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Tirzepatide news

Regulator decisions, trial results and approvals involving Tirzepatide, newest first. Each report is dated and cites the official record.

  1. Zepbound label updated in August 2026 after the SURPASS-CVOT heart trial, as Mounjaro gains a cardiovascular indication

    On 26 August 2026 the FDA approved a revision to the US label for Zepbound, the weight-management brand of tirzepatide, using data from the SURPASS-CVOT cardiovascular trial. The change rewrote the diabetic retinopathy warning; it did not add a new Zepbound indication. A day later, Mounjaro, the diabetes brand of the same drug, gained a new indication to reduce the risk of major cardiovascular events.

  2. FDA warns sellers of semaglutide, tirzepatide and retatrutide labelled "for research purposes"

    FDA has sent warning letters to online companies selling semaglutide, tirzepatide and retatrutide with "research use only" labels, most recently on 24 August 2026. In each letter FDA said the labels did not stop the products being unapproved new drugs, because the sellers' own websites showed they were meant for human use. Retatrutide remains unapproved.

  3. Retatrutide phase 3 results so far: one peer-reviewed trial and four company-reported TRIUMPH readouts

    The first peer-reviewed phase 3 trial of retatrutide, TRANSCEND-T2D-1, was published in The Lancet in June 2026. Eli Lilly has also reported topline results from four TRIUMPH obesity trials by press release, most recently on 23 July 2026. Retatrutide is still not approved anywhere, and the head-to-head TRIUMPH-5 trial against tirzepatide is still running.

  4. FDA proposes keeping semaglutide, tirzepatide and liraglutide off the 503B bulks list

    On 30 April 2026 FDA proposed not to add semaglutide, tirzepatide or liraglutide to the 503B bulks list, saying it found no clinical need for outsourcing facilities to compound them from bulk ingredients. The comment period was later extended to 30 July 2026. As of 24 September 2026 we have found no final decision.

  5. SURMOUNT-5: tirzepatide beat semaglutide for weight loss in the first head-to-head obesity trial

    SURMOUNT-5, published online in the New England Journal of Medicine on 11 May 2025, compared weekly tirzepatide with weekly semaglutide in 751 adults with obesity but without diabetes. After 72 weeks, average weight loss was 20.2% with tirzepatide and 13.7% with semaglutide. It is the first randomised trial to compare the two drugs directly for obesity.