Drugs / Ursodeoxycholic Acid
Ursodeoxycholic Acid
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | URSO 250 | — | 2004-07-21 | fda.gov ↗ |
| Label expansion | US (FDA) | ACTIGALL | — | 1996-03-29 | fda.gov ↗ |
| Approved | US (FDA) | ACTIGALL | — | 1987-12-31 | fda.gov ↗ |
Trials 86 · started per year
today
US approved 1987
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06884748 | May 2026 → May 2027 expected | Clostridium difficile colitis | Medical College of Wisconsin | Not yet recruiting | No outcome recorded |
| Phase 114 trials · 2 met primary | ||||||
| Phase 1 | NCT02967250 | Apr 2020 → Feb 2022 | Parkinson disease | University of Minnesota | Completed | No outcome recorded |
| Phase 1 | NCT03512821 | Oct → Nov 2017 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03512808 | Jun → Jul 2017 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03000218 | Aug 2016 → Jun 2017 | obesity disorder | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT02789644 | May → Jul 2016 | — | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT02622685 | May 2015 → Feb 2016 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT02385032 | Feb → Mar 2015 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT01088607 | Oct 2010 → Dec 2016 | primary sclerosing cholangitis | University of Tennessee | Completed | No outcome recorded |
| Phase 1 | NCT00873275 | Mar 2009 → Sep 2012 | colorectal cancer | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00514774 | Aug 2007 → Jun 2009 | Huntington disease | Oregon Health and Science University | Unknown | No outcome recorded |
| Phase 1 | NCT00529009 | May 2007 → ? | — | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 1 | NCT00909610 | Dec 2006 → Jan 2007 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00909753 | Sep → Oct 2006 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00857480 | Jun → Aug 2006 | cirrhosis of liver | Norgine | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05659654 | Dec 2022 → Mar 2023 | COVID-19 | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 1/2 | NCT03516006 | Jan 2017 → Jan 2019 | primary sclerosing cholangitis | Fuzhou General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT02965911 | Jan 2016 → Sep 2021 | primary biliary cholangitis | Beijing 302 Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 218 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT07378761 | Jun 2026 → Jan 2028 expected | liver disorder | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 2 | NCT07672860 | Jun → Oct 2026 expected | kidney cancer | Jinling Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06842472 | Feb 2025 → Dec 2028 expected | breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05467553 | Feb 2023 → Feb 2025 | hepatitis D virus infection | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04834557 | Nov 2021 → May 2022 | rheumatoid arthritis | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT03840005 | Dec 2018 → May 2021 | Parkinson disease | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT03602976 | Aug 2018 → Jan 2022 | — | Ethan Weinberg | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02244944 | Sep 2014 → Sep 2015 | NAFLD1 | Gregory Graf, PhD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01899703 | Mar 2014 → Oct 2015 | intrahepatic cholestasis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02021110 | Dec 2013 → Oct 2015 | autosomal dominant polycystic kidney disease, liver disorder | Radboud University Medical Center | Completed | Missed primary |
| Phase 2 | NCT02033876 | Oct 2013 → Jan 2017 | type 2 diabetes mellitus | Mayo Clinic | Completed | Missed primary |
| Phase 2 | NCT01688375 | Dec 2012 → Jul 2013 | obstructive jaundice | University Clinical Centre of Kosova | Unknown | No outcome recorded |
| Phase 2 | NCT02016365 | Feb 2012 → Dec 2014 | cardiomyopathy | Umeå University | Completed | No outcome recorded |
| Phase 2 | NCT01097304 | Apr 2010 → Apr 2014 | Barrett esophagus, carcinoma of esophagus | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01149304 | Jun 2009 → Nov 2017 | metastasis from malignant tumor of colon, radiation-induced disorder | University of Magdeburg | Completed | Met primary |
| Phase 2 | NCT00470171 | Oct 2005 → Nov 2008 | — | Axcan Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00285597 | May 2004 → Jan 2006 | congestive heart failure | National Heart and Lung Institute | Unknown | Met primary |
