LLY's Mounjaro Gets FDA Nod to Cut Cardiovascular Risk in Diabetes

The FDA has approved Eli Lilly’s LLY Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type II diabetes (T2D).

The new indication includes patients with T2D who are at high risk for major adverse cardiovascular events (MACE), such as cardiovascular death, non-fatal heart attack and non-fatal stroke. Mounjaro is already approved, alongside diet and exercise, to improve blood sugar control in adults and children aged 10 years and older with T2D.

Mounjaro’s Label Extension Backed by Cardiovascular Study Data

The latest FDA nod was based on results from a phase III cardiovascular outcomes study (SURPASS-CVOT) that directly compared Mounjaro with Lilly’s GLP-1 RA, Trulicity (dulaglutide), which has established cardiovascular benefit. The study enrolled 13,299 adults with T2D and established atherosclerotic cardiovascular disease, who were randomized equally to receive either Mounjaro (15 mg or the maximum tolerated dose) or once-weekly Trulicity (1.5 mg), with a median follow-up of 210.1 weeks.

Trulicity was an appropriate comparator because it already had proven cardiovascular benefits in patients with T2D. The primary objective was to determine whether Mounjaro was non-inferior to Trulicity in reducing MACE-3, defined as cardiovascular death, heart attack or stroke. The study found that Mounjaro met the non-inferiority objective, supporting its ability to provide cardiovascular protection comparable to an established GLP-1 therapy.

Mounjaro recorded an 8% lower rate of MACE-3 versus Trulicity, with a hazard ratio for time to first MACE of 0.92. However, superiority over Trulicity was not established. The safety and tolerability profile remained broadly consistent with Mounjaro’s established profile, with gastrointestinal events among the most common adverse reactions and generally concentrated during dose escalation.

Shares of Eli Lilly have gained 9.3% year to date compared with the industry’s 13.9% growth.

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LLY Narrows Mounjaro’s Indication Gap With NVO’s Ozempic

The expanded indication strengthens Lilly’s position in the cardiometabolic market while adding another clinically important benefit to Mounjaro’s existing glucose-control and weight-loss profile. It also broadens the pool of patients who may be eligible for the drug, potentially creating another avenue for sustained prescription growth.

The commercial opportunity is significant given Mounjaro’s already rapid growth. Lilly reported worldwide Mounjaro revenues of $18.6 billion in the first half of 2026, up 106% year over year. The product generated $9.9 billion in the second quarter alone (up 91%), reflecting continued demand across U.S. and international markets. The latest cardiovascular indication expands the eligible patient population and could provide an additional sales catalyst in the coming quarters.

The approval is also part of Lilly’s effort to narrow the indication gap with rival Novo Nordisk’s NVO blockbuster GLP-1, Ozempic (injectable semaglutide). NVO’s Ozempic is approved for T2D patients with established cardiovascular disease to reduce MACE and separately for adults with T2D and chronic kidney disease to reduce the risk of sustained kidney-function decline, end-stage kidney disease and cardiovascular death. Ozempic therefore retains an edge in the breadth of its established cardiovascular and kidney-related indications.

Still, LLY’s Mounjaro has captured substantial momentum in the diabetes market. Novo Nordisk reported adjusted first-half 2026 Ozempic sales of $9.21 billion (or DKK 59.2 billion), down 2% at constant exchange rates, with U.S. sales declining 6% as lower realized prices and weaker volumes weighed on performance, although international sales rose 8%. The contrasting trends highlight Mounjaro’s expanding commercial momentum as Lilly adds cardiovascular-risk reduction to its label.

Eli Lilly and Company Price and Consensus

Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote

Zacks Rank and Stocks to Consider

Eli Lilly currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are AC Immune ACIU and Aldeyra Therapeutics ALDX, carrying a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 15.6% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

Over the past 30 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.4% year to date.

Aldeyra Therapeuticsbeat earnings in each of the trailing four quarters, delivering an average surprise of 29.25%.

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