Regulatory update
FDA guidance on unapproved retatrutide: what the current statement says
The FDA states that retatrutide is not a component of an FDA-approved drug and has not been found safe and effective for any condition.
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Research news and updates
Source-led articles, research summaries and dated updates.
Regulatory update
The FDA states that retatrutide is not a component of an FDA-approved drug and has not been found safe and effective for any condition.
Read the FDA statementPeer-reviewed analysis
A post hoc analysis of Phase 2 trials found reductions in atherogenic lipoproteins and inflammatory biomarkers. The findings are encouraging, but biomarker changes do not establish cardiovascular outcomes.
View the PubMed recordSponsor-reported results
Lilly announced Phase 3 topline results from two trials and said detailed results would be presented and published later. Retatrutide remains investigational.
Read the Lilly announcementResearch programme
Lilly outlined Phase 3 retatrutide presentations planned for the American Diabetes Association's 2026 Scientific Sessions. This is sponsor-reported information, not regulatory approval.
Read the Lilly announcementSponsor-reported results
Lilly reported an average body-weight reduction of 28.3% at 80 weeks in the highest studied group. These are sponsor-reported topline findings; retatrutide remains investigational.
Read the Lilly announcementPeer-reviewed trial
The peer-reviewed trial reported a 24.2% mean reduction at 48 weeks in the highest studied group, compared with 2.1% for placebo. Gastrointestinal adverse events were the most common and were dose-related.
View the peer-reviewed abstractPeer-reviewed trial
In adults with type 2 diabetes, the trial reported clinically meaningful improvements in glycaemic control and robust body-weight reductions, helping inform the Phase 3 programme.
View the peer-reviewed abstract