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Tzield (teplizumab) is the first disease-modifying therapy approved to treat type 1 diabetes (T1D) since insulin. It works by slowing the immune attack on insulin-making cells, potentially delaying progression from stage 2 to stage 3 T1D by an average of 2 years.

Now approved in Australia for people aged 8+ with stage 2 T1D, Tzield is administered as a 14–day infusion course.

This page answers key questions about how Tzield works, who’s eligible, access pathways through the PBS, and how it fits into the T1D treatment landscape – including emerging disease–modifying therapies and our research into cures.

FAQs about Tzield

Read our announcement about the TGA approval of Tzield in Australia.

You can also discover the history of Tzield and how Breakthrough T1D’s support made it happen.

Tzield is the brand name of the drug teplizumab, which is manufactured by Sanofi. It is a disease-modifying therapy, which means it targets the underlying process that causes T1D, the immune attack on the insulin-making beta cells in the pancreas. It helps slow the immune attack and protect beta cells by attaching to markers on immune cells called T-cells. Clinical trials have shown that Tzield can delay the progression to stage 3 T1D, when insulin is required, by an average of 2 years, buying people precious time without the daily burden of managing T1D.

The Therapeutic Goods Administration (TGA), which is the Government authority that regulates new drugs in Australia, has approved Tzield for people aged 8+ who have stage 2 T1D. This means people who have biological signs that the immune attack on their insulin-making cells has begun, and are beginning to have unstable blood glucose levels, but don’t yet have symptoms of T1D. In time, people with stage 2 T1D will progress to stage 3 T1D, when insulin is required, but Tzield can delay this process.

Tzield is given via an infusion, which means a small tube is placed into the inner elbow and the drug is given slowly through the tube over less than an hour. People receive a dose of Tzield in this way each day for 14 days, then do not need further treatment at this point. After this, people who have received Tzield are followed up in to monitor their progression to stage 3 T1D.

Any amount of time without the daily mental and physical burden of managing T1D with insulin therapy has a huge impact on quality of life. Time spent without experiencing hyperglycaemia (high blood glucose levels) helps reduce the risk of complications of T1D such as damage to the eyes, kidneys, and blood vessels.

People who have been treated with teplizumab are at lower risk of being diagnosed with stage 3 T1D in diabetic ketoacidosis (DKA), where blood glucose levels are dangerously high, causing acid to build up in the blood. DKA is an emergency situation, which can be fatal in the short-term and have a lasting negative impact on long-term health.

In children, delaying T1D also gives time for the pancreas to grow and develop, meaning that it is more resilient against the immune attack on the insulin-making beta cells.

Now Tzield has been approved by the TGA, it can be legally sold in Australia. To become accessible to the people who need it, it needs to be listed on the Pharmaceutical Benefits Scheme (PBS), which means it is subsidised by the Australian Government. The Pharmaceutical Benefits Advisory Committee (PBAC) will consider if Tzield should be included in the PBS at a meeting in July, and make a recommendation to the Government. If Tzield is listed on the PBS, people across the country who are eligible for it can access it at a subsidised cost. Breakthrough T1D will do everything we can to support a successful outcome.

While this regulatory process is happening, we are preparing the healthcare system to be able to administer Tzield and educating healthcare professionals on how to treat and support people who have stage 2 T1D through bespoke webinars and certified e-learning modules. We are also making sure we can identify people in stage 2 T1D who are eligible to received Tzield by supporting screening and monitoring initiatives in Australia.

Because people in stage 2 T1D don’t show any symptoms of the underlying T1D process, the only way to find out if you have it is through screening programs. People aged 2+ years who have a family member living with T1D can be screened for T1D through Type1Screen. This involves a simple finger prick blood test, which can be done at home and sent back to the lab to analyse.

A group of children aged 4-12 years at primary schools in New South Wales and South Australia are also being screened through the Australian T1D National Screening Pilot. We’re funding initiatives to build the evidence and infrastructure needed to enable population screening for T1D in Australia.

Researchers have also tested teplizumab in people recently diagnosed with T1D via the PROTECT study and continue to explore how the drug can benefit people already diagnosed with stage 3 T1D. We’re also helping to fund research into the potential for other disease-modifying therapies to be used in people with stage 3 T1D – see answer for ‘Are there any other treatments being developed for delaying T1D?’ for more detail on these.

At the same time, we’re focusing on cures for people with established T1D as well as initiatives to improve lives. Our extensive cures research portfolio includes cell therapies to replace the lost insulin-making cells to help people who have had T1D for some time create their own insulin once more. While our multi-faceted improving lives research portfolio includes adjunct therapies to help reduce or avoid T1D complications, investing in treatments and technologies to make blood glucose management easier, and initiatives to support behavioural health.

Like all medicines, Tzield can cause side effects, but these are generally mild. Reported side effects include headaches, flu-like symptoms, and rashes. Some people had a temporary lower level of white blood cells (immune cells that help fight off infections) than they should have but this soon returned to normal, with no lasting impact on immunity. People receiving Tzield are monitored closely by specialist healthcare professionals during and after receiving the medication to make sure they can be treated quickly if they are experiencing any side effects.

The clinical trials that tested Tzield and were used in the application to the TGA for its approval only included people aged 8 years and older, so at the time of submission, there wasn’t enough evidence that it is safe and effective for younger children to take. But Breakthrough T1D is funding more clinical trials testing Tzield, including the PETITE study where participants are aged 0-7 years withs stage 2 T1D. Early results show that Tzield is safe and not harmful to children under 8 with stage 2 T1D, prompting the US FDA expanding the population Tzield is approved for to ages 1+ years.

Globally, we are funding the development and testing of 6 other disease-modifying therapies that could delay – and one day maybe even prevent – the progression of T1D. For example, baricitinib, which Australian researchers first showed can delay the progression of T1D in people newly diagnosed with stage 3. Larger clinical trials of baricitinib are now taking place with trial sites around the world. Several other disease-modifying therapies for T1D are being tested in Australia – find out if you’re eligible to take part in any.

Some of these are drugs already approved to treat other autoimmune conditions are now being explored for use in T1D. For example, anti-thymocyte globulin (ATG), which is currently used to help prevent organ transplants being rejected by the recipient’s body. The approval of Tzield in Australia sets a precedent that disease-modifying therapies are an important treatment for T1D. This encourages pharmaceutical companies to invest in T1D therapies and paves the way for more drugs to become available in the future.

For almost 4 decades, Breakthrough T1D has played a vital role in supporting the development, testing and delivery of Tzield from funding exploratory research and clinical trials to facilitating regulatory pathways to secure access.

We have continuously funded a US-based researcher called Professor Kevan Herold since the late 1980s, who lives with T1D himself. He initially showed that an early version of teplizumab could prevent T1D in mice and developed this drug into a version that could be used in humans and ran clinical trials testing it. He continues to receive funding from Breakthrough T1D to better understand how teplizumab interferes with T1D development so that we can further delay its onset. We’re now supporting clinical trials exploring whether Tzield can treat people at other ages and stages of T1D.

We also fund infrastructure in Australia to enable clinical trials of drugs like Tzield to be tested here, such as the Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC). We are now working to support the regulatory process for Tzield so that people in Australia can access this groundbreaking drug.