EMERGING THERAPIES IN PRIMARY BILIARY CHOLANGITIS: OVERVIEW OF CLINICALTRIALS.GOV

Alorfi, Nasser M; Alourfi, Mansour; Alsharif, Saeed; Aljehani, Mohannad Abdulrahman; Alsabban, Abdulmalik Mohammed; Almatrafi, Mohammad J; Zakri, Ysear Abdulaziz; AlMahmoud, Abdullah; Ghunaiem, Monther F; Almalki, Rami Ahmad; Aljerary, Ibrahim Smran; Alkhattabi, Abdullah

doi:10.21608/bfsa.2023.247640.1961

EMERGING THERAPIES IN PRIMARY BILIARY CHOLANGITIS: OVERVIEW OF CLINICALTRIALS.GOV

Document Type : Review Article

Authors

¹ Pharmacology and Toxicology Department, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia

² Internal Medicine Department, King Faisal Medical City for Southern Region, Abha, Saudi Arabia

³ Department of Gastroenterology, East Jeddah Hospital, Jeddah, Saudi Arabia

⁴ Gastroenterology Department, Armed force Hospital of Southern Region, Khamis Mushait, Saudi Arabia

⁵ Division of Gastroenterology, Department of Medicine, King Faisal Specialist Hospital and Research Centre, Jeddah, Saudi Arabia

⁶ Gastroenterology Section, Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia

⁷ Gastroenterology Section, Internal Medicine Department, King Fahad Hospital, Jeddah, Saudi Arabia

⁸ Gastroenterology Section, Department of Internal Medicine, Collage of Medicine, Taibah University, Almadinah Almuawwarah, Saudi Arabia

⁹ Pharmaceutical care department, King Faisal Hospital, Makkah Cluster, Makkah, Saudi Arabia

10.21608/bfsa.2023.247640.1961

Abstract

Abstract

Background: Primary biliary cholangitis (PBC) is an autoimmune disorder leading to different hepatic disorders. Progressive bile duct damage could result in cirrhosis. However, different clinical trials are undergone to test, evaluate and analyze t therapeutics used for management of PBC.

Aim: Identifying the emerging therapies in primary biliary cholangitis.

Methods: A comprehensive analysis of clinicaltrials.gov registry on and up to 7th November 2023. A list of included trials based on the review’s inclusion and exclusion criteria was further investigated.

Results: 156 clinical trials linked to primary biliary cholangitis were found. Twenty of them are completed with result. Almost twenty chemical formula and medications were tested. These medications targeted fibrotic pathways, immune modulation, Selective farnesoid X receptor (FXR) agonist, ileal bile acid transport inhibitor and bile acid metabolism.

Conclusion: Several promising medications were found for primary biliary cholangitis. These medications undergo different stages of trials to evaluate their tolerability, efficacy, and safety. Further investigations are extremely warranted.

Keywords