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Research Report
ABI-6250: An Investigational Oral NTCP Inhibitor for Chronic Hepatitis D Virus Infection
I. Introduction to ABI-6250
A. Overview of ABI-6250
ABI-6250 is an investigational, orally bioavailable, small-molecule therapeutic candidate under development by Assembly Biosciences.[1] It is classified as a viral entry inhibitor, specifically designed to target the sodium taurocholate cotransporting polypeptide (NTCP), which serves as the primary receptor for Hepatitis D Virus (HDV) and Hepatitis B Virus (HBV) entry into hepatocytes.[3] The development program for ABI-6250 aims to provide a convenient once-daily oral treatment option for chronic HDV infection, a condition with significant unmet medical needs.[1] This oral administration route represents a strategic focus, aiming to improve upon the existing injectable therapies for this severe viral disease by offering enhanced patient convenience and potentially better long-term adherence to treatment.[3] The pursuit of an oral agent for a clinically validated target like NTCP signifies a deliberate effort to combine proven biological mechanisms with improved pharmaceutical properties.
B. Developer: Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the discovery, development, and commercialization of innovative small-molecule therapeutics for the treatment of serious viral diseases.[3] The company's pipeline focuses on addressing the chronic impacts of infections such as herpesvirus, HBV, and notably, HDV.[3] ABI-6250 was nominated as a key development candidate for chronic HDV infection in October 2023, underscoring the company's commitment to advancing novel antiviral therapies.[2]
C. Target Indication: Chronic Hepatitis D Virus (HDV) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/18 | Phase 1 | Recruiting |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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PPB Drug Approvals
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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
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
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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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