Understanding TGA approval
TGA (Therapeutic Goods Administration) approval means a medication has undergone rigorous review of its safety, efficacy, and manufacturing quality by Australia's national regulatory body. Only TGA-approved medications can be legally prescribed in Australia.
TGA approval for "weight management" specifically means the medication has been studied in clinical trials for weight loss and has demonstrated meaningful results with an acceptable safety profile. This is distinct from medications approved for other conditions (like diabetes) that also happen to cause weight loss.
What about off-label use?
Doctors can legally prescribe medications "off-label" — for conditions they're not specifically approved for. However, since October 2024, off-label Ozempic prescriptions for weight loss are restricted. The TGA has also banned compounded GLP-1 medications. These restrictions mean the approved indications now matter more than ever for access.
Medications in the pipeline
Several medications are in late-stage clinical trials that may eventually receive TGA approval for weight loss in Australia:
- Oral semaglutide (high-dose): Approved in the US. TGA submission expected 2026–2027.
- Retatrutide: Triple agonist showing ~24% weight loss in Phase 3 trials. Earliest TGA approval: 2027–2028.
- Orforglipron: Oral GLP-1 agonist. Phase 3 trials ongoing.
- Survodutide: Dual GLP-1/glucagon agonist. Phase 3 data pending.
This page will be updated as new medications receive TGA approval.
Browse all current medications →