Lilly pulls US heart failure application for tirzepatide after FDA seeks another trial
Lilly withdrew its bid to add a heart-failure indication to tirzepatide after the FDA asked for another trial, so patients with obesity and HFpEF have no such label on the drug.
Eli Lilly has withdrawn its US application to add a heart failure indication to tirzepatide, the drug it sells as Zepbound, after the FDA said another confirmatory trial would be needed [1].
The application covered heart failure with preserved ejection fraction, or HFpEF [1]. Lilly's chief scientific officer, Dan Skovronsky, told investors about the pullback during a briefing on May 1, 2025; the news surfaced publicly on May 3 [1].
Skovronsky said the company still thinks its phase 3 SUMMIT trial supports the indication, but that the FDA wanted more than one study behind it: "FDA indicated an additional confirmatory clinical trial is required" [1]. He added that reviews of the heart failure use continue in other countries [1]. The SUMMIT findings were published in a medical journal, and the briefing did not include the trial's effect sizes, so how large the benefit was for patients has not been disclosed in these accounts [1].
He called SUMMIT "a study with a really strong and profound benefit for patients" [1]. Whether Lilly will refile is unclear. Data from other trials could support a resubmission, he said, but he questioned the incentive: everyone who would have qualified for the heart failure label is already covered by the obesity approval, making the heart failure use "a new benefit for people that might already be understood to doctors today" rather than a new population [1].
The company is not the first to hit this wall. Novo Nordisk withdrew its HFpEF application for Wegovy, its brand of semaglutide, in 2024 and sent it back in 2025, adding a pooled analysis of heart failure outcomes from four earlier studies [1]. As of May 2025, semaglutide looked likely to win that approval later in the year [1]. What the FDA ultimately decided has not been reported.
Skovronsky also warned that the extra-trial requirement could chill research more broadly, saying it "could have a curtailing effect on investments in HFpEF," which he described as "a pretty serious unmet medical need" [1].
In Europe, regulators reached a different and split outcome. On January 30, 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use declined to back Mounjaro, the tirzepatide brand sold in Europe, for a type of heart failure, while endorsing Novo Nordisk's Kayshild for liver disease [2]. The committee's reasons for the heart failure decision have not been reported.
Why it matters for patients
People who have both obesity and HFpEF do not have an FDA-approved heart failure indication for tirzepatide [1]. How much a separate label would have changed insurance coverage, prior authorization or the way clinicians explain the drug's heart benefits has not been disclosed [1].
Lilly's stated view is that no patients lose access, since the obesity indication already reaches the same group [1]. The heart failure use, in that framing, is an added benefit for people already eligible for treatment rather than a route to treatment for a new group [1].
The larger worry Skovronsky raised is about what gets studied. If large outcome trials in a population already covered by an obesity approval offer little commercial upside, companies may run fewer of them, and HFpEF — described as a serious unmet need — is the condition that would lose out [1].
No change to the existing obesity approval was announced, and the withdrawal did not alter what tirzepatide is cleared to treat in the US [1].
What happens next
Lilly says heart failure reviews are ongoing in other countries but has not identified them or given timelines [1].
A US resubmission is possible but unannounced [1].
For semaglutide, the refiled HFpEF application was expected to be decided in 2025; that outcome has not been reported [1].
The European heart failure question for Mounjaro was answered against Lilly on January 30, 2026, and the reasons were not disclosed [2].
Sources
Semaglutides.org provides information only, not medical advice. Talk to a licensed provider about your own care before making changes. Some telehealth links are affiliate links and are labeled where they appear.