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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: 08 Mar 2026

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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

  • 26 Feb 2026 FDA assigns PDUFA action date of 29/04/2026 for teplizumab for Type-1 Diabetes mellitus (In infants, In children, In adolescents, In adults)
  • 26 Feb 2026 Sanofi expects a regulatory decision from the US FDA on the supplemental biologics license application (sBLA) for Type-1 Diabetes mellitus (In children, In adolescents, In adults, Prevention)
  • 28 Jan 2026 Preregistration for Type 1 diabetes mellitus (In adolescents, In children, In adults) in European Union (IV), before January 2025

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