In this study, the investigators aimed to evaluate the hepatoprotective effect of OCA against HBV-induced liver injury by comparing patients demographic , laboratory date ( liver function , viremia ) , degree of hepatic steatosis and fibrosis and portal doppler at the beginning and after six months .

Start Date15 Nov 2024

Sponsor / Collaborator

Assiut University

NCT06121375 / RecruitingPhase 2/3

A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Obeticholic Acid Compared to Placebo in Pediatric Subjects With Biliary Atresia, Post-hepatoportoenterostomy

This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy). The double-blind period comprises of 2 phases: dose titration phase and age expansion treatment phase.

Start Date02 Sep 2024

Sponsor / Collaborator

Intercept Pharmaceuticals, Inc.

NCT06488911 / Enrolling by invitationPhase 3

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).

Start Date01 Jul 2024

Sponsor / Collaborator

Intercept Pharmaceuticals, Inc.

100 Clinical Results associated with Obeticholic acid

100 Translational Medicine associated with Obeticholic acid

100 Patents (Medical) associated with Obeticholic acid

1,408

Literatures (Medical) associated with Obeticholic acid

31 Dec 2024·Renal Failure

Obeticholic acid ameliorates sepsis-induced renal mitochondrial damage by inhibiting the NF-κb signaling pathway

Article

Author: Qin, Da ; Lin, Jin ; Li, Tian ; Jing, Danyang ; Liu, Jingfeng ; Duan, Meili ; Li, Yu

Acute kidney injury (AKI), a common complication of sepsis, might be caused by overactivated inflammation, mitochondrial damage, and oxidative stress. However, the mechanisms underlying sepsis-induced AKI (SAKI) have not been fully elucidated, and there is a lack of effective therapies for AKI. To this end, this study aimed to investigate whether obeticholic acid (OCA) has a renoprotective effect on SAKI and to explore its mechanism of action. Through bioinformatics analysis, our study confirmed that the mitochondria might be a critical target for the treatment of SAKI. Thus, a septic rat model was established by cecal ligation puncture (CLP) surgery. Our results showed an evoked inflammatory response via the NF-κB signaling pathway and NLRP3 inflammasome activation in septic rats, which led to mitochondrial damage and oxidative stress. OCA, an Farnesoid X Receptor (FXR) agonist, has shown anti-inflammatory effects in numerous studies. However, the effects of OCA on SAKI remain unclear. In this study, we revealed that pretreatment with OCA can inhibit the inflammatory response by reducing the synthesis of proinflammatory factors (such as IL-1β and NLRP3) via blocking NF-κB and alleviating mitochondrial damage and oxidative stress in the septic rat model. Overall, this study provides insight into the excessive inflammation-induced SAKI caused by mitochondrial damage and evidence for the potential use of OCA in SAKI treatment.

01 Dec 2024·Bioorganic Chemistry

Design, synthesis and FXR partial agonistic activity of anthranilic acid derivatives bearing aryloxy moiety as therapeutic agents for metabolic dysfunction-associated steatohepatitis

Article

Author: Tu, Jiaojiao ; Zhang, Bing ; Chen, Cong ; Li, Xin ; Yu, Qiming ; Cheng, Wa ; Duan, Xiaoqun ; Meng, Jieyun ; Tan, Xiangduan ; Peng, Yanfen ; Zhou, Xianghui

Farnesoid X receptor (FXR) is considered a promising therapeutic target for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Increasing evidence suggests that targeting FXR with full agonists may lead to side effects. FXR partial agonists, which moderately activate FXR signaling, are emerging as a feasible approach to mitigate side effects and address MASH. Herein, a series of novel anthranilic acid derivatives bearing aryloxy moiety were designed and synthesized using a hybrid strategy from the previously identified FXR partial agonists DM175 and AIV-25. Particularly, compound 26 exhibited potent FXR partial agonistic activity in a dual-luciferase reporter gene assay with an EC₅₀ value of 0.09 ± 0.02 µM (75.13 % maximum efficacy relative to OCA). In the MASH mice model, compound 26 significantly ameliorated the pathological features of the liver, including steatosis, inflammation, and fibrosis. In addition, compound 26 displayed high selectivity, good oral bioavailability, high liver distribution, as well as an acceptable safety profile. Molecular simulation studies showed that compound 26 fitted well with the binding site of FXR. Collectively, these findings demonstrated that compound 26 might serve as a promising candidate targeting FXR for MASH treatment.

