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Leronlimab - CytoDyn

Drug Profile

Leronlimab - CytoDyn

Alternative Names: PA-14; PRO-140; Vyrologix - CytoDyn

Latest Information Update: 16 Oct 2020

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At a glance

  • Originator Progenics Pharmaceuticals
  • Developer CytoDyn; Progenics Pharmaceuticals
  • Class Antineoplastics; Antiretrovirals; Antivirals; Hepatoprotectants; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CCR5 receptor antagonists; T lymphocyte stimulants; Virus internalisation inhibitors
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III COVID 2019 infections; HIV infections; HIV-1 infections
  • Phase II Breast cancer; Graft-versus-host disease; Non-alcoholic steatohepatitis; Solid tumours

Most Recent Events

  • 12 Oct 2020 CytoDyn announces intention to submit NDA to FDA (Phillipines) for COVID-2019 infections
  • 02 Sep 2020 Medicines & Healthcare product Regulatory Agency (MHRA) has requested a meeting with CytoDyn on 9 September 2020 for the discussion of fast track approval request for leronlimab to treat COVID-2019 infections.
  • 02 Sep 2020 US FDA has scheduled a type A meeting with CytoDyn on 8 September 2020 for BLA of leronlimab in the treatment of HIV patients.
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