Biliary Cholangitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2022-07-14Clinical Trial Update: Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) [Phase 2]
Phase 2 clinical trial update for seladelpar (MBX-8025) in subjects with primary biliary cholangitis has completed with results posted.
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CLINICAL_TRIALS trial_result · 2022-05-31Clinical Trial Update: ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) [Phase 3]
Phase 3 trial ENHANCE evaluating seladelpar in patients with primary biliary cholangitis who had inadequate response to or intolerance of UD…
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CLINICAL_TRIALS trial_result · 2022-05-10Clinical Trial Update: Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy [Phase 3]
Phase 3 clinical trial evaluating 24 months of bezafibrate for primary sclerosing cholangitis with persistent cholestasis despite ursodeoxyc…
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CLINICAL_TRIALS trial_result · 2022-03-24Clinical Trial Update: Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis [Phase 2]
Phase 2 trial of etrasimod (APD334) for primary biliary cholangitis was terminated; results posted in 2022.
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FDA approval · 2021-11-29FDA Approved: URSODIOL — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for Ursodiol (URSODIOL) submitted by BluePoint Laboratories.
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CLINICAL_TRIALS trial_result · 2021-06-22Clinical Trial Update: Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy [Phase 4]
Phase 4 trial comparing mycophenolate mofetil to cyclosporin A for treatment of autoimmune hepatitis-primary biliary cholangitis overlap syn…
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CLINICAL_TRIALS trial_result · 2021-05-18Clinical Trial Update: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis [Phase 2]
Phase 2 study evaluating safety, tolerability, pharmacokinetics, and efficacy of EDP-305 in subjects with primary biliary cholangitis has co…
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CLINICAL_TRIALS trial_result · 2021-05-04Clinical Trial Update: Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis [Phase 2]
Phase 2 dose-response study for GSK2330672 in pruritus associated with primary biliary cholangitis has completed with results posted.
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CLINICAL_TRIALS trial_result · 2021-03-24Clinical Trial Update: Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1 [Phase 4]
Phase 4 trial update evaluating ursodeoxycholic acid combined with total glucosides of paeony for primary biliary cholangitis with autoimmun…
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CLINICAL_TRIALS trial_result · 2021-03-22Clinical Trial Update: Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II [Phase 4]
Phase 4 trial update evaluating ursodeoxycholic acid with low-dose glucocorticoid for primary biliary cholangitis with autoimmune features.
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FDA approval · 2021-01-22FDA Approved: URSODIOL — Original Application (Strides Pharma Science Limited)
FDA approval of an original ANDA for Ursodiol (ursodeoxycholic acid) for Strides Pharma Science Limited, enabling its generic production. It…
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CLINICAL_TRIALS trial_result · 2020-10-14Clinical Trial Update: A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA [Phase 2]
Phase 2 clinical trial of baricitinib in participants with primary biliary cholangitis who do not respond or cannot take UDCA has been termi…
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FDA approval · 2020-08-20FDA Approved: URSODIOL — Original Application (Strides Pharma Science Limited)
The FDA approved URSODIOL as an original generic application from Strides Pharma Science Limited, enabling a generic ursodiol product to be …
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FDA approval · 2020-08-17FDA Approved: URSODIOL — Original Application (Chartwell RX, LLC)
FDA approved URSODIOL (ursodiol) from Chartwell RX, LLC under an Original Application (ANDA).
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FDA approval · 2020-02-12FDA Approved: URSODIOL — Original Application (Laurus Labs Limited)
FDA approves Laurus Labs Limited's URSODIOL under an Original Application (ANDA) for a generic ursodiol product.
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CLINICAL_TRIALS trial_result · 2020-01-13Clinical Trial Update: Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis [Phase 2]
Phase 2 study evaluating cilofexor in adults with primary biliary cholangitis without cirrhosis; study terminated with posted results in 202…
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CLINICAL_TRIALS trial_result · 2020-01-07Clinical Trial Update: Probiotics in PBC Patients of Poor Response to UDCA [Phase 2]
Phase 2 clinical trial evaluating probiotics in patients with primary biliary cholangitis who respond poorly to UDCA.
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CLINICAL_TRIALS trial_result · 2019-11-13Clinical Trial Update: A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients [Phase 2]
Phase 2 trial evaluating safety, tolerability, and efficacy of Tropifexor (LJN452) in patients with Primary Biliary Cholangitis has complete…
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CLINICAL_TRIALS trial_result · 2019-09-24Clinical Trial Update: Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid [Phase 2]
A Phase 2 clinical trial evaluating elafibranor for primary biliary cholangitis in patients with inadequate response to ursodeoxycholic acid…
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FDA approval · 2018-10-16FDA Approved: URSODIOL — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal's Ursodiol generic under an Original Application (ANDA 211301), enabling its marketing as a generic therapy.
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FDA approval · 2018-05-17FDA Approved: URSODIOL — Original Application (KVK-Tech, Inc.)
FDA approves the original application for Ursodiol (ursodiol) from KVK-Tech, Inc., confirming the generic's market authorization.
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CLINICAL_TRIALS trial_result · 2018-05-03Clinical Trial Update: A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis [Phase 4]
Phase 4 clinical trial evaluating high-dose ursodeoxycholic acid (18-22 mg/kg/day) in patients with refractory primary biliary cholangitis; …
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CLINICAL_TRIALS trial_result · 2018-04-26Clinical Trial Update: Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
A clinical trial update indicates the study of nalfurafine hydrochloride for pruritus in primary biliary cholangitis has completed.
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CLINICAL_TRIALS trial_result · 2018-04-23Clinical Trial Update: Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders [Phase 3]
This Phase 3 trial update summarizes the study evaluating bezafibrate to achieve complete biochemical response in non-responders with primar…
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CLINICAL_TRIALS trial_result · 2017-08-01Clinical Trial Update: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus [Phase 2]
A Phase 2 study assessed safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of GSK2330672 in adults with primary …