01 Dec 2024·International Immunopharmacology

New Insights on the potential therapeutic effects of glibenclamide and Obeticholic acid against Alloxan-Induced diabetes mellitus in rat model

Article

Author: Saad, Hebatallah M ; Aboushouk, Asmaa A ; Gad El-Karim, Dina R S ; Rohiem, Aya H

Diabetes mellitus (DM) represents a highly prevalent metabolic disorder across the globe. This study aimed to determine the ameliorative efficacy of glibenclamide (Gli) and obeticholic acid (OCA) against biochemical and pathological changes related to alloxan-induced diabetes. Twenty male Wistar rats were allocated into four groups; Control group, Diabetic group: received intraperitoneal injection of alloxan (120 mg/kg) for induction of diabetes, Diabetic + Gli group: Diabetic rats treated daily with oral Gli (5 mg/kg) and Diabetic + OCA group: Diabetic rats treated daily with oral OCA (10 mg/kg). All rats were subjected to 30 days treatments. Our results indicated that Gli successfully ameliorated hyperglycemia and dyslipidemia with a significant decline in serum pancreatic lipase activity and increased insulin level, while OCA had the same effect but without any enhancement in serum insulin levels. Additionally, the disturbances in liver function-related parameters and the evoked oxidative stress, interleukin(IL)-6 and IL-10 in the liver and pancreas were abrogated upon treatment with Gli and OCA. Furthermore, Gli and OCA increased AMP-activated protein kinase (P-AMPK), insulin receptor substrate 1 (IRS1), farnesoid X receptor (FXR), and glucagon-like peptide-1 receptor (GLP-1R) expressions and downregulated sterol regulatory element binding protein-1c mRNA expression. Besides, Gli and OCA have alleviated diabetes-induced histopathological distortions in hepatic and pancreatic tissues and enhanced the immunoexpression of insulin, and proliferating cell nuclear antigen with decreased immune reactivity of glucagon within pancreatic tissues. Gli and OCA decreased the immune reactivity of nuclear factor kappa B and increased the glycogen content of hepatic tissues. In conclusion, OCA is efficacious in the management of dyslipidemia and hyperglycemia of DM and its related oxidative stress.

180

News (Medical) associated with Obeticholic acid

14 Nov 2024

·www.businesswire.com

Mirum Pharmaceuticals to Showcase Data from its LIVMARLI and Volixibat Clinical Programs at AASLD’s The Liver Meeting

