Eli Lilly's experimental weight-loss shot retatrutide did not increase heart risk in a study. The company will seek FDA approval early next year, later than some expected.
Eli Lilly & Co. said its experimental weight-loss shot retatrutide did not increase overall cardiovascular risk in a trial of patients with obesity and heart disease. Lilly said the result addresses earlier concerns over possible heart rhythm abnormalities flagged in prior studies.
A separate study in patients with obesity and diabetes also supported the drug's profile, the company said.
Lilly plans to file for U.S. approval early next year, the company said Thursday. Some Wall Street analysts had expected a filing by the end of 2026.
The company is using a Biologics License Application path, typically reserved for vaccines and gene therapies. The BLA requires additional manufacturing data, Lilly said.
If approved as a biologic, retatrutide would face longer exclusivity before government price negotiations and stronger protection against generic competition.
Lilly Chief Scientific Officer Daniel Skovronsky called retatrutide "the first triple agonist, a medicine that acts on three pathways at once."
BMO Capital Markets analyst Evan Seigerman said the data read positively for the drug's efficacy and benefit-risk profile. He added that the limited cardiovascular event dataset could raise questions ahead of a dedicated heart outcomes study Lilly is running.
Lilly has argued in federal court that retatrutide should be classified as a biologic. Federal law defines biologics as proteins with more than 40 amino acids. Retatrutide has a backbone of 39 amino acids plus a side chain. Last year a judge ordered the FDA to reconsider, a partial win for Lilly.
Analysts project nearly $16 billion in annual sales by 2036. Black-market versions have already appeared.
The drug's progress also puts pressure on Novo Nordisk A/S, which is developing its own next-generation obesity treatments.
Lilly's shares were down less than 1% in premarket trading Thursday.
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