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Lilly's Retatrutide: 12-Year Exclusivity Awaits
19 Aug
Summary
- Retatrutide achieves record 28.3% weight loss, surpassing surgery.
- Foundayo offers oral GLP-1 convenience, but lacks outcomes data.
- Lilly secures 12-year exclusivity for retatrutide via BLA pathway.
Eli Lilly has made significant advancements, with its retatrutide candidate achieving a record 28.3% average weight loss in Phase 3 trials. This dual-action drug is slated for a Biologics License Application submission to the FDA in the first quarter of 2027. Regulatory approval is anticipated in late 2027 or early 2028, granting it a 12-year market exclusivity period.
Concurrently, Lilly's oral GLP-1 drug, Foundayo (orforglipron), received approval in the UK on August 10, 2026, offering a convenient alternative to injectables. However, Foundayo has not yet completed a cardiovascular outcomes trial, a factor that may limit its use in high-risk patients.
These pipeline developments follow a record-setting second quarter for Eli Lilly, which saw revenue surge by 48%. The company raised its full-year 2026 revenue guidance to $85 billion to $87 billion, underscoring strong demand for its existing therapies like Mounjaro and Zepbound.
