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

The approval is supplement S-041 to NDA 217806. The FDA's letter says the supplement updates the prescribing information to add information from a completed cardiovascular outcomes trial, SURPASS-CVOT, in adults with type 2 diabetes and established cardiovascular disease. It lists two areas of change: the warning on diabetic retinopathy complications, and the patient counselling section, which was aligned with the dosage and administration section ^[1].

The FDA reissued the letter as a corrected approval, signed on 2 September 2026, because the first version had attached out-of-date copies of the Medication Guide and Instructions for Use. The corrected letter keeps the effective date of 26 August 2026 ^[1]. The revised label itself is marked "Revised: 08/2026" ^[2], and DailyMed posted the updated Zepbound listing on 2 September 2026 ^[4]. That is why some sources describe it as the September 2026 label.

In the February 2026 label, the warning on diabetic retinopathy complications in people with type 2 diabetes said that rapid improvement in glucose control has been linked to a temporary worsening of diabetic retinopathy. It added that tirzepatide "has not been studied" in people with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular oedema, and it advised monitoring people with a history of retinopathy ^[3].

In the August 2026 label, the "has not been studied" sentence is gone. The section now says temporary worsening has been reported with rapid improvement in glucose control, and that patients with a history of diabetic retinopathy should be monitored for progression ^[2]. The label's Recent Major Changes box dates this section 08/2026 ^[2]. The monitoring advice is unchanged in substance. What changed is that the label no longer describes these groups as unstudied, which fits the FDA letter's statement that the change was based on SURPASS-CVOT ^[1].

The patient counselling changes are editorial. Instructions about syringes for Zepbound vials were moved within the paragraph on training for each presentation, without new content that we could find by comparing the two versions ^{[2] [3]}. The weight-management and sleep apnoea indications, and the label doses of 5 mg, 10 mg or 15 mg once weekly for weight reduction with 15 mg as the maximum, are the same as before ^[2]. Those are label doses, reported here as information only.

SURPASS-CVOT was published in the New England Journal of Medicine in December 2025. It was a double-blind trial in patients with type 2 diabetes and atherosclerotic cardiovascular disease, comparing weekly tirzepatide (up to 15 mg) with dulaglutide 1.5 mg, a drug already shown to reduce cardiovascular events. The modified intention-to-treat population was 6,586 patients on tirzepatide and 6,579 on dulaglutide ^[5].

The primary end point, a composite of cardiovascular death, heart attack or stroke, occurred in 12.2% of the tirzepatide group and 13.1% of the dulaglutide group: a hazard ratio of 0.92 (95.3% CI 0.83 to 1.01). That met the test for non-inferiority but not for superiority. Adverse events appeared similar overall, with more gastrointestinal events on tirzepatide ^[5].

The same trial produced a bigger change for Mounjaro. On 27 August 2026 the FDA approved supplements S-044 and S-045 to NDA 215866. The letter adds an indication to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack or non-fatal stroke) in adults with type 2 diabetes who are at high risk of these events, based on SURPASS-CVOT, and makes the same retinopathy warning change. S-045 states that the 2.5 mg dose can be used for ongoing glycaemic control ^[6].

So Zepbound tirzepatide and Mounjaro tirzepatide, the same molecule under two brands, now have different labels on this point. Mounjaro carries a cardiovascular risk-reduction indication for people with type 2 diabetes. Zepbound's label update carried only the safety wording. SURPASS-CVOT did not test people with obesity who do not have diabetes, which is Zepbound's main population. Our GLP-1 brand names guide explains how the brands differ.

Yes. Tirzepatide is FDA approved as Mounjaro for type 2 diabetes and as Zepbound for weight management and obstructive sleep apnoea in adults with obesity ^{[2] [6]}. This tirzepatide news concerns those licensed products and their labels. It does not change the status of tirzepatide sold as a research peptide, which the FDA has treated as an unapproved new drug in warning letters to online sellers ^[7]. Our US legal status page covers that position.

For the wider evidence, our tirzepatide guide covers the SURMOUNT and SURPASS trials, and the tirzepatide vs semaglutide comparison sets out the head-to-head data. The cardiovascular result above is against dulaglutide, not semaglutide, and should not be read as a comparison with Wegovy or Ozempic.