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Research Report
Comprehensive Analysis of the Investigational siRNA Therapeutic NN-6581 for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Executive Summary
This report provides a comprehensive analysis of NN-6581, an investigational small interfering RNA (siRNA) therapeutic developed by Novo Nordisk for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and its precursor, hepatic steatosis. NN-6581 represents a novel, genetically-validated approach within a rapidly evolving and highly competitive therapeutic landscape. The drug's mechanism of action is predicated on RNA interference (RNAi) to specifically silence the expression of the mitochondrial amidoxime-reducing component 1 (MARC1) gene, a target with strong human genetic validation. Common loss-of-function variants in MARC1 are associated with protection against liver disease progression, and preclinical studies suggest that inhibiting MARC1 reduces hepatocyte lipid content by increasing fatty acid oxidation. This liver-directed mechanism distinguishes NN-6581 from the leading systemic metabolic modulators, such as GLP-1 receptor agonists, that currently dominate the late-stage MASH pipeline.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/24 | Phase 1 | Recruiting | |||
2022/10/31 | Phase 1 | Active, not recruiting |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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| No UK EMC drug information found for this drug. | |||||
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