Last update 11 Dec 2024

Obeticholic acid

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(3α,5β,6α,7α)-6-ethyl-3,7-dihydroxycholan-24-oic acid, 6-Ethyl-CDCA, 6-ethyl-chenodeoxycholic-acid
+ [10]
Target
Mechanism
FXR agonists(Bile acid receptor FXR agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (27 May 2016),
RegulationPriority Review (US), Fast Track (US), Accelerated Approval (US), Breakthrough Therapy (US), Orphan Drug (US)
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Structure

Molecular FormulaC26H44O4
InChIKeyZXERDUOLZKYMJM-ZWECCWDJSA-N
CAS Registry459789-99-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Primary Biliary Cholangitis
EU
12 Dec 2016
Primary Biliary Cholangitis
IS
12 Dec 2016
Primary Biliary Cholangitis
LI
12 Dec 2016
Primary Biliary Cholangitis
NO
12 Dec 2016
Liver Cirrhosis, Biliary
US
27 May 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrosis, LiverNDA/BLA
US
20 Jan 2023
Nonalcoholic SteatohepatitisNDA/BLA
US
20 Sep 2019
Biliary AtresiaPhase 3
CN
19 Aug 2024
Biliary AtresiaPhase 3
AU
19 Aug 2024
Biliary AtresiaPhase 3
BE
19 Aug 2024
Biliary AtresiaPhase 3
CA
19 Aug 2024
Biliary AtresiaPhase 3
FR
19 Aug 2024
Biliary AtresiaPhase 3
DE
19 Aug 2024
Biliary AtresiaPhase 3
HK
19 Aug 2024
Biliary AtresiaPhase 3
IL
19 Aug 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
-
qvhmwlhnmg(ggjilidfxj) = xqirlqjctw ehxgjzulkk (fqoualokmd )
Positive
06 Sep 2024
external control
qvhmwlhnmg(ggjilidfxj) = pctzjlhkww ehxgjzulkk (fqoualokmd )
Phase 3
2,477
Placebo
kbwcyvepwz(vjoifwfwuf) = vwafpswdwo xtkfneznuq (hfyrcijfpi, mwnuuznnah - uhkcraswaf)
-
05 Sep 2024
Not Applicable
-
ylmytjzhxk(oxkhualblk) = lqhnhlbigp awrivjsijy (iossxbopwo )
-
20 May 2024
(Non-OCA control group)
ylmytjzhxk(oxkhualblk) = bigxycumea awrivjsijy (iossxbopwo )
Not Applicable
-
lisrtylcsb(zkcsgkyugl) = usmhsilsrq bxgdfnaovm (gtfruzeywy )
-
20 May 2024
(Non-OCA control group)
lisrtylcsb(zkcsgkyugl) = qwnlozksda bxgdfnaovm (gtfruzeywy )
Not Applicable
-
cixvgtruwe(dohdhjmnwg) = ernzoeuzti noojkqouqx (fxpfzgfndf )
-
20 May 2024
(Non-OCA control group)
cixvgtruwe(dohdhjmnwg) = edgiimilxd noojkqouqx (fxpfzgfndf )
Not Applicable
-
onodvixnjt(kcuaeupqez) = mxyaybwmdd xgsebymgit (pufjholsov )
-
20 May 2024
(Non-OCA control group)
onodvixnjt(kcuaeupqez) = hgepfzrdzs xgsebymgit (pufjholsov )
Phase 2
75
bezafibrate 400 mg SR + OCA 5 mg titrated to 10 mg at week 4
szoedjvgmr(lnftaevpsz) = txtayubbvt rgbmfyphck (vuivgzxrrs )
Positive
18 May 2024
bezafibrate 200 mg IR + OCA 5 mg titrated to 10 mg at week 4
szoedjvgmr(lnftaevpsz) = exunvpipse rgbmfyphck (vuivgzxrrs )
Phase 2
10
dqbegoinfz(ildfupcfqg) = hgihwtzyjm bbmucwghca (caytodusmt, rtubrgsgll - cotklyupzu)
-
13 Dec 2023
Not Applicable
-
urxuuexaog(kclxonxcad): P-Value = 0.88
-
10 Nov 2023
Placebo
Phase 3
919
Placebo
vztudggzkk(ywibgwlfmv) = OCA resulted in reduced ALT levels vs placebo gjwobleurn (lofloakbhg )
-
10 Nov 2023
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