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Teplizumab - Provention Bio

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Drug Profile

Teplizumab - Provention Bio

Alternative Names: hOKT3-gamma-1-ala-ala; hOKT3-γ1-ala-ala; MGA-031; PRV 031; PVR031; Teplizumab-mzwv; TZIELD

Latest Information Update: 24 Nov 2025

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At a glance

  • Originator Tolerance Therapeutics
  • Developer MacroGenics; Provention Bio; Sanofi
  • Class Antihyperglycaemics; Antipsoriatics; Antirheumatics; Monoclonal antibodies
  • Mechanism of Action CD3 antigen inhibitors
  • Orphan Drug Status

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

    Yes - Type 1 diabetes mellitus
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Type 1 diabetes mellitus
  • Discontinued Multiple sclerosis; Psoriasis; Psoriatic arthritis

Most Recent Events

  • 14 Nov 2025 CHMP recommends approval of Teplizumab for Type 1 diabetes mellitus in European union
  • 14 Nov 2025 Adverse events and efficacy data from a phase II trial in Type 1 diabetes mellitus released by prevention Bio
  • 20 Oct 2025 The US FDA accepts for expedited review the supplemental biologics license application (sBLA) for Teplizumab in Type I diabetes

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