| Phase 2 | NCT00004315 | Nov 1995 → ? | cholestasis, cystic fibrosis | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Phase 2/36 trials · 2 missed | ||||||
| Phase 2/3 | NCT03724175 | Aug 2019 → Mar 2026 | pouchitis, ulcerative colitis | Stanford University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT06365424 | Apr 2017 → Apr 2027 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 2/3 | NCT00808743 | May 2009 → Jul 2011 | classic familial adenomatous polyposis, intestinal polyp, tumor of duodenum | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT00846963 | Oct 2008 → Dec 2012 | cholestasis | Ibrahim Mohamed | Completed | No outcome recorded |
| Phase 2/3 | NCT00134758 | Oct 2004 → Jun 2009 | classic or attenuated familial adenomatous polyposis | Assistance Publique - Hôpitaux de Paris | Unknown | Missed primary |
| Phase 2/3 | NCT00059202 | Jul 2002 → Jun 2008 | primary sclerosing cholangitis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | Missed primary |
| Phase 38 trials · 1 met primary | ||||||
| Phase 3 | NCT06294847 | Aug 2024 → May 2027 expected | rhegmatogenous retinal detachment | Hopital Foch | Recruiting | No outcome recorded |
| Phase 3 | NCT05416580 | Sep 2022 → Mar 2024 | type 2 diabetes mellitus | University of Banja Luka | Unknown | No outcome recorded |
| Phase 3 | NCT06127355 | Mar 2021 → Feb 2022 | gestational diabetes | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | Completed | No outcome recorded |
| Phase 3 | NCT02823353 | Apr 2016 → May 2022 | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Completed | Met primary |
| Phase 3 | NCT02721862 | Mar 2016 → Sep 2018 | cholelithiasis | American University of Beirut Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT01226823 | Nov 2010 → Nov 2013 | intrahepatic cholestasis of pregnancy | University of Bologna | Withdrawn | No outcome recorded |
| Phase 3 | NCT00706381 | Jun 2008 → Aug 2012 | — | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Mixed |
| Phase 3 | NCT00200343 | Jul 2002 → Dec 2004 | chronic hepatitis C virus infection | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 418 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT06610760 | Nov 2024 → Oct 2026 expected | gastric intestinal metaplasia | Yongquan Shi | Recruiting | No outcome recorded |
| Phase 4 | NCT06517862 | Sep 2024 → Mar 2026 | hyperbilirubinemia | Amira Adel Fouly | Completed | No outcome recorded |
| Phase 4 | NCT06918080 | Nov 2023 → May 2025 overdue | NAFLD1, acute lymphoblastic leukemia, obesity disorder | Ain Shams University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05690646 | Jan → Mar 2023 | — | China National Center for Cardiovascular Diseases | Unknown | No outcome recorded |
| Phase 4 | NCT05410535 | Sep 2021 → Oct 2022 | gastric cancer | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 4 | NCT04407650 | Jul 2021 → Dec 2024 overdue | gestational diabetes | King's College London | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04910178 | Dec 2020 → Dec 2021 | NAFLD1, type 2 diabetes mellitus | Asmaa Abdelfattah Elsayed | Completed | No outcome recorded |
| Phase 4 | NCT04650243 | Jan 2020 → May 2025 overdue | primary biliary cholangitis | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT02748616 | Mar 2017 → Nov 2019 | diarrheal disease | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT02338635 | Jul 2015 → Jan 2017 | end stage renal failure | Ewha Womans University | Unknown | No outcome recorded |
| Phase 4 | NCT02472509 | Dec 2014 → Sep 2017 | gallstones, hemolytic anemia | Shaare Zedek Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02340247 | Nov 2014 → Apr 2015 | obesity disorder | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02415777 | Oct 2014 → Jul 2015 | — | Daewoong Pharmaceutical Co. LTD. | Completed | Met primary |
| Phase 4 | NCT02418130 | Oct 2014 → Mar 2015 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 4 | NCT01974336 | Jan 2013 → Apr 2016 | short bowel syndrome | Jinling Hospital, China | Completed | No outcome recorded |
| Phase 4 | NCT01510860 | Nov 2008 → Jul 2010 | primary biliary cholangitis | Dr. Falk Pharma GmbH | Completed | No outcome recorded |
| Phase 4 | NCT01141322 | Aug 2007 → Apr 2010 | hepatitis | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT00161083 | Nov 2001 → Nov 2004 | cholecystolithiasis | UMC Utrecht | Completed | Missed primary |
| Phase not applicable18 trials · 2 met primary | ||||||
| — | NCT07664020 | Jun 2026 → Nov 2027 expected | liver disorder | Institute of Liver and Biliary Sciences, India | Not yet recruiting | No outcome recorded |
