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Research Report
Firzacorvir (ABI-H2158): A Comprehensive Monograph on a Potent HBV Core Inhibitor from Promising Clinical Candidate to Discontinuation
Section 1: Introduction and Synopsis
Executive Overview
Firzacorvir, known by its developmental designation ABI-H2158, is an investigational, orally bioavailable small molecule that was under development by Assembly Biosciences, Inc..[1] It was engineered as a second-generation therapeutic agent for the treatment of chronic hepatitis B (cHBV) infection. As a member of the cyclic sulfamide chemical class, Firzacorvir was designed to function as a potent, pan-genotypic Hepatitis B Virus (HBV) core protein inhibitor.[1] The HBV core protein is an essential, multifunctional viral protein with no human homologue, making it a highly attractive target for antiviral intervention.[4] Firzacorvir represented a significant advancement in the field, with preclinical data suggesting a powerful dual mechanism of action that held the potential to not only suppress viral replication but also to target the persistent viral reservoir, offering a tangible prospect for a functional cure for the millions affected by cHBV worldwide.[1]
The Narrative Arc
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/05/21 | Phase 2 | Terminated | |||
2019/10/29 | Phase 1 | Completed | |||
2018/10/22 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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