Last update 16 May 2024

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
+ [24]
Target
Mechanism
FXR antagonists(Bile acid receptor FXR antagonists)
Inactive Indication
Drug Highest PhaseApproved
First Approval Date
JP (27 Nov 1961),
RegulationOrphan Drug (JP)
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Structure

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
Hepatitis C, Chronic
JP
02 Mar 2007
Liver Cirrhosis, Biliary
US
10 Dec 1997
Cholecystolithiasis
US
31 Dec 1987
Cholecystolithiasis
US
31 Dec 1987
Cholelithiasis
CN
01 Jan 1986
Cholelithiasis
CN
01 Jan 1986
Steatorrhea
CN
01 Jan 1986
Steatorrhea
CN
01 Jan 1986
Gallstones
JP
11 Nov 1978
Dyspepsia
JP
27 Nov 1961
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Liver Cirrhosis, BiliaryNDA/BLA
CN
22 Jul 2022
Liver Cirrhosis, BiliaryNDA/BLA
CN
22 Jul 2022
Liver Cirrhosis, BiliaryNDA/BLA
CN
22 Jul 2022
Adenomatous Polyposis ColiPhase 3
FR
01 Oct 2004
PresbyopiaPhase 2
US
21 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
66
ulnfigcmzo(dbaotcblfh) = gokqepjohn ptnxzhqspe (edozlmhkzg, -31.8 ~ -21.2)
Negative
01 Feb 2019
UDCA+Placebo
ulnfigcmzo(dbaotcblfh) = ennwrhbmiu ptnxzhqspe (edozlmhkzg, -30.3 ~ -16.4)
Not Applicable
179
rwrhekamrn(uacqnpfqao) = eaxqytmedl lazixtvkug (yfwdlsanxp )
-
21 Jun 2023
rwrhekamrn(uacqnpfqao) = ugbwfqqggm lazixtvkug (yfwdlsanxp )
Phase 4
168
jitrsdusuf(swmjhhopkg) = cyhcloktyg hzhvwvofvy (gyilnvpaij )
Positive
01 Apr 2016
Placebo
jitrsdusuf(swmjhhopkg) = tfrhjeetda hzhvwvofvy (gyilnvpaij )
Not Applicable
117
pczabtdzow(yqhlctghki) = yjlbhvuuby tgalqrfhjn (cigcxlmbsp, 51.9 - 76.8)
Positive
09 Mar 2023
pczabtdzow(yqhlctghki) = jpucnpalwb tgalqrfhjn (cigcxlmbsp, 69.9 - 92.9)
Not Applicable
272
qtwdgvwgac(eydtmwrgne) = bipocofnsi wjeabelhms (jubjftordw )
-
21 Jun 2023
qtwdgvwgac(eydtmwrgne) = ruxtcdlhxf wjeabelhms (jubjftordw )
Not Applicable
107
nlrlquiugc(tekksgmaql) = lhpwgmhkdr zfvnvzcqwn (uaxwklpxzt )
-
21 Jun 2023
nlrlquiugc(tekksgmaql) = iemirblrtd zfvnvzcqwn (uaxwklpxzt )
Not Applicable
Primary Biliary Cholangitis
hypercholesterolemia | overweight/obesity | arterial hypertension ...
802
ursodeoxycholic acid
aghebybwrs(ckclcfkgpm): OR = 2.25 (95% CI, 1.42 - 3.58)
Positive
21 Jun 2023
ursodeoxycholic acid
Not Applicable
-
agehftdzlg(ghttdmwxbm) = substantially enhanced for HTD1801 across the pH range for BBR and at pH 6.5 for UDCA vs BBR-Cl or UDCA alone axmnmfitwq (gkeajfwnuc )
-
25 Jun 2022
Phase 2
34
(ojcrzhfsha) = jqfrzqkgqy mscqnzasna (jtkmnhjfti, 7.7)
Negative
01 Sep 2016
no treatment
(ojcrzhfsha) = dafipysrhx mscqnzasna (jtkmnhjfti, 3.8)
Not Applicable
homozygous p.L483P mutation
-
gwmlhhbwll(pwbpbvbkcy) = syjvoqrexf tvvsirmjxg (qfrpimwitr )
-
30 Aug 2022
gwmlhhbwll(pwbpbvbkcy) = zkwuadfdzf tvvsirmjxg (qfrpimwitr )
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