EMA) | Ocaliva | — | 2016-12-12 | europa.eu ↗ |
| Approved | US (FDA) | OCALIVA | — | 2016-05-27 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03253276 Comparator | May 2016 → Sep 2018 | primary biliary cholangitis | University of Aarhus | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02532335 Comparator | Aug 2015 → Dec 2020 | obesity disorder | Sahlgrenska University Hospital | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05573204 Comparator | Sep 2021 → Oct 2026 expected | metabolic dysfunction-associated steatohepatitis | Tanta University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01625026 Comparator | Sep 2013 → Apr 2016 | gallstones, obesity disorder | Sahlgrenska University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01265498 Comparator | Mar 2011 → Jan 2014 | NAFLD1, metabolic dysfunction-associated steatohepatitis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 2 | NCT00501592 Comparator | Jul 2007 → Feb 2009 | fatty liver disease, type 2 diabetes mellitus | Intercept Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06121375 Comparator | Sep 2024 → Oct 2025 | biliary atresia | Intercept Pharmaceuticals | Terminated | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Obeticholic acid | “An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects...” NCT06488911 ↗32“Obeticholic acid (OCA; INT-747, 6α-ethyl-chenodeoxycholic acid) is a semisynthetic derivative of the primary human bile acid” PMID 23727264 ↗ May 2013 “Obeticholic Acid (OCA) Compared to Placebo” NCT06121375 ↗ |
| Known as | 6-ecdca | ChEMBL registry synonym — accepted as the source's own label CHEMBL566315 ↗ |
| Known as | 6-ethylchenodeoxycholic acid | “Obeticholic acid (OCA, 6-ethyl-chenodeoxycholic acid, INT-747) is a semi-synthetic derivative of the major human bile acid chenodeoxycholic acid” NCT02532335 ↗1“The bile acid derivative 6-ethylchenodeoxycholic acid (obeticholic acid) is a potent activator of the farnesoid X nuclear receptor” PMID 25468160 ↗ Nov 2014 |
| Known as | 6α-ethyl-chenodeoxycholic acid | “Obeticholic acid (OCA; INT-747, 6α-ethyl-chenodeoxycholic acid) is a semisynthetic derivative of the primary human bile acid” PMID 23727264 ↗ May 2013 |
| Known as | Acide obeticholique | ChEMBL registry synonym — accepted as the source's own label CHEMBL566315 ↗ |
| Known as | Acido obeticolico | ChEMBL registry synonym — accepted as the source's own label CHEMBL566315 ↗ |
| Known as | DSP-1747 | ChEMBL registry synonym — accepted as the source's own label CHEMBL566315 ↗ |
| Known as | INT-747 | “Obeticholic acid (OCA; INT-747, 6α-ethyl-chenodeoxycholic acid) is a semisynthetic derivative of the primary human bile acid” PMID 23727264 ↗ May 20132“Obeticholic Acid (INT-747, Intercept) (OCA) is a FXR agonist and induces BSEP.” NCT03253276 ↗ |
| Known as | OCA | “An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects...” NCT06488911 ↗25“Obeticholic acid (OCA), a semisynthetic bile acid, is a selective and potent farnesoid X receptor (FXR) agonist in development for the treatment of chronic nonviral liver diseases.” PMID 27743502 ↗ Oct 2016 “Obeticholic acid (OCA, 6-ethyl-chenodeoxycholic acid, INT-747) is a semi-synthetic derivative of the major human bile acid chenodeoxycholic acid” NCT02532335 ↗ “10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.” NCT02039219 ↗ “10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.” NCT02654236 ↗ “In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus” NCT04053023 ↗ “The nuclear farnesoid X receptor (FXR) agonist obeticholic acid (OCA) has been developed for the treatment of liver diseases.” PMID 31254596 ↗ Jun 2019 “Obeticholic acid (OCA; INT-747, 6α-ethyl-chenodeoxycholic acid) is a semisynthetic derivative of the primary human bile acid” PMID 23727264 ↗ May 2013 “Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis” NCT01865812 ↗ “Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)” NCT04956328 ↗ “Capsules of obeticholic acid (OCA) or an identical placebo in the dose of 25 mg/day for a period of 4 months .” NCT02430077 ↗ “This phase IIa trial investigates if giving obeticholic acid (OCA) is safe and has a beneficial effect” NCT05223036 ↗ “effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and its conjugates” NCT05133830 ↗ “In FLINT, obeticholic acid (OCA) treatment improved multiple histological NASH features.” PMID 31260793 ↗ Jun 2019 “The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist” NCT02308111 ↗ “Obeticholic acid (OCA) is a semisynthetic derivative of the chenodeoxycholic acid.” NCT05573204 ↗ “Obeticholic Acid (INT-747, Intercept) (OCA) is a FXR agonist and induces BSEP.” NCT03253276 ↗ “Obeticholic acid (OCA) is an agonist of the farnesoid X receptor (FXR)” NCT06691412 ↗ “Obeticholic Acid (OCA) Compared to Placebo” NCT06121375 ↗ “Obeticholic acid (OCA) 10mg, Group A” NCT07104786 ↗ “Drug: Obeticholic Acid Tablets（OCA）” NCT05450887 ↗ “Obeticholic Acid (OCA)” NCT01473524 ↗ “Obeticholic Acid (OCA)” NCT03633227 ↗ “Obeticholic Acid (OCA)” NCT00570765 ↗ “Obeticholic Acid (OCA)” NCT02177136 ↗ |
| Known as | Ocaliva | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05740631 ↗ |
| Action | Activate | “the farnesoid X receptor agonist” PMID 23727264 ↗ May 2013 |
| Modality | Small molecule | “is a semisynthetic derivative of the primary human bile acid” PMID 23727264 ↗ May 2013 |
| Route | Oral | “25 mg by mouth once daily, 50 mg by mouth once daily” NCT00501592 ↗ |
| Target | NR1H4 | “potent farnesoid X receptor (FXR) agonist” NCT01585025 ↗ |