Noduca (norursodeoxycholic acid) / Shilpa Medicare - LARVOL DELTA

Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients. (PubMed, World J Hepatol) - "NorUDCA 1500 mg demonstrated clinically meaningful therapeutic efficacy in patients with MASLD, accompanied by consistently favorable safety profile."

Clinical • Journal • P3 data • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Modeling the reactive cholangiocyte phenotype in cholangiopathies using human biliary organoids for evaluation of novel therapeutic compounds (FFS-AIH 2025) - "This study aims to (i) characterize the molecular pathways underlying cholangiocyte reactivity using human organoid cultures, (ii) explore the therapeutic effects of the novel hydro-philic, therapeutic BAs norucholic acid (norUDCA/NCA) and tetrahydroxylated BAs (THBA) on activated cholangiocytes. mRNA-expression profiling demonstrated that the combination of IL-17A and TNFα exerted synergistic effects, elevating Ccl20 128-fold, significantly above single cytokine (7-fold IL-17a; 21.1-fold TNFα) treatments (p < 0.0001). Co-treatment with 0.1 μM THBA significantly attenuated the IL-17A/TNFα-mediated inflammatory response, reducing Ccl2 (by 23%, p = 0.013), Cxcl2 (60%, p = 0.015) IL-8 (53%, p = 0.039) and Ccl20 (40%, p = 0.027) expression. NCA also demonstrated anti-inflammatory effects, decreasing Ccl2 (22%, p = 0.015), and Cxcl2 (45%, p = 0.05)."

Cholestasis • Hepatology • Inflammation • CCL2 • CCL20 • CXCL10 • CXCL8 • IFNG • IL17A

Recent Advances in Primary Sclerosing Cholangitis Pathogenesis and Targets for Therapeutic Intervention (AASLD 2025) - "Treatment with nor-ursodeoxycholic acid (norUDCA) and nonsteroidal farnesoid X receptor agonist (cilofexor) are being tested in phase 3 clinical trials to assess improvement of liver function in patients with PSC. Review current treatments for PSC. Discuss novel experimental approaches for the treatment of PSC."

Fibrosis • Hepatology • Immunology • Liver Failure

Shilpa Medicare gets Shilpa Medicare approval for novel NAFLD drug NorUDCA (Business Standard) - "Shilpa Medicare has announced the receipt of approval of its, Nor Ursodeoxycholic Acid (NorUDCA) Tablets 500 mg, by the Central Drugs Standard Control Organization (CDSCO), marking a major milestone in innovative NAFLD therapy in India...This approval will allow Shilpa to become the first company in the World to launch this novel product in any part of the World for NAFLD."

Approval • Metabolic Dysfunction-Associated Steatotic Liver Disease

Intrahepatic Cholestasis of Pregnancy: Diagnosis, Management, and Future Directions-A Review of the Literature. (PubMed, Diagnostics (Basel)) - "Ursodeoxycholic acid (UDCA) remains the primary pharmacologic treatment of intrahepatic cholestasis of pregnancy; however, its effect on perinatal outcomes is debated. Investigational therapies-including Volixibat, FXR agonists, 4-phenylbutyrate, and NorUDCA-are under exploration...Future research should prioritize identifying predictive biomarkers, refining treatment algorithms, and assessing long-term outcomes for both mothers and offspring. Special attention should also be given to the investigation of novel therapeutic targets."

Journal • Review • Cholestasis • Dermatology • Hepatology • Pruritus

Safety, Tolerability, and Pharmacokinetics of NorUrsodeoxycholic Acid (Shilpa Medicare Limited, India) in Healthy Adults: Results From a Phase I Open-Label Dose-Escalation Study. (PubMed, Adv Pharmacol Pharm Sci) - "Based on the safety and pharmacokinetic data, the recommended dosage for further clinical trials is 1500 mg/day. Trial Registration: Clinical Trials Registry-India: CTRI/2022/11/047561."

Journal • Medicare • P1 data • PK/PD data • Reimbursement • US reimbursement • Hepatology

Current status of pharmacotherapy for primary sclerosing cholangitis. (PubMed, Front Med (Lausanne)) - "This review not only provides certain information for clinical research and treatment of PSC, but it is also the first time that stem cell therapy has been linked to PSC, which is expected to improve cholestasis and liver inflammation in patients with PSC. The article provides explanations and comparisons of different drugs, offering a basis for future researchers to choose medications."

Journal • Review • Cholestasis • Hepatology • Infectious Disease • Inflammation • Transplantation

Benefits and challenges to therapeutic targeting of bile acid circulation in cholestatic liver disease. (PubMed, Hepatology) - "In addition to altering membrane transporter function by targeting IBAT/ASBT and NTCP, there are an array of potentially additive therapeutic approaches which include receptor agonists acting via nuclear receptor (FXR, PPAR)-mediated transcriptional modification of BA synthesis and transport genes and BA analogs such as norucholic acid (previously known as norUDCA) that undergo cholehepatic shunting. This article reviews established and emerging molecular and clinical rationales for therapeutic targeting of BA circulation and signaling in liver diseases with a specific focus on cholestatic disorders."

Journal • Cholestasis • Hepatology • Metabolic Disorders

Treatment of grafts not meeting criteria for transplantation with nor-ursodeoxycholic acid during normothermic machine perfusion reduces apoptosis and biliary injury markers (EASL 2025) - "The present data suggests an anti-apoptotic effect as well as an improvement in bile compostition after treatment of extended criteria donor grafts with norUDCA during NMP. NorUDCA might be able to ameliorate the detrimental effects of bile toxicity on the ischemia-injured biliary tree. Therefore, therapeutic application of norUDCA prior to transplantation seems promising, especially for liver grafts at risk for biliary complications."

IO biomarker • Cardiovascular • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Transplantation • BCL2 • CASP3

Active transport via bile salt export pump (Bsep/Abcb11) is not required for cholehepatic shunting and choleretic actions of Norucholic acid (NCA/norUDCA) in mice (EASL 2025) - "Our data indicate that transport via Bsep/Abcb11 is not essential for choleretic effects of unconjugated NCA. In contrast, transport of taurine-conjugated NCA into bile requires Bsep/Abcb11."

Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • ABCB1 • ABCC3