FOSTER CITY, Calif.--( BUSINESS WIRE )--Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will present data at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting®, taking place November 15-19, 2024, in San Diego, California. Enclosed below are the titles that have been accepted for presentation during the meeting. The abstracts are available via the AASLD website . Full analyses will be available following their presentation within the Publications & Presentation section on Mirum’s website . Presentations Abstract #5038: Volixibat for Cholestatic Pruritus in Primary Biliary Cholangitis: An Adaptive, Randomized, Placebo-controlled Phase 2b Trial (VANTAGE): Interim Results **Late-breaker poster presentation** Monday, November 18 from 1:00-2:00pm, Poster Hall C Presented by Dr. Kris Kowdley, Washington State University, Seattle, Washington, USA Abstract #184: Improvements in Pruritus are Associated with Improvements in Growth in Patients with Progressive Familial Intrahepatic Cholestasis: Data from the MARCH-ON trial **Oral presentation** Sunday, November 17 from 12:15-12:30pm during the ‘Advances in Pediatric Liver Disease’ session, Ballroom 6C Presented by Dr. Alexander Miethke, Cincinnati Children’s Hospital, Cincinnati, Ohio, USA Abstract #4347: Pilot Study of Volixibat Co-administered with OCA for Primary Biliary Cholangitis (PBC) Treatment: The VLX-602 Trial Monday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall C Presented by Dr. Kris Kowdley, Washington State University, Seattle, Washington, USA Abstract #4400: Impact of Maralixibat on Caregiver Burden for Patients with Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis Monday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall C Presented by Dr. Natasha Dilwali, The Johns Hopkins School of Medicine, Baltimore, Maryland, USA Abstract #4419 : Real-world Use of Maralixibat in Biliary Atresia: A Case Series Monday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall C Presented by Dr. Natasha Dilwali, The Johns Hopkins School of Medicine, Baltimore, Maryland, USA Abstract #4432: The Relationship Between Serum Bile Acids and Event-Free Survival Following the Use of Maralixibat for Progressive Familial Intrahepatic Cholestasis: Data from MARCH/MARCH-ON Monday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall C Presented by Professor Richard Thompson, King’s College London, United Kingdom Abstract #4436: Bile Acid Subspecies are Correlated with Pruritus and Bilirubin Improvement in PFIC Patients Treated with Maralixibat: Data from MARCH and MARCH-ON Monday, November 18 from 1:00-2:00pm during Poster Session IV, Poster Hall C Presented by Professor Henkjan Verkade, University of Groningen, Groningen, Netherlands Alagille Syndrome Patient & Physician Fireside Discussion During the meeting, Mirum will host a session spotlighting a pediatric hepatologist and an adult patient living with ALGS. Dr. Ajay Jain, St. Louis University, will discuss clinical insights and patient, Emma, will share her experience with LIVMARLI. Sunday, November 17 from 1:30-2:00 p.m. in Exhibit Hall TLM Theater #2 About LIVMARLI® (maralixibat) oral solution LIVMARLI® (maralixibat) oral solution is an orally administered, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for two pediatric cholestatic liver diseases. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. three months of age and older and in Europe for patients two months of age and older. It is also approved in the U.S. for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) 12 months of age and older and in Europe for the treatment of PFIC in patients three months of age and older. For more information for U.S. residents, please visit LIVMARLI.com . LIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS and PFIC. To learn more about ongoing clinical trials with LIVMARLI, please visit Mirum’s clinical trials section on the company’s website. IMPORTANT SAFETY INFORMATION Limitation of Use : LIVMARLI is not for use in PFIC type 2 patients who have a severe defect in the bile salt export pump (BSEP) protein. LIVMARLI can cause side effects, including: Liver injury . Changes in certain liver tests are common in patients with Alagille syndrome and PFIC but can worsen during treatment. These changes may be a sign of liver injury. In PFIC, this can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including nausea or vomiting, skin or the white part of the eye turns yellow, dark or brown urine, pain on the right side of the stomach (abdomen), bloating in your stomach area, loss of appetite or bleeding or bruising more easily than normal. Stomach and intestinal (gastrointestinal) problems. LIVMARLI can cause stomach and intestinal problems, including diarrhea and stomach pain. Your healthcare provider may advise you to monitor for new or worsening stomach problems including stomach pain, diarrhea, blood in your stool or vomiting. Tell your healthcare provider right away if you have any of these symptoms more often or more severely than normal for you. A condition called Fat Soluble Vitamin (FSV) Deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat is common in patients with Alagille syndrome and PFIC but may worsen during treatment. Your healthcare provider should do blood tests before starting and during treatment and may monitor for bone fractures and bleeding which have been reported as common side effects. US Prescribing Information EU SmPC Canadian Product Monograph About Mirum Pharmaceuticals, Inc. Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum has three approved medications: LIVMARLI® (maralixibat) oral solution , CHOLBAM® (cholic acid) capsules, and CHENODAL® (chenodiol) tablets. LIVMARLI, an IBAT inhibitor, is approved for the treatment of two rare liver diseases affecting children and adults. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the U.S. (three months and older), in Europe (two months and older), and in other regions globally. It is also approved in the U.S. in cholestatic pruritus in PFIC patients 12 months of age and older; in Europe, it is approved for patients with PFIC three months of age and older. Mirum is also initiating the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms or liver disease. CHENODAL has received medical necessity recognition by the FDA to treat patients with cerebrotendinous xanthomatosis (CTX). Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases. Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2 VISTAS study for primary sclerosing cholangitis (PSC) and Phase 2b VANTAGE study for primary biliary cholangitis. Volixibat has been granted Breakthrough Therapy Designation for the treatment of cholestatic pruritus in patients with PBC. Lastly, chenodiol, has been evaluated in a Phase 3 clinical study, RESTORE, to treat patients with CTX, with positive topline results reported in 2023. Mirum has submitted a new drug application with the FDA for the approval of chenodiol to treat CTX in the U.S. To learn more about Mirum, visit mirumpharma.com and follow Mirum on Facebook , LinkedIn , Instagram and Twitter (X). Forward-Looking Statements This press release includes forward-looking statements pertaining to the Company’s planned participation at a scientific conference, including data presentation title and synopsis for both commercial and clinical programs, which may include discussion of the Company’s clinical and research data relating to the therapeutic potential and/or commercial viability of LIVMARLI or other Company product candidates in various liver disease indications and in patient populations that are investigational only. Words such as “will,” “could,” “would,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general and the other risks described in Mirum’s filings with the Securities and Exchange Commission. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. A further description of risks and uncertainties can be found in Mirum’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov .

