Teplizumab: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Teplizumab appears in the FDA drug-label database. Marketed as TZIELD.

Drug class

CD3-directed Antibody (FDA established pharmacologic class)

Mechanism of action

CD3-directed Antibody Interactions (as stated on the FDA label)

Boxed warning

The FDA label for Teplizumab carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

TZIELD is indicated to [see Dosage and Administration (2.1) ]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: There is limited evidence of safety and effectiveness in patients aged 45 years and older with Stage 2 T1D. TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions . TZIELD is a CD3-directed antibody indicated to: ( 1 ) Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduc…

FDA label via openFDA