Ozempic gets first-of-its-kind approval for kidney disease in type 2 diabetes (Australia update)

Ozempic gets first-of-its-kind approval for kidney disease in type 2 diabetes (Australia update)

If you’re living with type 2 diabetes, kidney health is probably one of those quiet worries that never quite leaves your mind. The kidneys play a vital role in filtering waste and balancing fluids, and diabetes remains the leading cause of chronic kidney disease (CKD) in Australia.


In 2025, a major update brought new hope: Ozempic (semaglutide) received first-of-its-kind TGA approval to slow kidney disease progression in adults with type 2 diabetes. It’s the first time a GLP-1 receptor agonist has been approved in Australia specifically for protecting kidneys, not just lowering blood glucose.


Why this approval matters

Nearly 38% of CKD cases in Australia are linked to diabetes. Traditional management has relied on blood pressure control, SGLT2 inhibitors, and tight glucose regulation. Ozempic’s new indication adds a fresh layer of protection.

According to the Therapeutic Goods Administration (TGA), the updated approval allows Ozempic to be used as adjunct therapy to standard care for adults with type 2 diabetes and chronic kidney disease, helping reduce the risk of sustained decline in kidney function and cardiovascular death (RACGP, 2025).

It’s not a replacement for other treatments - but it changes what’s possible.


What the evidence shows

The decision was based on the FLOW trial, a large, randomised study published in the New England Journal of Medicine in 2024. Participants with type 2 diabetes and CKD who received semaglutide experienced:


  1. A 24% lower risk of major kidney events (a composite of kidney failure, sustained decline in kidney function, or renal death) compared with placebo
  2. Slower decline in eGFR, a key measure of kidney performance
  3. Reduced albuminuria, meaning less protein leakage into urine
  4. Lower cardiovascular and all-cause mortality


Importantly, the treatment’s safety profile remained similar to previous Ozempic trials - most adverse effects were mild gastrointestinal symptoms that tended to resolve over time.

These findings position Ozempic as a new option alongside existing kidney-protective therapies, but not a replacement for them.


How Ozempic fits into overall kidney protection

Even with Ozempic now approved, standard CKD care remains essential. The medication works best as part of a layered approach, combining lifestyle, blood pressure, and glucose management.

Strategy

Main benefit

Common limitation

Blood pressure control (ACE inhibitors, ARBs)

Slows glomerular damage

May raise potassium or lower renal perfusion

SGLT2 inhibitors

Strong kidney and heart protection

Less effective in advanced CKD

Glycaemic control

Reduces strain on kidneys

Hypoglycaemia risk if over-corrected

Ozempic (semaglutide)

Adds 24% composite risk reduction in major kidney events

Private cost, possible mild nausea

 

Used together, these approaches strengthen kidney outcomes - especially when combined with consistent glucose tracking using a CGM and secure CGM patches that help sensors stay in place through activity, weather, and sleep.


Who may benefit most

Ozempic is suitable for adults with type 2 diabetes and CKD who:

  1. Have moderate CKD (stages 2–4, not yet on dialysis)
  2. Already receive RAAS or SGLT2 inhibitor therapy
  3. Need additional weight and glucose control
  4. Can tolerate GLP-1 therapy and manage private prescription costs

Those with very advanced CKD or on dialysis were not well represented in FLOW, so individual assessment by a nephrologist or endocrinologist is essential. As with any prescription medicine, close supervision and routine kidney tests (eGFR and albuminuria) remain vital.


Is it PBS-subsidised yet?

As of October 2025, there has been no public confirmation of a PBS subsidy for Ozempic’s kidney disease indication. The TGA approval is in place, but patients prescribed Ozempic for CKD protection may still face private costs until a subsidy update is announced.

Ongoing supply issues are reportedly improving, according to the TGA’s latest advisories, but prescribing remains tightly regulated to prioritise approved use in type 2 diabetes.


People also ask


Is Ozempic approved for kidney disease in Australia?

Yes. In August 2025, the TGA approved Ozempic to reduce kidney function decline and cardiovascular risk in adults with type 2 diabetes and CKD.

Does Ozempic help kidney disease?

Evidence from the FLOW trial shows Ozempic reduced the composite risk of major kidney outcomes by around 24% and slowed eGFR decline.

Can Ozempic replace other kidney medications?

No. It complements existing therapies such as SGLT2 inhibitors and ACE inhibitors - it’s an additional layer of protection.

Is Ozempic safe for people with kidney disease?

In studies, Ozempic was generally well tolerated, though mild gastrointestinal effects were common. People with severe CKD or on dialysis should seek specialist advice before use.


Keeping your daily management on track

For anyone managing diabetes and CKD, protecting kidney health goes hand in hand with maintaining steady glucose levels. A continuous glucose monitor (CGM) gives real-time insights into your trends and helps reduce fluctuations.

Small daily habits matter too - ensuring proper skin prep, choosing hypoallergenic CGM patches, and using sensor protection in summer are simple ways to keep your readings accurate and your skin healthy.

 

Moving forward with confidence

The TGA’s approval of Ozempic for kidney disease represents a significant step forward in diabetes care for Australians. It’s proof that medical research continues to evolve, giving patients more ways to protect vital organs and live well for longer.


Still, no medication works in isolation. Real progress happens when treatment, lifestyle habits, and glucose awareness all come together. Reliable CGM support helps you stay connected to what your body is doing, while strong patch adhesion keeps your readings accurate through movement, sweat, and sleep.


For people managing both diabetes and kidney disease, this new approval isn’t just about science - it’s about hope. Every small improvement in your daily management counts towards a healthier, more confident future.


References

Australian Pharmacist (2025) Ozempic now indicated to prevent CKD progression, Australian Pharmacist. Available at: https://www.australianpharmacist.com.au/ozempic-now-indicated-to-prevent-ckd-progression/ (Accessed: 14 October 2025).

RACGP (2025) Ozempic cleared for kidney disease treatment, Royal Australian College of General Practitioners. Available at: https://www1.racgp.org.au/newsgp/clinical/ozempic-cleared-for-kidney-disease-treatment (Accessed: 14 October 2025).

The Australian (2025) First-of-its-kind Ozempic listing for kidney disease. Available at: https://www.theaustralian.com.au/health/medical/firstofitskind-ozempic-listing-for-kidney-disease/news-story/01096da0dbde8732ec786aed425dbb75 (Accessed: 14 October 2025).

TGA (2025) Ozempic (semaglutide) supply information, Therapeutic Goods Administration. Available at: https://www.tga.gov.au/safety/shortages/information-about-major-medicine-shortages/ozempic-semaglutide-supply-information (Accessed: 14 October 2025).

Mann, J.F.E. et al. (2024) ‘Effects of once-weekly semaglutide on kidney outcomes in type 2 diabetes’, New England Journal of Medicine, 391(10), pp. 2041–2053. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2403347 (Accessed: 14 October 2025).

Novo Nordisk (2025) Ozempic (semaglutide) official website. Available at: https://www.ozempic.com/ (Accessed: 14 October 2025).

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