Ibalizumab

Drug Profile

Ibalizumab

Alternative Names: 5AB; Hu5A8; Monoclonal antibody 5A8; TMB-355; TNX-355

Latest Information Update: 21 Feb 2017

Price : $50

At a glance

  • Originator Biogen Idec
  • Developer TaiMed Biologics
  • Class Antivirals; Monoclonal antibodies
  • Mechanism of Action CD4 antigen inhibitors; HIV fusion inhibitors; Virus internalisation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - HIV-1 infections
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III HIV-1 infections

Most Recent Events

  • 23 Feb 2017 TaiMed Biologics announces intention to submit BLA to the US FDA in March 2017
  • 15 Feb 2017 TaiMed Biologics initiates enrolment in a phase I/II trial for HIV-1 infections in Taiwan before February 2017
  • 14 Feb 2017 Efficay and adverse events data from phase III TMB-301 trial in HIV-1 infections (Treatment-experienced) released by Theratechnologies
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