Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
Trogarzo® IV Infusion  Discovery
 
Pre-clinical Studies
 
Phase I Studies
 
Phase II Studies
 
Phase III Studies
 
BLA / MAA
 
Market
 

TROGARZO® (ibalizumab-uiyk) Injection

TROGARZO® (ibalizumab-uiyk) stands as a groundbreaking achievement in the field of HIV therapy. It is the world’s first approved monoclonal antibody for HIV treatment with a long-acting effect. By directing its action towards CD4, it acts as a post-attachment HIV-1 inhibitor, preventing the entry of viruses into CD4+ cells. In both the United States and Europe, Trogarzo® proudly holds the distinction of being the first and currently the only approved monoclonal antibody for HIV therapy. When used in combination with other antiretroviral agent(s), it is indicated for heavily treatment-experienced adults with multidrug-resistant (MDR) HIV-1 infection who fail their current antiretroviral regimen. Trogarzo® is approved for intravenous administration through IV infusion and IV push in undiluted form every two weeks.

Trogarzo®Intravenous Push clinical results

TaiMed continues to work towards providing additional options for patients and healthcare professionals following the launch of TROGARZO® intravenous (i.v.) infusion. A Phase 3 clinical trial investigating the i.v. push route of administration was initiated in 2019. After completion of the trial, a label extension application has been submitted to U.S. FDA to include i.v. push as an additional route of administration.

The same formulation is used for both TROGARZO® i.v. infusion and i.v. push. The i.v. push route of administration will inject undiluted TROGARZO® via intravenous and provide a fast and convenient dosing option.

 
Milestones
  • 2019-10-01
    2019
    Initiation of a phase-3 clinical trial for i.v. push in the U.S.
  • 2019-10-01
    2021
    Completion of a phase-3 clinical study for i.v. push and an application for label extension.
  • 2019-10-01
    2022
    U.S. label approval.