ArticleAdvances in pharmacological and pharmaceutical sciences2025
Safety, Tolerability, and Pharmacokinetics of NorUrsodeoxycholic Acid (Shilpa Medicare Limited, India) in Healthy Adults: Results From a Phase I Open-Label Dose-Escalation Study.
Article in Advances in pharmacological and pharmaceutical sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients.World journal of hepatology · 2025Trial
- The conjugation-resistant bile acid norUDCA cures liver fibrosis but impairs systemic energy metabolism.Molecular metabolism · 2026Article
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Authors and funding
6 authors.
Funding
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Abstract
NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological properties, including cholehepatic shunting, making it a promising candidate for a range of cholestatic and metabolic liver diseases. This phase I study evaluates the safety, tolerability, and pharmacokinetics of single ascending doses of norUDCA in healthy adults under fasting conditions. In this open-label, dose-escalation study, healthy adults (aged 18-45 years) were enrolled into 3 successive dose escalation cohorts, receiving norUDCA oral tablets of 500 mg (
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