Phase 2Breakthrough TherapyDrug ApprovalOrphan DrugPhase 3

13 Nov 2024

·www.echemi.com

FDA Rejects Approval for Liver Disease Drug, Market Outlook Grim

The U.S. Food and Drug Administration (FDA) made an important decision on Tuesday, denying full approval of Intercept Pharmaceuticals' liver disease drug. The decision raises questions about the drug's future market prospects. Still, Intercept Pharmaceuticals said that despite the FDA's denial of full approval, their drug Ocaliva will continue to receive accelerated approval in the United States. Under the accelerated approval pathway, the FDA requires additional trials to verify a drug's benefits. If data from these trials do not prove a drug's effectiveness, regulators can require companies to withdraw the drug from the market. Ocaliva received accelerated FDA approval in 2016 to treat patients with primary cholangitis. Primary cholangitis is a rare disease that causes inflammation of the small bile ducts in the liver and eventually destroys them. Because of the rarity of the disease, recruiting patients for confirmatory trials has become very difficult. According to the American Liver Foundation, fewer than 200,000 cases of primary cholangitis are recorded in the United States each year. Intercept Pharmaceuticals said it will continue to submit safety data on the drug to health regulators. The FDA's decision is in line with recommendations made by an independent panel of experts in September. The panel said the available data did not definitively prove the drug's effectiveness or dispel doubts about its safety. "I think the future of this drug is now very much up to the applicants and potential patients who will participate in the new trial," Julia Wattacheril, an assistant professor at Columbia University's Wagelow Snake School of Surgery, said before the FDA decision. She also added that it is unclear whether there is the will to devote more resources to gathering further data on the drug. Ocaliva and ursodecylcholic acid were among the first treatments. Since then, several other drugs, including Gileads Livdeizi, have been made available to patients. In June, the European drug regulator revoked Ocaliva's conditional authorization, saying its efficacy had not been proven.

