FAQs about teplizumab

What is teplizumab?

Teplizumab is the world’s first immunotherapy drug for T1D, which has been approved by the National Institute for Health and Care Excellence (NICE) for England and Wales to delay the onset of symptomatic T1D.

Teplizumab has been shown to delay the development of T1D in people in the earliest stages of the condition by an average of three years, giving them time without the pressure of having to constantly monitor their glucose levels and take insulin.

How does teplizumab work?

Teplizumab works by binding to receptors on certain immune cells called T cells. It doesn’t kill the immune cell but changes their behaviour by slowing down their aggressive actions. Once teplizumab is attached to the T cells, it nudges them into becoming more tolerant and less likely to attack the insulin-producing beta cells. It basically signals the immune system to stand down rather than to fight.

By initiating this response, the remaining beta cells are protected for longer and the body can continue to make insulin. This can, therefore, delay the onset of symptomatic T1D.

How is teplizumab administered?

Teplizumab is administered through a 14-day infusion which is given in a hospital. The infusions happen once a day for 14 days in a row, and each infusion takes 30-60 minutes. Once this is finished, you can go home until the next infusion appointment.

The dose is slowly increased over the first few days, allowing your body to adjust and reducing the chance of side effects. During the hospital visits, the staff will check your vital signs (such as blood pressure and temperature), ask about any symptoms after the treatment has started, and do some blood tests before and during the treatment.

What age is teplizumab licensed for?

Teplizumab has been licenced for anyone over the age of eight identified as being in stage 2 of T1D.

What is so exciting about teplizumab?

Teplizumab is the world’s first disease-modifying therapy available to delay symptomatic T1D. The approval of teplizumab proves that it is possible to develop drugs for T1D which can change lives for the better. This should lead to an increase in research for other disease-modifying therapies and bring about more treatments.

Why is delaying the progress of T1D so important?

A delay in symptomatic T1D of at least three years is has the potential to be transformational for people, in both the short and long term. Any period that a person does not have to be dependent on insulin means they are avoiding important risks such as hypoglycaemia and the significant constant burdens of life with T1D. This can also play a key role in preventing complications such as eye, kidney and heart diseases.

Another huge benefit of delaying symptomatic T1D is giving back time. This time could allow children to get through tough exam periods without worrying about having a hypo or prevent someone needing to take insulin during pregnancy. This time is precious and is something that is invaluable to the people who have already had teplizumab, such as Imogen.

Now NICE has approved teplizumab, what happens next?

Now that NICE has approved teplizumab, this treatment will be available in England and Wales on the NHS to people who fit the eligibility requirements. Training programmes will also be provided to teach clinicians how to manage people who have stage 2 T1D. Teplizumab must be fully funded by the NHS within 90 days of the final publication of the NICE guidance. In Wales, Teplizumab must be fully funded within 60 days of final publication of NICE guidance.

If you have been screened and meet the eligibility criteria, please speak to your healthcare practitioner about accessing this treatment.

What happens if I live in Scotland or Northern Ireland?

NICE technology appraisal guidance does not automatically apply in Northern Ireland; it is reviewed by the Department of Health for local applicability before being endorsed for implementation across Health and Social Care.

Scotland has a separate process.

Breakthrough T1D will continue to support conversations in Scotland and Northern Ireland to ensure teplizumab and other T1D treatments reach the people who need them.

How can I find out if I’m developing T1D?

There are trial screening programmes in the UK that test children’s blood for markers of the very early stages of T1D. One of these is called the ELSA study and screens children aged 2-17 years across the UK. There is also an adult-screening programme called T1DRA, which is open to people aged 18-70.

Every person between the age brackets for ELSA and T1DRA is eligible to be screened across all four nations in the UK

You can also ask your GP for a blood test to screen for the earliest stages of T1D. This is not a routine test, so you may be referred to a hospital for the testing to be done.

What research has been done on teplizumab?

Researchers have tested teplizumab in people recently diagnosed with stage 2 T1D in the TN-10 study. The results showed that teplizumab was safe and effective when used in clinical practice to treat stage 2 T1D. This study was proudly funded by Breakthrough T1D, alongside the National Institute of Health.

Researchers have also tested teplizumab in people recently diagnosed with T1D via the PROTECT study. The study was possible thanks to the Breakthrough T1D UK co-funded UK T1D Research Consortium, which recruits people with type 1 into UK clinical trials of new immunotherapy treatments

Research such as this is vital to develop disease modifying treatments. The more we know about protecting beta cells, the better.

How can I get involved with clinical trials for drugs like this in the future?

Involvement in clinical trials is key to progressing treatments such as teplizumab. Without involvement of people with T1D, it would never have been approved.

You can use our clinical trials finder to see which studies you may be eligible for.

Are other similar treatments being developed?

Other drugs that target the immune system – known as immunotherapy drugs – are being developed and tested on people with T1D. An example of this is the immunosuppressant anti thymocyte globulin (ATG). Results published in 2025 showed that ATG was successful at delaying T1D at lower doses in young people aged 5-25. The lower the dose, the less likely side effects are, which was an important safety benefit in this trial.

Another example of this is ustekinumab, a drug licensed to treat other autoimmune conditions including psoriasis, which is being trialled in children recently diagnosed with T1D. The approval of teplizumab sets a precedent that immunotherapies are a viable treatment for T1D. This encourages pharmaceutical companies to invest in them and paves the way for more drugs to become available.

How did Breakthrough T1D UK support the development of this drug?

As part of our mission to accelerate life-changing breakthroughs, Breakthrough T1D UK played a key role in funding early-stage research and facilitating regulatory pathways to help bring teplizumab to market.