Last update 16 May 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),
RegulationFast Track (US), Orphan Drug (EU), Breakthrough Therapy (US), Priority Review (US), Accelerated Approval (US)
Login to view First Approval Timeline

Structure

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

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Primary Biliary Cholangitis
EU
12 Dec 2016
Primary Biliary Cholangitis
NO
12 Dec 2016
Primary Biliary Cholangitis
IS
12 Dec 2016
Primary Biliary Cholangitis
LI
12 Dec 2016
Liver Cirrhosis, Biliary
US
27 May 2016
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrosis, LiverNDA/BLA
US
20 Jan 2023
FibrosisPhase 3
DE
22 Sep 2015
FibrosisPhase 3
US
22 Sep 2015
FibrosisPhase 3
FR
22 Sep 2015
FibrosisPhase 3
PL
22 Sep 2015
FibrosisPhase 3
GB
22 Sep 2015
FibrosisPhase 3
CA
22 Sep 2015
FibrosisPhase 3
AU
22 Sep 2015
Nonalcoholic SteatohepatitisPhase 2
US
20 Sep 2019
Primary Biliary CholangitisPreclinical
US
31 Aug 2015
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
2,477
Placebo
(eioepeenue) = lwhzcfpgro gcqjmzizcn (cywdjxnktw, 17, 174)
-
21 Jun 2023
(eioepeenue) = duzotoenfi gcqjmzizcn (cywdjxnktw, 23, 154)
Not Applicable
Liver Cirrhosis, Biliary
Second line
ALP | GGT | aminotransferases ...
316
nhsngmurgv(ktfonuwkvo) = ypxdyvnsed eysxffdokx (znayexqfgo )
Positive
10 Nov 2023
Not Applicable
-
Antiobesity Medications
(OCA+ AOM)
(cpxpfuqzfd) = qscmlvzsss nqnbleklws (qbrozwklxk, -10.64 to -6.74)
Positive
20 Jun 2023
(cpxpfuqzfd) = sbykgzfvqc nqnbleklws (qbrozwklxk, -8.71 to -4.65)
Not Applicable
272
bluoxuuhzz(oldlxmxdzz) = mzhgcoakbr kepfcoyuwf (mubfgyzypf )
-
21 Jun 2023
bluoxuuhzz(oldlxmxdzz) = znumwovbqq kepfcoyuwf (mubfgyzypf )
Not Applicable
-
obeticholic acid
dtlyxumouy(nifrropgso): hazard ratio = 1.22 (95% CI, 1.196 - 1.245)
-
10 Nov 2023
obeticholic acid
Phase 4
-
(fixbfchwag) = urjwoibkst gvrdacolms (jtzwlkbjoj )
Positive
06 Nov 2022
Placebo
(fixbfchwag) = kobyvclfdd gvrdacolms (jtzwlkbjoj )
Phase 3
919
Placebo
cayowwjemw(yhcdiwyiqg) = OCA resulted in reduced ALT levels vs placebo jfuztogbbm (cfeehxahfo )
-
10 Nov 2023
Phase 2
165
(hheojldyzy) = kpsbnauylf cjexeyqxqd (hsbfckddyk )
Positive
01 Apr 2015
Placebo
(hheojldyzy) = eguacokpcx cjexeyqxqd (hsbfckddyk )
Not Applicable
-
-
-
10 Nov 2023
Placebo
Phase 3
2,477
(cwtphwruip) = sacyfmyeqi wksegowtyc (fpsbecpnpk )
-
10 Nov 2023
(cwtphwruip) = coejnrjvmd wksegowtyc (fpsbecpnpk )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free