Biliary Cholangitis
📧 Sign up to get email alerts when something new happens for Biliary Cholangitis.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2024-12-04Clinical Trial Update: Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis [Phase 3]
A Phase 3 trial comparing obeticholic acid versus placebo in combination with ursodeoxycholic acid for primary biliary cirrhosis has complet…
-
CLINICAL_TRIALS trial_result · 2024-09-27Clinical Trial Update: Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis [Phase 2]
A Phase 2 clinical trial evaluating ASC42 tablets for safety and efficacy in primary biliary cholangitis has completed.
-
CLINICAL_TRIALS research · 2024-09-20Clinical Trial Update: PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.
An ongoing clinical trial update evaluating the 11C-Csar tracer, a bile acid analog, to image hepatobiliary changes in Primary Biliary Chola…
-
CLINICAL_TRIALS trial_result · 2024-09-19Clinical Trial Update: Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis [Phase 2]
This clinical trial update reports on the Phase 2 study evaluating safety, tolerability, and efficacy of saroglitazar magnesium in patients …
-
CLINICAL_TRIALS trial_result · 2024-09-05Clinical Trial Update: Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) [Phase 3]
Ipsen announced Phase 3 results for elafibranor in patients with primary biliary cholangitis; the study is listed as ACTIVE_NOT_RECRUITING w…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2024-08-09Clinical Trial Update: Early Identification of Myocardial Impairment in PBC
Clinical trial update on early identification of myocardial impairment in Primary Biliary Cholangitis; results have been posted.
-
CLINICAL_TRIALS trial_result · 2024-07-25Clinical Trial Update: RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) [Phase 3]
Phase 3 trial of seladelpar in primary biliary cholangitis has completed, and results have been posted.
-
CLINICAL_TRIALS trial_result · 2024-07-11Clinical Trial Update: Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis [Phase 3]
A Phase 3 clinical trial evaluating the efficacy and safety of obeticholic acid for primary biliary cholangitis has completed.
-
EMA withdrawal · 2024-06-28EMA recommends revoking conditional marketing authorisation for Ocaliva
EMA recommends revoking the conditional marketing authorisation for Ocaliva (obeticholic acid) after concluding that its benefits no longer …
-
FDA approval · 2024-06-17FDA Approved: URSODIOL — Supplemental Application (KVK-Tech, Inc.)
FDA approved a supplemental application for Ursodiol (ursodiol) filed by KVK-Tech, Inc. under ANDA210707. This action supports the continued…
-
CLINICAL_TRIALS trial_result · 2024-06-06Clinical Trial Update: Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia [Phase 1, Phase 2]
Phase 1/2 clinical trial evaluating umbilical cord–derived mesenchymal stem cell transplantation in children with biliary atresia; the study…
-
CLINICAL_TRIALS research · 2024-05-16Clinical Trial Update: Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases [EARLY_Phase 1]
A preliminary Phase 1 study is planned to evaluate UTAA09 injections for relapsed/refractory autoimmune diseases, with recruitment not yet s…
-
CLINICAL_TRIALS trial_result · 2024-04-24Clinical Trial Update: Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis [Phase 2]
An open-label Phase 2 study of HTD1801 in adults with primary biliary cholangitis has completed with results posted.
-
CLINICAL_TRIALS trial_result · 2024-04-17Clinical Trial Update: Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule [Phase 4]
Clinical trial update for a Phase 4 study evaluating Baobao Dan Capsule for elevated total bilirubin in Primary Biliary Cholangitis.
-
CLINICAL_TRIALS trial_result · 2024-02-16Clinical Trial Update: Combination Antiretroviral Therapy (cART) for PBC [Phase 2]
Phase 2 clinical trial update on combination antiretroviral therapy for Primary Biliary Cholangitis has completed.
-
FDA approval · 2023-12-06FDA Approved: URSODIOL — Supplemental Application (Laurus Labs Limited)
FDA approved Laurus Labs Limited's supplemental application for ursodiol (ursodeoxycholic acid) under an ANDA.
-
FDA approval · 2023-11-28FDA Approved: URSODIOL — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved a supplemental application for URSODIOL by Zydus Pharmaceuticals (USA) Inc.
-
FDA approval · 2023-10-26FDA Approved: URSODIOL — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for ursodiol (ursodeoxycholic acid) from Lannett Company, Inc., adding changes to the existing appro…
-
FDA approval · 2023-10-25FDA Approved: URSODIOL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for Ursodiol from Strides Pharma Science Limited, expanding or updating its labeling/indications…
-
FDA approval · 2023-10-25FDA Approved: URSODIOL — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for URSODIOL from Aurobindo Pharma Limited, resulting in approval of the generic ursodiol product un…
-
FDA approval · 2023-07-19FDA Approved: URSODIOL — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for URSODIOL from Actavis Pharma, Inc.
-
FDA approval · 2023-06-30FDA Approved: URSODIOL — Supplemental Application (Strides Pharma Science Limited)
The FDA approved a supplemental application for Ursodiol (ursodiol) from Strides Pharma Science Limited.
-
CLINICAL_TRIALS trial_result · 2023-03-09Clinical Trial Update: Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis [Phase 4]
Phase 4 trial of obeticholic acid in primary biliary cholangitis was terminated; results posted in 2023.
-
FDA approval · 2023-01-12FDA Approved: URSO 250 — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for URSO 250 (ursodiol) submitted by Allergan, Inc.
-
CLINICAL_TRIALS trial_result · 2022-09-06Clinical Trial Update: Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment [Phase 4]
A Phase 4 clinical trial studying the pharmacokinetics and safety of obeticholic acid in participants with primary biliary cholangitis and h…