Accelerated Approval

13 Nov 2024

·www.pharmaceutical-technology.com

Intercept loses Ocaliva FDA full approval bid in rare liver disease

The FDA decision comes in the wake of a negative AdCom opinion in September. Image credit: Shutterstock/ Dilok Klaisataporn. On the heels of an unfavourable advisory committee (AdCom) meeting, the US Food and Drug Administration (FDA) has decided not to approve Intercept Pharmaceutical’s Ocaliva (obeticholic acid) for primary biliary cholangitis (PBC). The agency issuing a complete response letter means the US pharma company’s bid to turn Ocaliva’s accelerated approval into full approval has come up short. The drug will continue to be available for patients with the liver disease in the US under the accelerated approval granted in 2016, as per a 12 November press release. The FDA said it was “unable to approve the supplemental new drug application (sNDA) in its current form”, which tallies with the opinion formed at the Gastrointestinal Drugs AdCom (GIDAC) meeting held in September 2024. During the discussion, 13 panel members did not believe Intercept’s data adequately proved Ocaliva’s clinical benefit, whilst just one panellist voted in favour of the drug. In a second separate vote, 10 experts said the drug’s benefits did not outweigh its risks. One panellist voted that the therapy’s benefits did outweigh its risks while three panellists abstained. In its letter to Intercept, the FDA also said it was continuing to consider data from a post-marketing study called 747-302 (NCT02308111), in addition to other safety information. Ocaliva comes with a boxed warning of heightened risk of liver decompensation or failure if patients are dosed incorrectly. Intercept’s US president Vivek Devaraj said: “We believe in the totality of evidence supporting Ocaliva and intend to work closely with the FDA on next steps.” Ocaliva has suffered a rocky regulatory road in both the US and Europe. The FDA rejected Ocaliva’s use in nonalcoholic steatohepatitis (NASH) in June last year, a blow which forced Intercept to cut its workforce by a third. The company was then kept waiting on an FDA decision in PBC this year after the agency asked for more time to consider full approval, delaying the Prescription Drug User Fee Act (PDUFA) date that was originally set for 15 October. In the same month as the negative AdCom meeting, the European Commission (EC) withdrew Ocaliva’s conditional marketing authorisation as a second-line treatment for patients with PBC. The EC made its decision following the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, which reassessed the benefit-risk profile of the drug. In a surprise decision just days later, the President of the General Court of the European Union overruled the decision, allowing Ocaliva to remain on the market. PBC, which disproportionally affects women, is a type of liver disease characterised by inflamed bile ducts which are progressively destroyed due to the build-up of bile. Ocaliva targets the farnesoid X receptor (FXR) to reduce bile acid production and promote its removal. Ocaliva’s scrutiny comes at a time of a new arrival in the PBC space. The FDA granted accelerated approval to Gilead’s Livdelzi (seladelpar) in August this year, a drug Gilead acquired from CymaBay Therapeutics in a $4.3bn dea l. Livdelzi is forecast to generate $558m in 2030, according to GlobalData’s Pharma Intelligence Centre. GlobalData is the parent company of Pharmaceutical Technology . Intercept has been operating as a subsidiary of Italy-based Alfasigma following a $794m acquisition in September 2023. Before coming under the Alfasigma umbrella, Ocaliva earned $285.7m in 2022.

AcquisitionAccelerated ApprovalDrug Approval

100 Deals associated with Obeticholic acid

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KEGG	Wiki	ATC	Drug Bank
D09360	Obeticholic acid	A05AA04	DB05990

