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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: 20 Mar 2024

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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
  • Available For Licensing Yes

Highest Development Phases

  • Marketed HIV-1 infections
  • Preclinical HIV-2 infections

Most Recent Events

  • 18 Mar 2024 Ibalizumab Commercialized to AcedrA BioPharmaceuticals in the Middle East and North Africa Region
  • 27 Feb 2024 Theratechnologies receives a refusal to file letter from the FDA for ibalizumab (Trogarzo®) in HIV-1 infections
  • 02 Jan 2024 Preregistration for HIV-1 infections (Treatment-experienced) in USA (IM)
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