Overview
Efinopegdutide is under investigation in clinical trial NCT03606057 (A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Efinopegdutide (MK-6024): A Comprehensive Profile of an Investigational Dual GLP-1/Glucagon Receptor Agonist for Metabolic Liver Disease
I. Introduction to Efinopegdutide (MK-6024)
A. Overview
Efinopegdutide is an investigational biopharmaceutical agent currently undergoing clinical evaluation, primarily for the treatment of metabolic liver diseases such as nonalcoholic steatohepatitis (NASH), a condition increasingly referred to as metabolic dysfunction-associated steatohepatitis (MASH).[1] It represents a novel therapeutic approach based on its mechanism as a potent dual agonist targeting both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR).[4] This dual agonism is hypothesized to confer specific advantages in managing the complex pathophysiology of NASH/MASH, potentially offering greater efficacy in reducing liver fat and inflammation compared to therapies targeting only the GLP-1 pathway.[5]
The development trajectory of Efinopegdutide has involved multiple pharmaceutical entities, reflected in its various identifiers throughout its history. This suggests a complex path influenced by shifting strategic priorities and evolving assessments of the drug's therapeutic potential across different indications.[4] The consistent emphasis on its dual GLP-1/Glucagon mechanism, however, underscores this feature as the central scientific rationale driving its current development focus on liver disease.[4]
B. Identification
The compound is internationally recognized by the nonproprietary name Efinopegdutide. Key identifiers used during its development and within scientific databases include:
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/02/20 | Phase 1 | Completed | |||
2024/11/22 | Phase 1 | Completed | |||
2024/07/01 | Phase 2 | Completed | |||
2023/09/25 | Phase 1 | Completed | |||
2023/05/26 | Phase 2 | Active, not recruiting | |||
2021/06/30 | Phase 2 | Completed | |||
2018/08/07 | Phase 1 | Terminated | |||
2018/07/30 | Phase 1 | Completed | |||
2018/07/16 | Phase 1 | Completed | |||
2018/07/16 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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