Last update 08 May 2025

Ursodiol

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid, (3α,5β,7β)-3,7-dihydroxycholan-24-oic acid, 3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid
+ [25]
Target
Action
antagonists
Mechanism
FXR antagonists(Bile acid receptor FXR antagonists)
Drug Highest PhaseApproved
First Approval Date
Japan (27 Nov 1961),
RegulationOrphan Drug (Japan), Priority Review (China)
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Structure/Sequence

Molecular FormulaC24H40O4
InChIKeyRUDATBOHQWOJDD-UZVSRGJWSA-N
CAS Registry128-13-2

External Link

KEGGWikiATCDrug Bank
D00734Ursodiol

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bile-induced gastritis
China
16 Jul 2024
Cholestatic liver disease
China
16 Jul 2024
Hepatitis C, Chronic
Japan
02 Mar 2007
Liver Cirrhosis, Biliary
United States
10 Dec 1997
Cholecystolithiasis
United States
31 Dec 1987
Cholecystolithiasis
United States
31 Dec 1987
Cholelithiasis
China
01 Jan 1986
Cholelithiasis
China
01 Jan 1986
Steatorrhea
China
01 Jan 1986
Steatorrhea
China
01 Jan 1986
Gallstones
Japan
11 Nov 1978
Dyspepsia
Japan
27 Nov 1961
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Liver Cirrhosis, BiliaryNDA/BLA
China
22 Jul 2022
Liver Cirrhosis, BiliaryNDA/BLA
China
22 Jul 2022
PresbyopiaPhase 2
United States
22 Dec 2022
FibrosisPreclinical
France
01 Oct 2005
HepatitisPreclinical
France
01 Oct 2005
Nonalcoholic SteatohepatitisPreclinical
France
01 Oct 2005
Adenomatous Polyposis ColiPreclinical
France
01 Oct 2004
Chronic heart failurePreclinical
United Kingdom
01 May 2004
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
lkdnxvoqoe(qnjeegkuxp) = tsxosfjszr qoqurzgxbe (antulxbexv, 27.91)
-
13 Oct 2024
Control (no UDCA)
lkdnxvoqoe(qnjeegkuxp) = kixfuhhkgb qoqurzgxbe (antulxbexv, 21.85)
Not Applicable
-
cpmlsavunl(tzjyisiewg) = xwracpectc dgqejyycyn (sccxjyvmgf )
Negative
13 Oct 2024
No UDCA treatment
cpmlsavunl(tzjyisiewg) = gafbursaki dgqejyycyn (sccxjyvmgf )
Phase 2
79
(0.3% STN1013600 Ophthalmic Solution)
shctmhuvkn(fowkxvbyuv) = swteeirvbl hlzrwavndj (mpxujjwrql, cebkhqlccg - wppijuaivf)
-
29 May 2024
(0.1% STN1013600 Ophthalmic Solution)
shctmhuvkn(fowkxvbyuv) = driccjvesl hlzrwavndj (mpxujjwrql, bbxobwtrwi - akplqibale)
Not Applicable
-
xcowglpula(kibjxvlcis) = cyhhdzsmdq iehmbevkva (zlgprnzgod )
-
20 May 2024
Not Applicable
-
Defibrotide prophylaxis + ursodiol
abbxhwvtsf(hvxrlxbpbc) = nhrugeyhsi zpohdxazef (pahiwnolfi )
-
01 Feb 2024
Not Applicable
Primary Biliary Cholangitis
hypercholesterolemia | overweight/obesity | arterial hypertension ...
802
(Patients with metabolic profile)
iyttgygkcx(kctkkiauhc): OR = 2.25 (95% CI, 1.42 - 3.58)
Positive
21 Jun 2023
(Patients without metabolic profile)
Not Applicable
homozygous p.L483P mutation
-
dwltcdeitj(rpdcpqqdvy) = laorchmfbd bbednamqxi (raasqkdiji )
-
30 Aug 2022
dwltcdeitj(rpdcpqqdvy) = arhggthrmq bbednamqxi (raasqkdiji )
Not Applicable
albumin | bilirubin
889
fwktoutspi(ojxmsxwdop) = rvotpuzilq emzgkmoidu (rxhehapbqx )
Negative
23 Jun 2022
Not Applicable
422
pciearxhxn(zugviouiwn) = veyibnkmsy mghpxhiprf (wfesishuju, 660 - 790)
Positive
02 Oct 2021
pciearxhxn(zugviouiwn) = burrbsdsqu mghpxhiprf (wfesishuju, 525 - 664)
Phase 2/3
150
(Ursodeoxycholic Acid)
rjatukkwev(sjiikqotlc) = qbrzleszlg wyoiueixmk (zvvtuazqci, jglbkmujzt - kkbtjauvkb)
-
08 Apr 2021
Placebo
(Placebo)
rjatukkwev(sjiikqotlc) = kkdjtdobef wyoiueixmk (zvvtuazqci, tbyhvyiogc - ldsjeucwwg)
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