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Research Report
An Investigative Report on the Therapeutic Candidate FAB 117-HC
1. Introduction to FAB 117-HC
1.1. Overview and Initial Identification
FAB 117-HC is an investigational drug candidate that has emerged in recent research literature. However, a comprehensive review of available information reveals a complex and, at times, contradictory profile for this designation. The primary challenge in characterizing FAB 117-HC lies in its association with two distinct therapeutic modalities targeting different medical conditions.
A significant body of evidence points to FAB 117-HC as an advanced cell-based therapy primarily under investigation for the treatment of acute traumatic spinal cord injury.[1] This profile is supported by details regarding its active pharmaceutical ingredient, HC016, its originators, Ferrer Advanced Biotherapeutics and Histocell, and specific clinical trial identifiers (EudraCT 2015-005717-80 and NCT02917291).
Conversely, other sources describe FAB 117-HC, also identified by the alternative name NeuroSave, as a recombinant chimeric monoclonal antibody engineered for the treatment of acute ischemic stroke.[5] This profile outlines a mechanism involving the neutralization of human tissue factor.
The existence of these two fundamentally different therapeutic entities under the same primary designation, "FAB 117-HC," and sharing the alias "NeuroSave" [2], presents a critical discrepancy. This report will systematically delineate both profiles based on the available data, analyze these contradictions, and discuss potential interpretations, particularly concerning the "HC" suffix. The preponderance of detailed information relates to the cell therapy candidate for spinal cord injury, which will consequently receive more extensive coverage.
1.2. Significance of the "HC" Designation – Preliminary Assessment
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2016/09/28 | Phase 1 | UNKNOWN |
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
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
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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