When Will Retatrutide Be Available in Australia?

This article will be updated as and when new information is made available.

So you don’t have to scroll through paragraphs of SEO blog spam, our best estimate for retatrutide availability in Australia is early 2029 for obesity. Drug approval in Australia can take anywhere from 12 to 24 months, but timeframes can be shorter if there’s a strong public interest in expediting the review process. Let’s take a closer look at semaglutide (WeGovy, Ozempic and Zybelsus) and tirzepatide (Mounjaro and Zepbound) approval by the TGA: we believe these timelines assist greatly in estimating retatrutide’s most likely approval timeline.

Semaglutide’s approval process

The earliest date Novo Nordisk approached the TGA regarding a semaglutide product was on the 3rd of October, 2018. This was via the ARTG and specific to 0.25/0.5 mg semaglutide pens (Ozempic) and notably, only for diabetes. The registration for Ozempic was finalized on August 28th, 2019. The public assessment report (PAR) for Ozempic was published on October 30th, 2020 – this is when semaglutide was first made available in Australia, 24 months after Novo Nordisk initiated the application.

Another application, this time for semaglutide as a weight loss drug, was submitted by Novo Nordisk on the 3rd of January, 2023. This covered five pens with quantities of 0.25/0.5/1/1.7/2.4 mg. Note that initial evaluation for Wegovy actually began on the 31st of March, 2021 according to the TGA, but this didn’t specify proposed application methods or dosages. The PAR and approval of Wegovy was published on September 4th, 2024 – 20 months after Novo Nordisk initiated the application.

WeGovy was also approved for risk reduction of major adverse cardiovascular events in December 2024.

Tirzepatide’s approval process

Eli Lilly submitted its dossier for first round evaluation on January 14th, 2022. It was registered on the ARTG December 23rd, 2022 and specific to treatment of type 2 diabetes. This covered 6 pens with quantities of 2.5/5/7.5/10/12.5/15 mg. The PAR and approval of Mounjaro (tirzepatide for diabetes) was published on November 13th, 2023. This is when tirzepatide was first made available in Australia – 22 months after Eli Lilly initiated the application.

Just two weeks after Wegovy was approved for weight loss, Eli Lilly received approval via a PAR for tirzepatide as a weight loss drug. Alongside the standard pre-filled pens, Mounjaro was also made available via injection vials and KwikPens. The submission dossier was submitted on October 3rd, 2023 with final approval granted on September 20th, 2024 – 12 months after Eli Lilly initiated the application.

Mounjaro was also approved for sleep apnoea in adults with obesity in June 2025.

What this means for retatrutide in Australia

Retatrutide is still undergoing multiple phase 3 clinical trials, the biggest of which is TRIUMPH-3. Eli Lilly is the sponsor (no surprises there) and it began back in May 2023. Around 1800 adults were enrolled across multiple countries with completion expected in May 2026. All participants have severe obesity (a BMI of 35 or more) as well as at least one cardiovascular disease. The study is specifically focused on weight loss and cardiovascular event mitigation. In total, 19 research facilities across Australia are involved in the trials.

TRIUMPH-5 is another study that’s directly comparing tirzepatide against retatrutide for weight loss: this began in November 2024 and should be completed in December 2026. Around 800 adults are expected to participate in the trial, although no recruitment in Australia took place.

Eli Lilly may submit its dossier for first round evaluation after TRIUMPH-3 (pending positive outcomes), so at the earliest, late 2026 seems like a realistic estimation, if not later into early 2027 after TRIUMPH-5 has finished. Given an average application-to-approval timeframe of 22 months, we’d say that March 2029 seems about right, given all of the available evidence.

Note that retatrutide has been developed and studied specifically for obesity: the primary application to the TGA will be for weight loss and not for diabetes. A global shortage of semaglutide took place between 2022 and 2024, owing to extensive off-label usage of Ozempic for obesity. Given phase 2 clinical trial results of retatrutide for weight loss, Eli Lilly should hopefully be preparing itself for extreme levels of demand.

Obesity Evidence Hub estimates that by 2030, the total economic cost of obesity will weigh in at roughly $62 billion AUD. Aus Aminos therefore urges the TGA to expedite approval of retatrutide, pending efficacy and side effect trade-offs, to the best of its ability.