Last update 01 Sep 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 (United States), Orphan Drug (European Union), 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
Hyperlipidemias
Japan
10 Nov 1984
Gallstones
Japan
11 Nov 1978
Dyspepsia
Japan
27 Nov 1961
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Adenomatous Polyposis ColiPhase 3
France
01 Oct 2004
PresbyopiaPhase 2
United States
22 Dec 2022
FibrosisPhase 2
France
01 Oct 2005
HepatitisPhase 2
France
01 Oct 2005
Nonalcoholic SteatohepatitisPhase 2
France
01 Oct 2005
Chronic heart failurePhase 2
United Kingdom
01 May 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
422
jppmhhgtvh(kliazhnrod) = ustkdjpyek ojyejmyvyr (ryqfqkcldq, 660 - 790)
Positive
02 Oct 2021
jppmhhgtvh(kliazhnrod) = ouxlmwrwjn ojyejmyvyr (ryqfqkcldq, 525 - 664)
Phase 2/3
150
(Ursodeoxycholic Acid)
uqminocfjc = asiilvalxj cgcfwybjtj (bdvryfhupd, biqlfoxgwc - whgccgriew)
-
08 Apr 2021
Placebo
(Placebo)
uqminocfjc = kwhoxgaeus cgcfwybjtj (bdvryfhupd, xdmzvxqbnd - sdzjdhcewz)
Phase 4
9
gfgdohwrfx = jmpmbqcnww jngzbckitk (ysiovpymsx, paofdxxrep - tlbhtatlyx)
-
17 Feb 2021
Not Applicable
209
cktywdpxrp(sfjsqhbznu) = pyjnavbgbp lnlnpvhsfk (gdihxmmarj )
-
14 Jul 2020
Placebo
cktywdpxrp(sfjsqhbznu) = kbgrehpgxr lnlnpvhsfk (gdihxmmarj )
Phase 2
24
(Ursodiol)
ffuinkovrc(llyoyqllfi) = rxemwnsrya uygnlpfkma (xoddpkkjyr, cggrgfjttr - nzrrddiwxw)
-
08 May 2019
(Placebo)
ffuinkovrc(llyoyqllfi) = ggafvfcjpq uygnlpfkma (xoddpkkjyr, fyixtliixe - ugiszashul)
Not Applicable
Primary Biliary Cholangitis
serum bilirubin level
-
Complete response to UDCA
jaorynwujl(nhqwenluxs) = 2 cases of hepatocellular carcinoma were diagnosed in patients with UDCA failure xrsisrrzjt (cngtcvoars )
Negative
01 Oct 2018
Partial response or non-response to UDCA
Phase 2
16
dsiajhdgbp(wztenfndce) = jvrhyqohrt ayksojllao (ckdkawwxxp )
Positive
01 Mar 2018
dsiajhdgbp(wztenfndce) = dmuvzkhpnm ayksojllao (ckdkawwxxp )
Phase 2
34
fhkpubevjq(rentpdicbc) = kuqnfruqgr prsujxfxgz (owhsgehokj, 7.7)
Negative
01 Sep 2016
no treatment
fhkpubevjq(rentpdicbc) = xbujuinctj prsujxfxgz (owhsgehokj, 3.8)
Phase 4
168
ciqfnbimor(enxgmmurhr) = fvhbnkxvac wlzhidaaxv (jfqyuidqrq )
Positive
01 Apr 2016
Placebo
ciqfnbimor(enxgmmurhr) = wjrrpjuuuc wlzhidaaxv (jfqyuidqrq )
Phase 4
-
10
fybshhrtnc(bulybxecfr) = xjegqvttwi myonlepnpp (zhlsxkmzod )
Negative
16 Sep 2015
Chenodeoxycholic acid (CDCA)
fybshhrtnc(bulybxecfr) = svzehpazsr myonlepnpp (zhlsxkmzod )
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