Monoclonal antibody · Metabolic / Diabetes

Teplizumab

Tzield
BiologicCD3-directed T-cell modulator (monoclonal antibody)

UniProt P07766 · 3D model

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An that calms down the immune cells attacking the pancreas, buying time before type 1 diabetes fully develops.

How it works

Teplizumab is a lab-made antibody that attaches to a protein called CD3 on T cells — the immune cells that mistakenly attack the insulin-producing cells in the pancreas in type 1 diabetes. Rather than killing these T cells, it temporarily reprograms them: it dials down their attack signal, encourages more of the immune system's own regulatory cells, and pushes the aggressive T cells toward a worn-out, less active state, slowing the immune attack on the pancreas.

What it’s used for

Tzield is approved to push back the point at which early-stage (Stage 2) type 1 diabetes turns into full-blown (Stage 3) disease requiring insulin therapy, in people age 1 and up. It's also approved to slow the loss of the body's own insulin production in children and teens recently diagnosed with Stage 3 type 1 diabetes. In the trial behind its approval, a single two-week course of treatment delayed diagnosis by about two years on average compared to placebo.

Mechanism
CD3-directed T-cell ()
Drug class
Monoclonal antibody
Therapeutic area
Metabolic / Diabetes
MilestoneApproved November 17, 2022
First drug ever approved to delay the onset of type 1 diabetes, not just treat it

The first drug that delays a disease before it fully starts

Type 1 diabetes doesn't appear overnight — there's often a silent stage beforehand where the immune system is already attacking the pancreas, detectable by blood tests, before a person has any symptoms. Teplizumab was the first drug ever approved to intervene at that earlier stage: a two-week course of infusions calms down the immune attack enough to buy patients real time, an extra two years on average, before they need insulin. It doesn't cure or fully prevent the disease, but it was the first drug of any kind shown to delay a disease's onset in this way, not just treat it once it arrives.

Pivotal trial

TN-10 (NCT01030861) ↗

A TrialNet randomized, placebo-controlled trial in relatives of type 1 diabetes patients with stage 2 (pre-symptomatic, autoantibody-positive) disease, in which a single course of teplizumab delayed median time to clinical diagnosis by about two years versus placebo.

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