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Ibalizumab - TaiMed Biologics

Drug Profile

Ibalizumab - TaiMed Biologics

Alternative Names: Hu1A8; Hu5A8; Ibalizumab-uiyk; TMB-355; TNX-355; Trogarzo

Latest Information Update: 21 Nov 2019

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At a glance

  • Originator Biogen Idec
  • Developer TaiMed Biologics; Theratechnologies
  • Class Antiretrovirals; Monoclonal antibodies
  • Mechanism of Action 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

  • Marketed HIV-1 infections

Most Recent Events

  • 07 Nov 2019 Updated efficacy data from the phase III TMB-311 trial in HIV-infections released by Theratechnologies
  • 03 Oct 2019 Updated efficacy and adverse events data from phase III TMB-311 trials in HIV-infections released by Theratechnologies
  • 26 Sep 2019 Registered for HIV-1 infections in European Union, Iceland, Liechtenstein, Norway (IV)
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