Drugs / Obeticholic Acid
Obeticholic Acid
also known as
OCA · INT-747 · 6-ethylchenodeoxycholic acid · 6-ecdca · 6α-ethyl-chenodeoxycholic acid · Acide obeticholique · Acido obeticolico · DSP-1747 · +1 more
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| Withdrawn | EU (EMA) | Ocaliva | — | 2024-08-30 | europa.eu ↗ |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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05133830 | Nov 2021 → May 2022 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT04053023 | Aug → Nov 2019 | cholestasis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01904539 | Jun → Oct 2013 | — | Intercept Pharmaceuticals | Completed | No outcome recorded |
| Phase 214 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT04939051 | Jan 2024 → Sep 2027 expected | Barrett esophagus, esophageal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07104786 | Aug → Nov 2023 | NAFLD1 | King Edward Medical University | Completed | No outcome recorded |
| Phase 2 | NCT05223036 | Jan 2023 → Mar 2026 | attenuated familial adenomatous polyposis, carcinoma of duodenum, colorectal carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05239468 | Mar 2022 → Sep 2025 | primary biliary cholangitis | Intercept Pharmaceuticals | Completed | Mixed |
| Phase 2 | NCT04594694 | Oct 2019 → Oct 2025 | primary biliary cholangitis | Intercept Pharmaceuticals | Terminated | Mixed Stop: Business |
| Phase 2 | NCT02430077 | Jun 2016 → Oct 2022 | familial partial lipodystrophy | Abhimanyu Garg | Completed | No outcome recorded |
| Phase 2 | NCT02633956 | Dec 2015 → Mar 2017 | metabolic dysfunction-associated steatohepatitis | Intercept Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT05321524 | Jul 2015 → Mar 2023 | biliary atresia | Intercept Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02177136 | Feb 2015 → Mar 2017 | primary sclerosing cholangitis | Intercept Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT02039219 | Nov 2014 → Jul 2017 | alcoholic hepatitis | Naga P. Chalasani | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT01865812 | Dec 2013 → Aug 2014 | primary biliary cholangitis | Intercept Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01585025 | Apr 2012 → Jan 2014 | bile acid malabsorption, primary, 1, chronic diarrheal disease, disorder of metabolite absorption and transport | Imperial College Healthcare NHS Trust | Completed | Met primary |
| Phase 2 | NCT00570765 | Jan 2008 → Sep 2010 | cirrhosis of liver | Intercept Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00550862 | Oct 2007 → Aug 2009 | cirrhosis of liver | Intercept Pharmaceuticals | Terminated | Met primary |
| Phase 37 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT06691412 | Nov 2024 → Jan 2026 overdue | chronic hepatitis B virus infection, fatty liver disease | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06488911 | Jul 2024 → Oct 2025 | primary biliary cholangitis | Intercept Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05450887 | Sep 2021 → Mar 2024 | primary biliary cholangitis | Nanjing Chia-tai Tianqing Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT04956328 | Jul 2021 → Sep 2023 | primary biliary cholangitis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT03439254 | Aug 2017 → Sep 2022 | cirrhosis of liver, metabolic dysfunction-associated steatohepatitis | Intercept Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT02548351 | Sep 2015 → Sep 2023 | metabolic dysfunction-associated steatohepatitis | Intercept Pharmaceuticals | Terminated | Met primary |
| Phase 3 | NCT01473524 | Jan 2012 → Dec 2013 | primary biliary cholangitis | Intercept Pharmaceuticals | Completed | Met primary |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT03633227 | Jun 2018 → Jul 2021 | cirrhosis of liver | Intercept Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT02308111 | Dec 2014 → Dec 2021 | cirrhosis of liver | Intercept Pharmaceuticals | Terminated | Missed primary Stop: Enrollment |
| Phase not applicable3 trials | ||||||
| — | NCT05740631 | Aug 2022 → Jul 2023 | — | Universitaire Ziekenhuizen KU Leuven | Unknown | No outcome recorded |
| — | NCT03836937 | Mar 2019 → Nov 2020 | NAFLD1 | Sir Salimullah Medical College Mitford Hospital | Completed | No outcome recorded |
| — | NCT02654236 | Apr 2016 → Sep 2019 | alcohol-related disorders | Suthat Liangpunsakul | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 0 | NCT03253276 Comparator | May 2016 → Sep 2018 | primary biliary cholangitis | University of Aarhus | Completed | No outcome recorded |
| Phase 1 | NCT02532335 Comparator | Aug 2015 → Dec 2020 | obesity disorder | Sahlgrenska University Hospital | Unknown | No outcome recorded |
| 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 2/3 | NCT06121375 Comparator | Sep 2024 → Oct 2025 | biliary atresia | Intercept Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2024-11-27 | Advanz Pharma | Regulatory ADVANZ PHARMA’s response to the reversal of the suspension of the European Commission decision on the OCALIVA® conditional marketing authorisation in Europe advanzpharma.com ↗
This means that the EC’s revocation decision is in force, resulting in the CMA for OCALIVA® being revoked in Europe (EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway) with immediate effect. |
| 2024-09-05 | Advanz Pharma | Regulatory ADVANZ PHARMA secures temporary suspension of the European Commission decision on the OCALIVA® conditional marketing authorisation in Europe advanzpharma.com ↗
The European Commission’s decision to revoke the OCALIVA® conditional marketing authorisation has been suspended with immediate effect by Order of the President of the General Court of the European Union |
| 2024-09-03 | Advanz Pharma | Regulatory ADVANZ PHARMA’s response to European Commission revocation of conditional marketing authorisation for OCALIVA® in rare disease Primary Biliary Cholangitis (PBC) advanzpharma.com ↗
today announces that the European Commission (EC) has revoked the conditional marketing authorisation (CMA) of OCALIVA® (obeticholic acid) in Europe for second-line treatment of patients with the rare disease Primary Biliary Cholangitis (PBC). |
| 2024-07-01 | Advanz Pharma | Regulatory ADVANZ PHARMA response to CHMP recommendation pertaining to EU conditional marketing authorization for OCALIVA® in rare disease Primary Biliary Cholangitis advanzpharma.com ↗
ADVANZ PHARMA Holdco Limited (“ADVANZ PHARMA” or “the Company”), a UK headquartered pharmaceutical company, acknowledges that the Committee for Medicinal Products for Human Use (“CHMP”) has recommended the European Commission should revoke the EU conditional marketing authorisation of OCALIVA® for 2nd line use in patients with the rare disease Primary Biliary Cholangitis (PBC). |
| 2023-05-31 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Obeticholic Acid Tablets lupin.com ↗ |
| 2023-03-23 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Obeticholic Acid Tablets lupin.com ↗ |
All press releases naming this drug 8 releases
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 ↗ |
| 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 ↗ |