Taurursodiol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | RELYVRIO | — | 2022-09-29 | fda.gov ↗ |
Trials 29
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04727320 | Mar → Jul 2021 | cirrhosis of liver | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT04001647 | Jun 2019 → Aug 2022 | arterial disorder, isoproterenol-mediated vasodilatation | Colorado State University | Terminated | No outcome recorded |
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT04114292 | Jan 2019 → Jun 2022 | ulcerative colitis | Washington University School of Medicine | Completed | Met primary |
| Phase 1 | NCT03878654 | Jan → Sep 2019 | asthma | University of Vermont | Terminated | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06025630 | Aug 2023 → Dec 2028 expected | hypertensive disorder | University of North Texas Health Science Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04987671 | Aug 2021 → May 2022 | amyotrophic lateral sclerosis | Amylyx Pharmaceuticals Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT03423121 | Jun 2018 → Apr 2022 | chronic progressive multiple sclerosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1/2 | NCT01855360 | Jun 2013 → May 2015 | amyloidosis | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07699380 | Sep 2026 → Dec 2029 expected | type 1 diabetes mellitus | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT07517276 | Apr → May 2026 overdue | metabolic dysfunction-associated steatotic liver disease | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07328009 | Jan 2026 → Jan 2029 expected | hepatocellular carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07100392 | Aug 2025 → Aug 2027 expected | hepatocellular carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07064668 | Jul 2025 → Jun 2027 expected | hepatocellular carcinoma | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04244630 | Nov 2023 → Jul 2026 overdue | amyotrophic lateral sclerosis | Dallas VA Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03488524 | Mar 2018 → Mar 2021 | amyotrophic lateral sclerosis | Amylyx Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02218619 | Aug 2015 → Dec 2019 | type 1 diabetes mellitus | Robin Goland, MD | Completed | No outcome recorded |
| Phase 2 | NCT01171859 | Jul 2010 → Apr 2015 | hereditary amyloidosis | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
| Phase 2 | NCT00877604 | Jun 2008 → Jul 2011 | amyotrophic lateral sclerosis | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04516096 | Nov 2020 → Dec 2022 | amyotrophic lateral sclerosis | Amylyx Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT05619783 | Dec 2022 → Oct 2024 | amyotrophic lateral sclerosis | Amylyx Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05753852 | Oct 2021 → Mar 2025 | amyotrophic lateral sclerosis | Humanitas Mirasole SpA | Unknown | No outcome recorded |
| Phase 3 | NCT03800524 | Feb 2019 → Dec 2023 | amyotrophic lateral sclerosis | Humanitas Mirasole SpA | Unknown | No outcome recorded |
| Phase 3 | NCT03481972 | Apr 2018 → Jan 2023 | amyloidosis | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
| Phase 3 | NCT01857284 | Sep 2009 → Jan 2013 | primary biliary cholangitis | Beijing Friendship Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01829698 | Aug 2009 → Jan 2013 | cholestasis | Beijing Trendful Kangjian Medical Information Consulting Limited Company | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06827873 | Feb → May 2025 overdue | — | Tsinghua University | Not yet recruiting | No outcome recorded |
| — | NCT00771901 | Feb 2008 → Dec 2014 | obesity disorder, type 2 diabetes mellitus | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00004410 | Jun 1998 → Mar 2002 | cholestasis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| — | NCT00004441 | Sep 1997 → Sep 2001 | cystic fibrosis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT03533257 Comparator | Sep 2018 → Oct 2020 | Alzheimer disease | Amylyx Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01998451 Background | Dec 2012 → Dec 2018 | gallstones | The First Affiliated Hospital of Guangzhou Medical University | Unknown | No outcome recorded |
