MedPath

FAB 117-HC

Generic Name
FAB 117-HC

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: May 12, 2025

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

Continue reading the full research report

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.