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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: 31 Jul 2025

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At a glance

  • Originator Tolerance Therapeutics
  • Developer MacroGenics; Provention Bio; Sanofi
  • Class Antihyperglycaemics; 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

  • 28 Jul 2025 Sanofi plans the phase III βETA PRESERVE trial for Type 1 diabetes mellitus (In adolescents, In adults, In children, In infants, Newly diagnosed, Adjunctive treatment) (IV, Infusion) (NCT07088068)
  • 13 May 2025 Sanofi anticipates a decision from the EMA and NMPA China regarding MAA during the second half of 2025
  • 30 Apr 2025 Preregistration for Type 1 diabetes mellitus (In children, In adolescents) in China (IV), prior to April 2025

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