Every comparison of these two brands reaches for the same thing: which one lowers blood sugar more, or which one takes off more weight. That question is about molecules, it has been measured, and it is covered at the molecule level on our tirzepatide vs semaglutide page.
The brands are a different subject, and on the brand question the labels turn out to be more interesting than the trials. Mounjaro and Ozempic are the type 2 diabetes names of tirzepatide and semaglutide — the same molecules sold for weight management as Zepbound and Wegovy, which we compare on their own page. Read side by side, the two diabetes labels carry a claim written in nearly identical language and supported by two entirely different kinds of evidence — and each one describes a population that is not the population its own trial enrolled.
All labels below were read on 13 September 2026 from DailyMed, the National Library of Medicine's index of current FDA labelling. Nothing here is medical advice, and nothing here is a dose or a schedule; our editorial standards explain why.
What each brand is approved to treat
| Mounjaro | Ozempic (injection) | Ozempic (tablet) | |
|---|---|---|---|
| Glycaemic control in adults with type 2 diabetes | Yes | Yes | Yes |
| Glycaemic control in patients aged 10 and older | Yes | — | — |
| Reduction of major adverse cardiovascular event risk | Yes — adults at high risk of those events | Yes — adults with established cardiovascular disease | Yes — adults at high risk of those events |
| Reduced risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in chronic kidney disease | — | Yes | — |
Mounjaro label version 40, published 2 September 2026. Ozempic injection version 20, published 10 June 2026. Ozempic tablet, labelled with Rybelsus, version 14, published 19 August 2026.
Counted plainly, that is three indications to two, and the one Ozempic holds alone is the kidney indication. But counting is the least informative thing that can be done with this table.
The heart claim: same words, opposite mismatches
Both brands say they reduce the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke. Both are describing a three-part composite outcome measured the same way. What differs is who the sentence covers — and in each case, the sentence disagrees with the trial underneath it.
Mounjaro's indication is wider than its trial. The label indicates Mounjaro "to reduce the risk of major adverse cardiovascular (CV) events … in adults with type 2 diabetes mellitus who are at high risk for these events." The trial is SURPASS-CVOT (NCT04255433), and the label's own section heading for it reads "Cardiovascular Outcomes Trial of MOUNJARO in Adults with Type 2 Diabetes Mellitus and Established Cardiovascular Disease." Eligible patients had established cardiovascular disease, were 40 or older, and had an HbA1c between 7.0% and 10.5%. Sixty-five per cent had coronary artery disease, 47% a prior heart attack, 19% a prior stroke. "At high risk" is a larger category than that.
Ozempic's indication is narrower than its trial. The label indicates Ozempic for adults with type 2 diabetes "and established cardiovascular disease." SUSTAIN 6 (NCT01720446) enrolled 3,297 patients, of whom 562 — 17% — had cardiovascular risk factors without established cardiovascular disease or chronic kidney disease. Those patients were in the trial; they are outside the indication.
So two labels covering the same outcome in the same drug class run the mismatch between indication text and trial population in opposite directions. Neither is an error. Indication wording is negotiated with the regulator and reflects what the totality of evidence is judged to support, not a transcription of an enrolment form. But anyone reading the two sentences as though they were interchangeable descriptions of the same kind of patient is reading something the documents do not say.
And the two claims are not the same kind of claim
This is the difference that a table of indications cannot show.
| SUSTAIN 6 (Ozempic) | SURPASS-CVOT (Mounjaro) | |
|---|---|---|
| Comparator | Placebo | Dulaglutide 1.5 mg, an active GLP-1 receptor agonist |
| Patients | 3,297 | 13,299 |
| Follow-up | Minimum 2 years | Median 210.1 weeks |
| Result | Significantly reduced major adverse cardiovascular events | Hazard ratio 0.92 (95.3% CI 0.83–1.01) |
| What the label says | Reduced the occurrence of MACE | Non-inferior; "Superiority to dulaglutide was not established" |
Semaglutide beat a placebo. Tirzepatide matched a drug that had already beaten a placebo, and did not beat it. Both outcomes support an indication, and the second is a harder trial to run and a more clinically realistic question — nobody with established cardiovascular disease and diabetes is left untreated today, which is why active-controlled designs have become the norm. It is still not the same sentence as "better than nothing," and the indication wording gives no sign of the difference.
The confidence interval is worth one line of its own. At 0.83 to 1.01 it very nearly excludes 1.0, in 13,299 patients over roughly four years. A trial that large, landing that close, is evidence of something small rather than evidence of nothing — and the label reports it as non-inferiority because that is what the pre-specified analysis was designed to conclude.