| — | NCT07525401 | Apr → Oct 2026 expected | hepatitis A virus infection, hepatitis E virus infection | Combined Military Hospital, Pakistan | Not yet recruiting | No outcome recorded |
| — | NCT07867366 | Feb → Jul 2026 | hyperbilirubinemia | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT07273734 | Jan 2026 → Jun 2027 expected | hepatic encephalopathy | West China Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07102979 | Sep → Dec 2025 overdue | cirrhosis of liver | Chang Gung Memorial Hospital | Enrolling by invitation | No outcome recorded |
| — | NCT07110987 | Jun 2025 → Jan 2027 expected | — | Tishreen University Hospital | Recruiting | No outcome recorded |
| — | NCT06684106 | Nov 2024 → Nov 2026 expected | glucose intolerance, hyperlipidemia | First Affiliated Hospital Xi'an Jiaotong University | Recruiting | No outcome recorded |
| — | NCT06091787 | Sep 2023 → Nov 2024 | — | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT04937023 | Jun → Dec 2021 | bone remodeling disease | SVS Institute of Dental Sciences | Unknown | No outcome recorded |
| — | NCT05043194 | Jan → Sep 2021 | parenteral nutrition-associated cholestasis | Wei Liu | Unknown | No outcome recorded |
| — | NCT05526807 | May 2019 → Dec 2023 | Clostridium difficile colitis | Nottingham University Hospitals NHS Trust | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT03664596 | Aug 2018 → Sep 2020 | metabolic dysfunction-associated steatohepatitis | Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan | Completed | Met primary |
| — | NCT03489889 | Dec 2016 → Dec 2017 | primary biliary cholangitis | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| — | NCT02936596 | Dec 2016 → Jun 2022 | autoimmune hepatitis, cholangitis, cholestasis, cirrhosis of liver | Xiaoli Fan | Unknown | No outcome recorded |
| — | NCT02319629 | Dec 2014 → Dec 2018 | morbid obesity | HaEmek Medical Center, Israel | Unknown | Met primary |
| — | NCT00858858 | Mar 2009 → Mar 2013 | gastroesophageal reflux disease | US Department of Veterans Affairs | Completed | No outcome recorded |
| — | NCT00004441 | Sep 1997 → Sep 2001 | cystic fibrosis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| — | NCT00004442 | ? → Apr 1999 | Zellweger spectrum disorders, adrenoleukodystrophy, d-bifunctional protein deficiency | University of Cincinnati | Terminated | No outcome recorded |
| Comparator or background therapy61 trials | ||||||
| Phase 0 | NCT06591455 Comparator | Sep 2024 → Aug 2025 | primary biliary cholangitis | Han Ying | Completed | No outcome recorded |
| Phase 1 | NCT05832697 Comparator | Jan 2022 → Jan 2023 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03201952 Comparator | Feb 2018 → May 2020 | glucose intolerance | Vanderbilt University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02841306 Comparator | Jul 2016 → Sep 2017 | rhegmatogenous retinal detachment | Francine Behar-Cohen | Completed | No outcome recorded |
| Phase 1 | NCT01440309 Comparator | Nov 2011 → Nov 2013 | primary biliary cholangitis | Robert Chunhua Zhao, MD, PhD | Unknown | No outcome recorded |
| Phase 1/2 | NCT07795151 Background | Aug 2026 → Aug 2029 expected | primary biliary cholangitis | Beijing 302 Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT02651350 Background | Dec 2015 → Jul 2019 | drug-induced liver injury | Beijing 302 Hospital | Completed | Met primary |
| Phase 1/2 | NCT01483248 Comparator | Oct 2010 → Oct 2013 | cirrhosis of liver | S-Evans Biosciences Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT00990639 Background | Sep 2005 → Dec 2008 | alcoholic liver disease | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT05973370 Comparator | May → Nov 2023 | rheumatoid arthritis | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT04810156 Comparator | Apr 2021 → Apr 2025 | drug-induced hepatitis | Inge Marie Svane | Unknown | No outcome recorded |
| Phase 2 | NCT03678480 Comparator | Mar → Oct 2021 | primary sclerosing cholangitis | HighTide Biopharma Pty Ltd | Withdrawn | No outcome recorded |
| Phase 2 | NCT02943707 Background | Oct 2016 → Oct 2017 | liver disorder | Wenzhou Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT02420496 Comparator | Jun 2016 | cholestasis, liver disorder | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded |
