Drug Profile


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

Latest Information Update: 06 Oct 2017

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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

  • Preregistration HIV-1 infections

Most Recent Events

  • 13 Nov 2017 FDA assigns PDUFA action date of 03/04/2018 for ibalizumab for HIV-1 infections (Treatment experienced) (IV)
  • 04 Oct 2017 Safety and efficacy data from the phase III TMB-311 trial in HIV-1 infections released by Theratechnologies
  • 30 Jun 2017 The US FDA accepts the BLA for ibalizumab for HIV-1 infections for priority review
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