| — | NCT01877551 Comparator | Sep 2013 → May 2018 | — | Washington University School of Medicine | Completed | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | taurursodiol | “Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO, also known as Ursodoxicoltaurine or Tauroursodeoxycholic Acid [TUDCA])” NCT03488524 ↗5“Over-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses” NCT04244630 ↗ “AMX0035 twice daily--a combination of Sodium Phenylbutyrate (3g) and Taurursodiol (1g)” NCT03533257 ↗ “oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo” NCT07699380 ↗ “Fixed dose combination of Sodium Phenylbutyrate and taurursodiol.” NCT04987671 ↗ “Combination of 3 g phenylbutyrate and 1 g taurursodiol” NCT05619783 ↗ |
| Known as | tauroursodeoxycholate | “The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA” NCT01857284 ↗ |
| Known as | Tauroursodeoxycholic Acid | “Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile acid, acts as a chemical chaperone to reduce protein aggregation and colitis severity in preclinical models.” PMID 40236400 ↗ Apr 202526“Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO, also known as Ursodoxicoltaurine or Tauroursodeoxycholic Acid [TUDCA])” NCT03488524 ↗ “Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal” NCT01829698 ↗ “Oral Double Wood brand TUDCA (Tauroursodeoxycholic Acid) dietary supplement capsules, dosage 1000 mg/person/day.” NCT06827873 ↗ “the chemical chaperone tauroursodeoxycholic acid (TUDCA), an established inhibitor of ER stress” NCT04001647 ↗ “Tauroursodeoxycholic Acid and Sodium Phenylbutyrate orally given twice a day” NCT04516096 ↗ “Tauroursodeoxycholic Acid (TUDCA): 250 mg orally twice daily.” NCT07328009 ↗ “TUDCA (Tauroursodeoxycholic Acid) Supplementation” NCT07064668 ↗ “tauroursodeoxycholic acid (TUDCA; 1,750 mg/day)” NCT06025630 ↗ |
| Known as | Tauroursodeoxycholic Acid [TUDCA] | “Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO; also known as Tauroursodeoxycholic Acid [TUDCA])” NCT03533257 ↗ |
| Known as | Tauroursodesoxycholic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL272427 ↗ |
| Known as | Taurursodiol component of relyvrio | ChEMBL registry synonym — accepted as the source's own label CHEMBL272427 ↗ |
| Known as | TUDCA | “Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile acid, acts as a chemical chaperone to reduce protein aggregation and colitis severity in preclinical models.” PMID 40236400 ↗ Apr 202514“Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease.” NCT00004441 ↗ “Given all of this information, the investigators propose that a specific bile acid called tauroursodeoxycholic acid (TUDCA) may be helpful in patients with asthma.” NCT03878654 ↗ “Tauroursodeoxycholic acid (TUDCA) is a hydrophilic bile acid that is produced in the liver and used for treatment of chronic cholestatic liver diseases.” PMID 25664595 ↗ Feb 2015 “Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO, also known as Ursodoxicoltaurine or Tauroursodeoxycholic Acid [TUDCA])” NCT03488524 ↗ “Half of the participants will receive the bile acid tauroursodeoxycholic acid (TUDCA) and half will receive placebo.” NCT03423121 ↗ “the chemical chaperone tauroursodeoxycholic acid (TUDCA), an established inhibitor of ER stress” NCT04001647 ↗ “The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA” NCT01857284 ↗ “infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin” NCT00004410 ↗ “Tauroursodeoxycholic Acid (TUDCA): 250 mg orally twice daily.” NCT07328009 ↗ “tauroursodeoxycholic acid (TUDCA).” NCT03481972 ↗ |
| Known as | TURSO | “Sodium phenylbutyrate and taurursodiol (PB and TURSO) is hypothesized to mitigate endoplasmic reticulum stress and mitochondrial dysfunction, two of many mechanisms implicated...” PMID 39131742 ↗ Aug 20241“Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO, also known as Ursodoxicoltaurine or Tauroursodeoxycholic Acid [TUDCA])” NCT03488524 ↗ |
| Known as | Ur-906 | ChEMBL registry synonym — accepted as the source's own label CHEMBL272427 ↗ |
| Known as | Ursodeoxycholyltaurine | ChEMBL registry synonym — accepted as the source's own label CHEMBL272427 ↗ |
| Known as | Ursodoxicoltaurine | “Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO, also known as Ursodoxicoltaurine or Tauroursodeoxycholic Acid [TUDCA])” NCT03488524 ↗ |
| Action | Inhibit | “the chemical chaperone tauroursodeoxycholic acid (TUDCA), an established inhibitor of ER stress” NCT04001647 ↗ |
| Modality | Small molecule | “Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt” NCT01877551 ↗ |
| Route | Oral | “TUDCA is administered by mouth” NCT00004410 ↗ |