| Phase 2 | NCT01904058 Background | Aug 2013 → Apr 2015 | primary biliary cholangitis | Mirum Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 2 | NCT00550862 Background | Oct 2007 → Aug 2009 | cirrhosis of liver | Intercept Pharmaceuticals | Terminated | Met primary |
| Phase 2 | NCT00062023 Comparator | Jun 2003 → Apr 2005 | colorectal cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2/3 | NCT07852780 Comparator | Oct 2026 → Oct 2027 expected | infectious disease with sepsis | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06591468 Comparator | Oct 2024 → Dec 2027 expected | primary biliary cholangitis | Han Ying | Enrolling by invitation | No outcome recorded |
| Phase 2/3 | NCT06174402 Background | Aug 2023 → Jul 2026 overdue | primary biliary cholangitis | Han Ying | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05902468 Comparator | Jun 2023 → Jun 2024 | type 2 diabetes mellitus | Tanta University | Unknown | No outcome recorded |
| Phase 2/3 | NCT05749822 Background | Feb 2023 → Dec 2027 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04542473 Comparator | Jul 2021 → Oct 2023 | infectious disease with sepsis, protein-energy malnutrition | University of Oxford | Unknown | No outcome recorded |
| Phase 2/3 | NCT05500937 Comparator | Mar 2021 → Dec 2023 | diabetes mellitus | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 2/3 | NCT03056274 Comparator | Jan → Jun 2019 | intrahepatic cholestasis of pregnancy, pregnancy disorder | Epsom and St Helier University Hospitals NHS Trust | Unknown | No outcome recorded |
| Phase 3 | NCT07296458 Comparator | Dec 2025 → Dec 2028 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT06443606 Background | Mar 2025 → Dec 2027 expected | — | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT06755541 Background | Jan 2024 → Dec 2035 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT05751967 Background | Feb 2023 → Dec 2027 expected | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT04924868 Comparator | Nov 2021 → Jul 2027 expected | acute pancreatitis | Hospital General Universitario de Alicante | Recruiting | No outcome recorded |
| Phase 3 | NCT06715319 Background | Oct 2021 → Oct 2023 | primary biliary cholangitis | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05450887 Background | Sep 2021 → Mar 2024 | primary biliary cholangitis | Nanjing Chia-tai Tianqing Pharmaceutical | Completed | No outcome recorded |
| Phase 3 | NCT04956328 Background | Jul 2021 → Sep 2023 | primary biliary cholangitis | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04309773 Background | Apr 2021 → Mar 2023 | cholestasis, primary sclerosing cholangitis | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 3 | NCT04751188 Background | Oct 2020 → Jun 2021 | primary biliary cholangitis | Mexican Social Security Institute | Unknown | No outcome recorded |
| Phase 3 | NCT02937012 Background | Oct 2016 → Apr 2019 | primary biliary cholangitis | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Unknown | No outcome recorded |
| Phase 3 | NCT02916290 Background | Jan 2016 → Dec 2018 | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Unknown | No outcome recorded |
| Phase 3 | NCT02823366 Background | Jan 2016 → Dec 2023 | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Unknown | No outcome recorded |
| Phase 3 | NCT02916641 Background | Jan 2016 → Dec 2018 | primary biliary cholangitis | Xijing Hospital of Digestive Diseases | Unknown | No outcome recorded |
| Phase 3 | NCT01857284 Comparator | Sep 2009 → Jan 2013 | primary biliary cholangitis | Beijing Friendship Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01829698 Comparator | Aug 2009 → Jan 2013 | cholestasis | Beijing Trendful Kangjian Medical Information Consulting Limited Company | Completed | No outcome recorded |
| Phase 3 | NCT00746486 Background | Feb 2009 → Oct 2019 | primary biliary cholangitis | Dr. Falk Pharma GmbH | Terminated | Missed primary |
| Phase 3 | NCT01576458 Comparator | Jan → Dec 1998 | intrahepatic cholestasis, pregnancy disorder | Turku University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00004784 Background | Jan 1994 → ? | cirrhosis of liver | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 3 | NCT00004748 Background | Nov 1989 → ? | cirrhosis of liver | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 4 | NCT05849558 Comparator | Feb 2022 → Dec 2023 | liver disorder | MinaPharm Pharmaceuticals | Unknown | No outcome recorded |
