Key Facts:
* Tzield is the first new therapy approved for T1D since the discovery of insulin more than 100 years ago.
* Tzield is now approved in Australia to delay the onset of stage 3 (or clinical) T1D - where changes in blood glucose levels have begun but insulin therapy is not yet required.
* The therapy works by targeting the immune attack that causes T1D, delaying progression to clinical diagnosis by an average of two years.
Footage - 19 year old Jess Kovacs receiving Tzield:
Australia has entered a new era in type 1 diabetes (T1D) treatment, with the approval of Tzield® (teplizumab) by the Therapeutic Goods Administration (TGA) marking the first therapy available to delay the onset of clinical T1D.
The landmark approval is a historic moment for the T1D community and the culmination of almost four decades of research funding, advocacy and strategic investment by Breakthrough T1D, the leading non-profit organisation for T1D globally. Their support has played a central role in the development of the therapy, from its earliest stages through to clinical trials, screening initiatives and global advocacy efforts.
Tzield is now approved in Australia to delay the onset of stage 3 (or clinical) T1D in people aged eight years and older with stage 2 T1D – the early, pre-symptomatic stage of the condition, where changes in blood glucose levels have begun but insulin therapy is not yet required.
The therapy works by targeting the immune attack that causes T1D, delaying progression to clinical diagnosis by an average of two years. This gives people valuable time without the daily burden of insulin therapy and glucose monitoring.
It is the first new therapy approved for T1D in more than 100 years – since the discovery of insulin – and represents a major shift in how the condition can be approached, from treating T1D after diagnosis to delaying its progression before symptoms develop.
Breakthrough T1D Australia Chief Executive Officer, Sydney Yovic, said the approval represented a transformational moment for Australians affected by T1D.
"For generations, T1D has only been treated once symptoms appear and insulin therapy becomes essential. Tzield changes that. For the first time, we can intervene earlier in the disease process and delay the onset of stage 3 T1D.
"For families living with T1D, every day without the relentless mental and physical burden of managing the condition matters. Delaying progression means more time without insulin therapy, glucose monitoring, fear of severe hypoglycaemia and the constant decision-making that comes with T1D. Further, it reduces the risk of short- and long-term complications that come with T1D.
"This approval also highlights why screening for early-stage T1D is so important. Tzield can only be beneficial if people are detected in the early stages, before symptoms develop, creating a critical opportunity to intervene earlier and improve long-term health outcomes.
"Breakthrough T1D has spent years investing in screening research and infrastructure across Australia to help make early detection possible. Combined with therapies like Tzield, screening has the potential to completely transform how T1D is identified, delayed and managed in the future.
"Breakthrough T1D is incredibly proud to have helped drive the development of teplizumab over almost 40 years – from the earliest discovery research through to the landmark clinical trials that proved this therapy could delay T1D."
Breakthrough T1D first funded research into teplizumab in 1988, supporting pioneering immunologist Professor Kevan Herold, who has since led multiple clinical trials investigating the therapy. The organisation also funded fellow immunologist Professor Jeffrey Bluestone and invested strategically in companies that helped bring the drug through development and into the global healthcare system.
Beyond funding the therapy itself, Breakthrough T1D has invested heavily in the screening and clinical trial infrastructure needed to identify people in the early stages of T1D and connect them with emerging therapies.
Australia is now recognised as a global leader in T1D screening thanks to long-term investment from Breakthrough T1D, including almost $10 million committed with the goal of implementing population screening initiatives nationwide earlier this year.
Alongside the more than 145,000+ Australians currently living with T1D, an estimated 25,000 people are unknowingly living with the early stages of the condition. Screening is currently the only way to identify people eligible for Tzield before symptoms develop.
Nineteen-year-old Tzield recipient Jess Kovacs, who accessed the therapy after being detected with early stage T1D, said the experience had given her hope for the future.
"My sister was diagnosed with T1D aged 7, 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 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."
While TGA approval is a significant milestone, broader access to Tzield will depend on listing on the Pharmaceutical Benefits Scheme (PBS). Breakthrough T1D will do everything possible to advocate for this outcome.
This news brings us one step closer to Breakthrough T1D's vision of a world without T1D.
