Tzield has become the first drug approved in Australia to delay the progression of type 1 diabetes (T1D), marking a new era in T1D treatment in this country.
The Therapeutic Goods Administration (TGA) has approved Tzield (teplizumab) to delay the onset of stage 3 T1D in people 8 years of age and older with stage 2 T1D.
In stage 2 T1D, biological signs of T1D are present in the blood and blood glucose levels have begun to change but there are no symptoms of T1D yet.
People with stage 2 T1D will gradually progress to stage 3 T1D, when people begin to experience the symptoms of T1D and insulin treatment is required. This process can take place over months or years. Tzield is proven to slow this progression by an average of 2 years, buying people precious time without the daily burden of managing T1D.
This is the first new therapy approved for T1D in over 100 years, since the discovery of insulin.
Unlike insulin, which is used to manage blood glucose levels after diagnosis, Tzield targets the disease process to delay progression to stage 3 T1D.
Approval by the TGA is the first step to making therapies available in Australia, but listing on the Pharmaceutical Benefits Scheme (PBS) is needed to make Tzield more accessible. Find more information on this below.
Dr Dorota Pawlak, Chief Scientific Officer at Breakthrough T1D, said:
Tzield is the first new therapy approved for T1D in over 100 years. Its approval in Australia signals an incredibly exciting turning point for Australians affected by the condition. Early treatment of T1D has lifelong health benefits and, alongside the very real potential for widespread T1D screening in the near future, can transform treatment for all Australians with the condition.
“Despite significant improvements in management, T1D is a relentless, 24/7 condition, and every day lived without it matters. Breakthrough T1D is proud to have supported decades of research to develop and test Tzield as well as major advocacy efforts to raise awareness of its importance. This is so important for our community, and we welcome Tzield’s listing with open arms.”
In this article:
About Tzield
Tzield is the brand name of the drug teplizumab, which is manufactured by Sanofi. It is a disease-modifying therapy (DMT), meaning it targets the underlying biological process that causes T1D, which is the immune attack on the insulin-making beta cells in the pancreas. The therapy helps slow this immune attack and protect beta cells by attaching to immune cells called T-cells and reducing the damage they cause.
Tzield is given via an infusion, which means the drug enters the body through a tube in the inner arm. Patients receive one teplizumab infusion (which can take up to 45 minutes) each day for 14 consecutive days. No further treatment is needed at this stage, but people are followed up after receiving teplizumab to monitor how their T1D is progressing.
Tzield is already approved to delay stage 3 T1D in the United States, the United Kingdom, the European Union (under the name Teizeild), China, Canada, Israel, the Kingdom of Saudi Arabia, the United Arab Emirates, and Kuwait.
Why Tzield is important
Treating people in stage 2 T1D with Tzield gives them precious time without the daily mental and physical burden of managing T1D with insulin therapy and glucose monitoring, which has a huge impact on quality of life.
This gives families the opportunity to prepare for the mental, physical, and financial impacts of managing T1D. Further, any 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, while time spent without hypoglycaemia (low blood glucose) is time without the fear of severe lows that can cause loss of consciousness and even death.
Delaying progression during childhood also helps to preserve remaining beta cell function for longer and can contribute to a less severe symptoms at clinical diagnosis. This vital development means when stage 3 T1D eventually develops, the condition may be less aggressive and easier to manage.
My sister was diagnosed with T1D in 2017. In 2023, I was screened and tested positive for early signs of T1D. By the end of 2025, I had progressed to stage 2 and at the beginning of 2026, I was able to access teplizumab.
“It was a really positive experience that has given me so much hope that I still have a life to live without T1D for a while. It’s given me back some control, which is so empowering in the face of this condition. I am so grateful for this opportunity, and its one I wish my sister had been able to have as well, to get back some of her childhood.”
– Jess, 19, Tzield recipient
Screening for early-stage T1D
Alongside the more than 145,000 Australians currently living with T1D, an estimated 25,000 people are unknowingly living with the early, pre-symptomatic stages of the condition. The only way to identify people in stage 2 T1D, who may be eligible to receive Tzield, is through screening. Early detection creates a critical window for intervention that can deliver lasting health benefits.
Until recently, identifying early-stage T1D primarily enabled closer monitoring of blood glucose levels to track progression to clinical T1D, alongside education and support for individuals and families. This is vital for reducing the risk of diabetic ketoacidosis (DKA) at diagnosis – a serious and potentially life-threatening complication caused by dangerously high blood glucose levels when stage 3 T1D develops unexpectedly. Experiencing DKA at diagnosis can also negatively affect long-term health outcomes.
Australia is a global leader in T1D screening, thanks to Breakthrough T1D’s long-term investment in screening initiatives nationwide. Most recently, Breakthrough T1D committed almost $10m to support the implementation of general population screening for T1D in Australia. We also fund Type1Screen, which offers free and easy T1D screening for people who already have a family member diagnosed. Combined with the availability of Tzield and other emerging DMTs, screening has the potential to transform how T1D is identified, treated, delayed and managed in Australia.
This is an exciting and important development that represents a new and more effective way to treat type 1 diabetes. This landmark news comes after decades of effort from researchers, clinicians, members of the diabetes community and organisations like Breakthrough T1D. Together, we have been working to develop screening and care pathways that facilitate early diagnosis and identify people who could benefit from Tzield and the many other treatments currently being evaluated in our clinical trial programs.”
– Professor John Wentworth, endocrinologist and Senior Clinical Research Fellow at St Vincent’s Institute of Medical Research
The role of Breakthrough T1D
DMTs mark a major shift for T1D care, moving from treating symptoms after diagnosis toward identifying and intervening earlier in the disease process. These therapies are a key component of Breakthrough T1D’s research portfolio, designed to find cures and improve lives.
Breakthrough T1D has funded the development of teplizumab for over almost 4 decades, from early discovery research to develop the drug, through to the landmark clinical trials that proved it could delay T1D progression. Our sustained funding, advocacy and strategic involvement has ensured Australia is at the forefront of T1D early detection and clinical care, which has enabled therapies such as Tzield to be introduced locally. We will now continue our work to ensure Tzield can be rolled out effectively in Australia by building the necessary infrastructure and awareness in the healthcare system.
Breakthrough T1D is also supporting the development and testing of other DMTs, with 6 clinical trials currently underway in Australia. Promising therapies include baricitinib and anti-thymocyte globulin (ATG), which are both proving effective at delaying T1D progression.
Next steps for Tzield in Australia
Approval by the TGA is the crucial starting point for Tzield to become widely available in Australia. Broader access to the medication is dependent on it being listed on the Pharmaceutical Benefits Scheme (PBS), which comprises medications that are subsidised by the Australian Government. Sanofi has submitted Tzield to the Pharmaceutical Benefits Advisory Committee (PBAC), which recommends what should be listed on the PBS, for consideration at their July meeting.
Breakthrough T1D, with support from the wider T1D community, are advocating for this to ensure Australians have access to this groundbreaking therapy. We will keep our community updated with any information about this.
Today’s announcement brings us one step closer to Breakthrough T1D’s vision of a world without T1D.
Learn more about our research to find cures and improve lives for T1D.
Read more about Tzield
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- A history of Tzield and Breakthrough T1D’s involvement: a drug almost 40 years in the making
- Tzield FAQs: commonly asked questions answered
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