| Phase 4 | NCT04618575 Background | Mar 2021 → Nov 2022 | autoimmune disease, hepatitis, primary biliary cholangitis | West China Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04786795 Comparator | Mar 2021 → Feb 2022 | postcholecystectomy syndrome | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT04617561 Comparator | Nov 2020 → Nov 2022 | autoimmune hepatitis, primary biliary cholangitis | West China Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04977661 Comparator | Feb → May 2020 | metabolic dysfunction-associated steatohepatitis | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 4 | NCT01337440 Comparator | Apr 2010 → Mar 2013 | liver disorder, type 2 diabetes mellitus | Kanazawa University | Unknown | No outcome recorded |
| Phase 4 | NCT00042549 Background | May 2002 → ? | cholelithiasis | Medstone International | Terminated | No outcome recorded |
| — | NCT06922669 Background | Jun 2025 → Mar 2027 expected | drug-induced liver injury | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| — | NCT07068191 Comparator | Jun → Jul 2025 overdue | NAFLD1, alcoholic fatty liver disease | Phenomen Pharma | Recruiting | No outcome recorded |
| — | NCT05925309 Background | Jul 2023 → Dec 2027 expected | biliary atresia, cholangitis | Children's Hospital of Fudan University | Recruiting | No outcome recorded |
| — | NCT03665519 Background | Jan 2018 → Sep 2020 | primary biliary cholangitis | National Scientific Medical Center, Kazakhstan | Completed | No outcome recorded |
| — | NCT03659058 Comparator | Mar 2016 → Aug 2018 | fibrotic liver disease | Zagazig University | Completed | No outcome recorded |
| — | NCT03247101 Comparator | Feb 2016 → Dec 2017 | gallstones | Min-Sheng General Hospital | Unknown | Met primary |
| — | NCT01505569 Background | Oct 2011 → Feb 2024 | Ewing sarcoma, atypical teratoid rhabdoid tumor, germ cell tumor, hepatoblastoma +6 | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| — | NCT01548079 Comparator | Oct 2008 → Nov 2009 | NAFLD1, morbid obesity | Sahlgrenska University Hospital | Completed | No outcome recorded |
| — | NCT01073202 Comparator | May 2005 → Apr 2008 | cholestasis, ischemic disease | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2020-10-18 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives Final Approval from USFDA for Ursodiol Capsules and Tentative Approval for Linagliptin and Metformin Hydrochloride Tablets zyduslife.com ↗
Zydus Cadila has received final approval from the USFDA to market Ursodiol Capsules USP, 300 mg (US RLD: Actigall ®Capsules). |
| 2020-06-19 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Ursa Published in a SCI Journal for Efficacy in the Prevention of Gallstone Formation daewoong.co.kr ↗
The findings showed higher effects on gallstone prevention in the Ursa 300-mg and 600-mg groups than the placebo group. |
| 2009-05-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval And Launch Of Generic Urso 250® And Urso Forte® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Ursodiol Tablets USP, 250 mg and 500 mg. |
| 2008-12-16 | Lannett Company, Inc. | Regulatory Lannett Company Receives FDA Approval For Ursodiol 300 MG CapsulesPDF Version investorroom.com ↗
Lannett Company, Inc. (AMEX: LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ursodiol 300 mg Capsules, the generic equivalent of Actigall® marketed by Watson Pharmaceuticals. |
| 2007-09-11 | Daewoong Pharmaceutical Co. LTD. | Regulatory UDCA’s Efficacy in Improvement of Liver Functions of Chronic Hepatitis C Patients Acknowledged daewoong.co.kr ↗
Ursodeoxycholic acid, the active ingredient of Ursa, was recently acknowledged for its efficacy in the improvement of liver functions of chronic hepatitis C patients by Japan’s Ministry of Health and Welfare. |
All press releases naming this drug 6 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 160 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ursodeoxycholic acid | “The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs....” NCT00746486 ↗118“Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption,...” NCT00004441 ↗ “The aim of this study is to explore the potential of Ursodeoxycholic acid (UDCA) to slow down the progression of Parkinson's Disease (PD) in a randomised, double-blind,...” NCT03840005 ↗ “Ursodeoxycholic acid (UDCA) exerts anticholestatic, antifibrotic and antiproliferative effects in primary biliary cirrhosis (PBC) via mechanisms not yet fully understood.” PMID 22414767 ↗ Mar 2012 “Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb).” NCT00004315 ↗ “Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations.” NCT02823353 ↗ “Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1” NCT00857480 ↗ “Ursodeoxycholic acid (UDCA), as the first BA used in humans, improves glucose and lipid metabolism and attenuates oxidative stress.” PMID 38455850 ↗ Feb 2024 “Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)” NCT04956328 ↗ “Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations.” NCT02916290 ↗ “Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations.” NCT02916641 ↗ |
