Ibalizumab

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA	2022/08/10	NCT05495204	N/A	Completed	Epividian
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab	2022/05/24	NCT05388474	N/A	Recruiting	Theratechnologies
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection	2019/04/12	NCT03913195	Phase 3	Completed	TaiMed Biologics Inc.
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1	2016/03/14	NCT02707861	Phase 3	Completed	TaiMed Biologics Inc.
Compassionate Use of Ibalizumab for the Treatment of HIV Infection	2014/01/07	NCT02028819	N/A	NO_LONGER_AVAILABLE	University of Colorado, Denver
Investigator-Sponsored Protocol - Continued Use of Ibalizumab	2010/01/26	NCT01056393	Phase 2	Completed	Kaiser Permanente
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1	2008/11/02	NCT00784147	Phase 2	Completed	TaiMed Biologics Inc.
TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1	2004/08/12	NCT00089700	Phase 2	UNKNOWN	Tanox

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TROGARZO	Theratechnologies Inc.	62064-122	INTRAVENOUS	150 mg in 1 mL	4/19/2018

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
TROGARZO 200 mg CONCENTRADO PARA SOLUCION PARA PERFUSION	Theratechnologies Europe Limited	1191359001	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized

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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