Teplizumab - Provention Bio
Alternative Names: hOKT3-gamma-1-ala-ala; hOKT3-γ1-ala-ala; MGA-031; PRV 031; PVR031; Teplizumab-mzwv; TZIELDLatest Information Update: 23 May 2025
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.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Type 1 diabetes mellitus
- Discontinued Multiple sclerosis; Psoriasis; Psoriatic arthritis
Most Recent Events
- 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
- 30 Jan 2025 EMA accepts MAA for Teplizumab for Type 1 diabetes mellitus (In adolescents, In children) for review