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Primary Biliary Cholangitis	AU	CHIESI AUSTRALIA PTY LTD	21 Sep 2018
Liver Cirrhosis, Biliary	US	Intercept Pharmaceuticals, Inc.	27 May 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 1	US	Intercept Pharmaceuticals, Inc.	20 Sep 2019
Nonalcoholic Steatohepatitis	Discovery	US	Intercept Pharmaceuticals, Inc.	20 Sep 2019
Primary Biliary Cholangitis	Discovery	NO	Advanz Pharma Corp. Ltd.	12 Dec 2016
Primary Biliary Cholangitis	Discovery	LI	Advanz Pharma Corp. Ltd.	12 Dec 2016
Primary Biliary Cholangitis	Discovery	IS	Advanz Pharma Corp. Ltd.	12 Dec 2016
Primary Biliary Cholangitis	Discovery	EU	Advanz Pharma Corp. Ltd.	12 Dec 2016
Primary Biliary Cholangitis	Discovery	IS	Advanz Pharma Corp. Ltd.	12 Dec 2016
Primary Biliary Cholangitis	Discovery	NO	Advanz Pharma Corp. Ltd.	12 Dec 2016
Primary Biliary Cholangitis	Discovery	EU	Advanz Pharma Corp. Ltd.	12 Dec 2016
Primary Biliary Cholangitis	Discovery	LI	Advanz Pharma Corp. Ltd.	12 Dec 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02308111 (COBALT, GlobeNewswire) Manual	Not Applicable	Primary Biliary Cholangitis	-	obeticholic acid	(quhmopcosq) = zapuuslkpl dmeuvqbmok (eqsygljbnk )	Positive	06 Sep 2024
				external control	(quhmopcosq) = eefzxedufj dmeuvqbmok (eqsygljbnk )
NCT02548351 (REGENERATE, CTgov)	Phase 3	Nonalcoholic Steatohepatitis \| Fibrosis	2,477	Placebo	mlzkhsnugt(srhjlquwez) = ebhnfzgrks kxovoyjpqb (znzsyeetmx, kmkvkeezds - ykshsaoorp) View more	-	05 Sep 2024
DDW2024	Not Applicable	Primary Biliary Cholangitis	-	Obeticholic acid (OCA)	(xiexfhdvdc) = zkfzpkmsxe egaxgijmda (pluvgodvrn ) View more	-	20 May 2024
				OBETICHOLIC ACIDOCAOLIC ACID (Non-OCA control group)	(xiexfhdvdc) = wkrhxfyybw egaxgijmda (pluvgodvrn ) View more
DDW2024	Not Applicable	Primary Biliary Cholangitis	-	Obeticholic acid (OCA)	(gujmbdemne) = abjjvljawc fhqksmqnud (cfbbqhpuuk ) View more	-	20 May 2024
				OBETICHOLIC ACIDOCAOLIC ACID (Non-OCA control group)	(gujmbdemne) = asfvjcitts fhqksmqnud (cfbbqhpuuk ) View more
DDW2024	Not Applicable	Primary Biliary Cholangitis	-	Obeticholic acid (OCA)	(kvhzvpxmkc) = utpzbdldsr aomhmzzuio (bjqgjbzjsq ) View more	-	20 May 2024
				OBETICHOLIC ACIDOCAOLIC ACID (Non-OCA control group)	(kvhzvpxmkc) = aqnvplohoh aomhmzzuio (bjqgjbzjsq ) View more
DDW2024	Not Applicable	Primary Biliary Cholangitis	-	Obeticholic acid (OCA)	(dduwdokyab) = dxxfqhnwbb hqkzpnnmed (zaprscygqo ) View more	-	20 May 2024
				OBETICHOLIC ACIDOCAOLIC ACID (Non-OCA control group)	(dduwdokyab) = mreddoiobg hqkzpnnmed (zaprscygqo ) View more
NCT04594694 (747-213, GlobeNewswire) Manual	Phase 2	Primary Biliary Cholangitis	75	bezafibrate 400 mg SR + OCA 5 mg titrated to 10 mg at week 4	(jxidzuzdox) = vbhzemtqhb ijctyfyusn (xazkmhxlcv ) View more	Positive	18 May 2024
				bezafibrate 200 mg IR + OCA 5 mg titrated to 10 mg at week 4	(jxidzuzdox) = dzdrdgdjnq ijctyfyusn (xazkmhxlcv ) View more
NCT02430077 (CTgov)	Phase 2	Lipodystrophy, Familial Partial	10	Obeticholic Acid	gmmbrsmhtq(myqfyqkhwr) = qvwxuucidf rjajxsrqwe (zrtpfzbzuu, zbrsowbqdl - jqhosjlrcb) View more	-	13 Dec 2023
REVERSE (AASLD2023)	Phase 3	Compensated cirrhosis	919	Placebo	ryprlfieln(xmzqpgqouu) = OCA resulted in reduced ALT levels vs placebo eioskgbdie (ispjkjvndf ) View more	-	10 Nov 2023
				OCA 10 mg
AASLD2023	Not Applicable	Primary Biliary Cholangitis	-	obeticholic acid	tnuylxxhpl(xkgyrffbdj): hazard ratio = 1.22 (95% CI, 1.196 - 1.245), P-Value = <0.001	-	10 Nov 2023
				obeticholic acid

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