| Known as | Actigall | “Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb).” NCT00004315 ↗ |
| Known as | UCD | “Daily doses of Ursodeoxycholic acid (UCD) Ursofalk) in a dose of 20 mg/Kg/day in two divided doses depending on their body weight for 12 weeks will be assigned to arm(1)” NCT06918080 ↗ |
| Known as | UDCA | “Hypothesis: The bile acid, ursodeoxycholic acid (UDCA) in delayed (ileocolonic)-release formulation, stimulates bile acid membrane receptor (TGR-5) and farnesol X (FXR)...” NCT02033876 ↗69“In patients with primary biliary cholangitis (PBC), the efficacy of budesonide, a synthetic corticosteroid displaying high first-pass metabolism, is unresolved. In a...” PMID 32950590 ↗ Sep 2020 “High field - 7 tesla (T) - magnetic resonance spectroscopy (MRS) is able to non-invasively assess for changes in brain energetics and will be used to evaluate the effects that...” NCT02967250 ↗ “The goal of this open label randomized trial is to understand the role of oral ursodeoxycholic acid(UDCA) supplementation in the liver regeneration (in terms of liver function...” NCT06091787 ↗ “Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption,...” NCT00004441 ↗ “Ursodeoxycholic acid (UDCA) is very safe drug which is used to dissolve gallstones, but its role in preventing biliary complications after ABP has not been studied adequately...” NCT04924868 ↗ “Primary biliary cholangitis (PBC) is a rare autoimmune liver disease and the first line available treatment is ursodeoxycholic acid (UDCA), however, direct and indirect...” PMID 32758152 ↗ Aug 2020 “The goal of this clinical trial is to learn if ursodeoxycholic acid, also called UDCA, can help protect kidney function in adults undergoing partial nephrectomy for kidney tumors.” NCT07672860 ↗ “Ursodeoxycholic acid (UDCA) inhibits proliferation of polycystic human cholangiocytes in vitro and hepatic cystogenesis in a rat model of polycystic liver disease (PLD) in vivo.” PMID 27212247 ↗ May 2016 “All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an addon treatment to the current DMARDs treatments for rheumatoid arthritis.” NCT05973370 ↗ “The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).” NCT01576458 ↗ |
| Known as | Ursacol | “One of the products and ursodeoxycholic acid, commercially known as Ursacol, a bile acid physiologically present in human bile, approved by Agência Nacional de Vigilância...” NCT03489889 ↗ |
| Known as | URSO | “Ursodeoxycholic Acid (URSO)” NCT06842472 ↗ |
| Known as | Ursocarb | “Patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (Actigall) and buffered, enteric-coated ursodiol (Ursocarb).” NCT00004315 ↗ |
| Known as | ursodeoxycholate acid | “Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC” NCT01857284 ↗ |
| Known as | ursodesoxycholic acid | “The aim of this study was to evaluate the impact of ursodesoxycholic acid (UDCA) on duodenal adenoma formation in patients with FAP.” PMID 21899713 ↗ Jul 2012 |
| Known as | ursodiol | “Ursodeoxycholic acid (UDCA), or ursodiol, is a bile acid commonly used to manage cholestatic liver disease.” NCT06517862 ↗24“Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day” NCT02244944 ↗ |
| Known as | Ursofalk | “ursodeoxycholic acid capsules (Ursofalk, 250 mg/capsules), starting with oral administration of pharmacologic doses of 20-25mg/kg/d, twice daily, until they were discharged .” NCT05043194 ↗1“Daily doses of Ursodeoxycholic acid (UCD) Ursofalk) in a dose of 20 mg/Kg/day in two divided doses depending on their body weight for 12 weeks will be assigned to arm(1)” NCT06918080 ↗ |
| Known as | Ursolvan | “oral administration of ursodeoxycholic acid (Ursolvan®)” NCT06294847 ↗ |
| Action | Activate | “UDCA activated Nrf2 signaling to increase GPX1 and catalase expression” PMID 24852569 ↗ May 2014 |
| Modality | Small molecule | “the secondary bile acid ursodeoxycholic acid (UDCA)” NCT04834557 ↗ |
| Route | Oral | “Patients are randomized to receive either TUDCA or ursodiol orally for an initial 3 month period” NCT00004441 ↗ |