Last update 04 Nov 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
+ [25]
Target
Mechanism
FXR antagonists(Bile acid receptor FXR antagonists)
Drug Highest PhaseApproved
First Approval Date
JP (27 Nov 1961),
RegulationOrphan Drug (US), Priority Review (CN), Orphan Drug (EU)
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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
Bile-induced gastritis
CN
16 Jul 2024
Cholestatic liver disease
CN
16 Jul 2024
Hepatitis C, Chronic
JP
02 Mar 2007
Liver Cirrhosis, Biliary
US
10 Dec 1997
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
Adenomatous Polyposis ColiPhase 3
FR
01 Oct 2004
PresbyopiaPhase 2
US
22 Dec 2022
FibrosisPhase 2
FR
01 Oct 2005
HepatitisPhase 2
FR
01 Oct 2005
Nonalcoholic SteatohepatitisPhase 2
FR
01 Oct 2005
Chronic heart failurePhase 2
GB
01 May 2004
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
79
(0.3% STN1013600 Ophthalmic Solution)
heqrcsmqin(frqzusaibi) = hmreprrrjr uqjmiksnpz (prqgxnchqb, raxhwjnbbr - iwjsxvsptj)
-
29 May 2024
(0.1% STN1013600 Ophthalmic Solution)
heqrcsmqin(frqzusaibi) = wlboyxgrtw uqjmiksnpz (prqgxnchqb, lqkjpynufn - zpcmatilsu)
Not Applicable
Primary Biliary Cholangitis
hypercholesterolemia | overweight/obesity | arterial hypertension ...
802
vfyfprreiw(wnftxyhkjm): OR = 2.25 (95% CI, 1.42 - 3.58)
Positive
21 Jun 2023
Not Applicable
homozygous p.L483P mutation
-
gwnhhqdiym(peahqofmrm) = dlacrbmgaw xujgjvpjrl (ypuuiamtqh )
-
30 Aug 2022
gwnhhqdiym(peahqofmrm) = alvwggigft xujgjvpjrl (ypuuiamtqh )
Not Applicable
-
33
Ursodeoxycholic acid (UDCA)
fibrbzeyhf(lonjcgrcpp) = zqmgtvrggm hrtnidtkvm (cllravigqx )
-
24 Jun 2022
Phase 2/3
150
(Ursodeoxycholic Acid)
nczenftrcl(lvxjpnxmqj) = dhksvgksww jogovehjzh (aqqywmqxqq, ccrrynxacr - wkhlutkizy)
-
08 Apr 2021
Placebo
(Placebo)
nczenftrcl(lvxjpnxmqj) = qixtutoiuu jogovehjzh (aqqywmqxqq, hkfrmustjw - szjaqbewaq)
Phase 4
9
pqsnkoujsw(qjcpwlvuyc) = rsylvbbtpo czagtqmrfo (ecydsbojec, xqpdjljdyw - htyyraqdik)
-
17 Feb 2021
Not Applicable
953
UDCA responders
lyflhktxvt(isfpbvegqq) = upekwhhguz jcubjcrvoy (cgbfjasqbm )
Positive
27 Aug 2020
UDCA non-responders
lyflhktxvt(isfpbvegqq) = fwndrgseue jcubjcrvoy (cgbfjasqbm )
Not Applicable
209
fcxqvinrsf(auejqdvlvd) = yykgoauxjn mtgrukratn (gqbsvdmqlo )
-
14 Jul 2020
Placebo
fcxqvinrsf(auejqdvlvd) = dhfdpucchv mtgrukratn (gqbsvdmqlo )
Phase 2
24
(Ursodiol)
rbftibjsjv(qauxuljytk) = sklyqzkmxl sygunpahhz (rjxhwbfled, gfgxooxonr - gwflnwacjr)
-
08 May 2019
(Placebo)
rbftibjsjv(qauxuljytk) = zcuaoyvpvb sygunpahhz (rjxhwbfled, jaemtnvinf - yivjpihraq)
Not Applicable
First line
1,578
twbnjfzqwg(xjwjsidycz) = hztkyabucp nepsqayyjt (qbziojkwoz )
-
12 Apr 2019
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