What each holds alone
Ozempic holds the kidney indication. FLOW (NCT03819153) randomised 3,533 adults with type 2 diabetes and chronic kidney disease — mean eGFR 47, median urine albumin-to-creatinine ratio 568 mg/g, 95% already on an ACE inhibitor or ARB — to semaglutide or placebo for a median of 41 months. The composite of sustained eGFR decline of 50% or more, kidney failure, renal death and cardiovascular death occurred less often on semaglutide: hazard ratio 0.76, 95% CI 0.66 to 0.88, p=0.0003. That is a placebo-controlled superiority result in a population already on standard kidney protection.
No equivalent trial has been reported for tirzepatide. The absence of a Mounjaro kidney indication says nothing about the molecule; it says a trial has not been run and read out.
Mounjaro holds the paediatric indication. Its glycaemic indication covers patients from age 10; Ozempic's label is adults only. This is the exact reverse of the position in weight management, where the Wegovy injection reaches patients aged 12 and over and Zepbound does not. Same two molecules, two pairs of brands, and the adolescent door is on opposite sides of the pair depending on which disease is being treated.
The head-to-head, and the dose that dates it
There is one trial in which patients were randomised to one of these molecules or the other for diabetes. SURPASS-2 (NCT03987919) added tirzepatide at three doses or semaglutide 1 mg to metformin in 1,879 adults for 40 weeks.
| At week 40 | Semaglutide 1 mg | Tirzepatide 5 mg | 10 mg | 15 mg |
|---|---|---|---|---|
| HbA1c change (percentage points) | −1.9 | −2.0 | −2.2 | −2.3 |
| Difference vs semaglutide | — | −0.2 | −0.4 | −0.5 |
| Weight change (kg) | −5.7 | −7.6 | −9.3 | −11.2 |
| Difference vs semaglutide | — | −1.9 | −3.6 | −5.5 |
| Reaching HbA1c below 7% | 79% | 82% | 86% | 86% |
The direction is consistent and the two larger HbA1c differences were significant after adjustment for multiplicity. Three things limit it, and the third is specific to this pair:
It was open-label with respect to which drug a patient received, blinded only to the tirzepatide dose assignment. It was funded by tirzepatide's manufacturer, which is ordinary for a registration trial and is still a fact about who designed and analysed it. And the comparator dose is no longer the comparator brand's ceiling: the trial used semaglutide 1 mg, and Ozempic's label describes a 2 mg step above it. Whatever the gap between these molecules is at each brand's top of range, SURPASS-2 did not measure it.
That last point is not a technicality. It is the same structural problem as the obesity head-to-head, where the semaglutide arm could finish below its approved weight-management dose — a trial can be the only direct evidence available and still not be a test of the comparison people think they are reading about.
What this page does not answer
It does not say which drug anyone should take, and it contains no dose and no schedule. Approved strengths appear above only as trial arms, because that is what they were in the documents cited.
It also does not price them. Both manufacturers publish self-pay offers rather than list prices, and the terms attached matter more than the headline; those are worked through, with the dates they were read, on our Mounjaro and Ozempic cost pages, and the whole category's table sits on the cost hub. What a plan will pay for turns on which indication a prescription is written under, which is the mechanism our insurance coverage page sets out.
What it does establish is that the two brands are not the same claim in two boxes. One carries a kidney indication proven against placebo and no paediatric approval; the other reaches children and rests its heart claim on matching a competitor rather than beating a placebo. Both of those facts are readable from a label, and neither appears in the comparison most readers are given.
Sources
- DailyMed, MOUNJARO (tirzepatide) injection / MOUNJARO KwikPen, Eli Lilly and Company. SPL version 40, published 2 September 2026 — read 13 September 2026. Indications, SURPASS-2 and SURPASS-CVOT results, paediatric approval.
- DailyMed, OZEMPIC (semaglutide) injection, solution, Novo Nordisk Pharmaceutical Industries, LP. SPL version 20, published 10 June 2026 — read 13 September 2026. Indications, SUSTAIN 6 and FLOW results.
- DailyMed, OZEMPIC (oral semaglutide) tablet / RYBELSUS (oral semaglutide) tablet, Novo Nordisk Pharmaceutical Industries, LP. SPL version 14, published 19 August 2026 — read 13 September 2026. The tablet's indication wording.
- ClinicalTrials.gov registrations read 13 September 2026: SURPASS-CVOT (NCT04255433), SURPASS-2 (NCT03987919), SUSTAIN 6 (NCT01720446), FLOW (NCT03819153).
- Prices are not re-derived here; they are carried from our Mounjaro and Ozempic cost pages with the dates on which each figure was read.
Labels in this category are revised often, and an indication can widen between one version and the next. Every claim above is tied to a named label version and the date it was read.