When will retatrutide be approved?

No approval date for retatrutide exists as of 23 September 2026. Eli Lilly said in its release of 23 July 2026 that it plans a US Biologics License Application submission in Q1 2027. The FDA then reviews the file, so any approval would come after that, and Philippine registration would need a separate application.

Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.

Updated 23 September 2026

The sponsor's stated plan

The regulatory dataset records the next milestone as: "Sponsor plans a US Biologics License Application submission in Q1 2027". The source is Eli Lilly press release dated 23 July 2026, read on 23 September 2026.

A Biologics License Application is the file a sponsor submits to ask the US FDA for approval. Submission starts a review; it does not grant anything, and the review can end in approval, a request for more data, or refusal.

Trials that have reported and trials still running

5 completed retatrutide trials are on the Research Desk: TRIUMPH-1, TRIUMPH-2, TRIUMPH-3, TRIUMPH-4, Retatrutide phase 2 (Jastreboff). Their results are summarised, with adverse events, on the Trial Explorer.

6 phase 3 trials are listed as ongoing on ClinicalTrials.gov: TRIUMPH-5 (NCT06662383), TRIUMPH-6 (NCT06859268), TRIUMPH-7 (NCT07035093), TRIUMPH-8 (NCT07232719), TRIUMPH-9 (NCT07357415), TRIUMPH-OUTCOMES (NCT06383390). None has published results.

The Philippines

An approval in the United States would not register retatrutide in the Philippines. Registration is a separate application to FDA Philippines, and its current record for retatrutide could not be read: the FDA Philippines verification portal search timed out on 23 September 2026, retried the same day in a browser with the same result.

How to follow it

A filing, a regulatory decision and a Philippine registration are three separate events, and each will be recorded with its own date on the Regulatory Status Tracker when it happens. The Trial Explorer adds each running TRIUMPH trial's results once the sponsor or the trial paper publishes them, with the adverse events beside the outcome.

This is general information, not legal advice.

Sources

Where every figure comes from

Eli Lilly press release, 23 July 2026 · checked 23 September 2026
ClinicalTrials.gov NCT06662383 · checked 23 September 2026
ClinicalTrials.gov NCT06859268 · checked 23 September 2026
ClinicalTrials.gov NCT07035093 · checked 23 September 2026

Last reviewed 23 September 2026