Ibalizumab

Generic Name: Ibalizumab

Brand Names: Trogarzo

Drug Type: Biotech

CAS Number: 680188-33-4

Unique Ingredient Identifier: LT369U66CE

Background: Ibalizumab (also known as ibalizumab-uiyk and formerly known as TNX-355) is a monoclonal antibody that binds to CD4 receptors on the surface of CD4-positive cells, preventing HIV particle entry into the lymphocytes. It is an advanced and current antibody in development for the treatment of HIV/AIDS. It has been developed by Taimed biologics and Theratechnologies .

This drug was approved in March 2018 for the management of treatment-resistant HIV . In October 2022, the FDA approved the administration of Trogarzo (ibalizumab-uiyk) by intravenous push, allowing for a faster drug administration.

Indication: Indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in highly treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen .

The approval of Trogarzo was supported by a clinical trial of 40 treatment-experienced adults with MDR HIV-1 infection who persistently had elevated levels of HIV RNA in their blood despite heavy antiretroviral therapy. The majority of study patients had previously been treated with ≥10 antiretroviral medications .

Associated Conditions: Multidrug resistant HIV-1 infection

Clinical Trials

External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA

Completed

Conditions: HIV-1-infection

Interventions: Drug: Ibalizumab

First Posted Date: 2022-08-10

Last Posted Date: 2023-09-07

Lead Sponsor: Epividian

Target Recruit Count: 141

Registration Number: NCT05495204

Locations: 🇺🇸
Epividian, Durham, North Carolina, United States

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab

Recruiting

Conditions: HIV Infections
Multi-Antiviral Resistance

Interventions: Biological: On ibalizumab treatment
Other: No ibalizumab or Pre-ibalizumab treatment

First Posted Date: 2022-05-24

Last Posted Date: 2025-05-21

Lead Sponsor: Theratechnologies

Target Recruit Count: 200

Registration Number: NCT05388474

Locations: 🇺🇸
Indiana University Health Inc., Bloomington, Indiana, United States
🇺🇸
Ruane Clinical Research, Los Angeles, California, United States
🇺🇸
Mills Clinical Research, Los Angeles, California, United States

and more 33 locations

Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection

Phase 3

Completed

Conditions: HIV-1-infection

Interventions: Drug: ibalizumab-uiyk

First Posted Date: 2019-04-12

Last Posted Date: 2023-09-21

Lead Sponsor: TaiMed Biologics Inc.

Target Recruit Count: 46

Registration Number: NCT03913195

Locations: 🇺🇸
Anthony Mills MD Inc., Los Angeles, California, United States
🇺🇸
Gary Richmond MD, PA, Fort Lauderdale, Florida, United States
🇺🇸
North Texas Infectious Disease Consultants, Dallas, Texas, United States

and more 1 locations

Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

Phase 3

Completed

Conditions: HIV

Interventions: Drug: ibalizumab
Drug: Optimized Background Regimen

First Posted Date: 2016-03-14

Last Posted Date: 2021-03-11

Lead Sponsor: TaiMed Biologics Inc.

Target Recruit Count: 79

Registration Number: NCT02707861

Locations: 🇺🇸
Palmtree Clinical Research, Inc., Palm Springs, California, United States
🇺🇸
Southern California Permanente Medical Group, Los Angeles, California, United States
🇺🇸
Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center, Los Angeles, California, United States

and more 29 locations

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Conditions: Human Immunodeficiency Virus (HIV)

First Posted Date: 2014-01-07

Last Posted Date: 2016-11-01

Lead Sponsor: University of Colorado, Denver

Registration Number: NCT02028819

Locations: 🇺🇸
Denver Health, Denver, Colorado, United States

Investigator-Sponsored Protocol - Continued Use of Ibalizumab

Phase 2

Completed

Conditions: HIV Infections

Interventions: Drug: ibalizumab 2000mg Q4Weeks
Drug: ibalizumab 800mg Q2Weeks

First Posted Date: 2010-01-26

Last Posted Date: 2018-07-12

Lead Sponsor: Kaiser Permanente

Target Recruit Count: 5

Registration Number: NCT01056393

Locations: 🇺🇸
Kaiser Permanente Southern California, Los Angeles, California, United States

Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1

Phase 2

Completed

Conditions: HIV

Interventions: Drug: Ibalizumab

First Posted Date: 2008-11-02

Last Posted Date: 2014-05-05

Lead Sponsor: TaiMed Biologics Inc.

Target Recruit Count: 113

Registration Number: NCT00784147

Locations: 🇺🇸
Nationsmed Clinical Research, Houston, Texas, United States
🇺🇸
Dr. Gordon E. Crofoot, MD, PA, Houston, Texas, United States
🇺🇸
University of Miami, Miller School of Medicine, Miami, Florida, United States

and more 27 locations

TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1

Phase 2

Conditions: HIV Infections

First Posted Date: 2004-08-12

Last Posted Date: 2005-06-24

Lead Sponsor: Tanox

Target Recruit Count: 80

Registration Number: NCT00089700

Locations: 🇺🇸
Comprehensive Research Institute, Tampa, Florida, United States
🇵🇷
Clinical Research Puerto Rico, Inc., San Juan, Puerto Rico
🇨🇦
Sunnybrook Health Science Centre, Toronto, Ontario, Canada

and more 12 locations

Drug Development Updates

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