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Retatrutide-Diabetes
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.
Is retatrutide available in the consumer market?
Retatrutide is a phase 3 investigational agent. Lilly is providing retatrutide only to participants in Lilly‑sponsored clinical trials. At this time, any sale for human use is unlawful.
Content Overview
- Is retatrutide being compounded?
- When will retatrutide be available in the consumer market?
- References
Is retatrutide being compounded?
According to the U.S. Food and Drug Administration, retatrutide cannot be lawfully compounded.1 Eli Lilly and Company (Lilly) is the only lawful proprietor of retatrutide, which is an investigational molecule. Lilly is only supplying to participants in Lilly-sponsored clinical trials. Any products for sale claiming to be retatrutide are unlawful, may expose patients to potential serious health risks, and should not be taken.
Anyone who believes they received or used retatrutide outside of a Lilly-sponsored clinical trial should contact Lilly via the local customer channels.
For more information on counterfeit or illegally compounded retatrutide, you may visit https://www.lilly.com/safety/real-medicine or contact your local Lilly medical information.2
For information and updates on retatrutide trials please refer to Lilly.com or Clinicaltrials.gov.
When will retatrutide be available in the consumer market?
Lilly plans to submit a Biologics License Application (BLA) for retatrutide to the U.S. Food and Drug Administration in the first quarter of 2027, following completion of a comprehensive Chemistry, Manufacturing, and Controls (CMC) data package.3 Retatrutide is an investigational molecule that cannot be legally sold or marketed for human use.1,3
To date, retatrutide remains an investigational molecule. It has not been approved by the FDA or any other regulatory authority, and there is no guarantee that it will receive regulatory approval or that any anticipated submission timeline will be met.3
References
- FDA's concerns with unapproved GLP-1 drugs used for weight loss. U.S. Food and Drug Administration Website. Issued April 4, 2026. Accessed May 6, 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- Protect yourself against counterfeit, fake, and unsafe or untested compounded products. Eli Lilly and Company. Accessed July 17, 2024. https://www.lilly.com/safety/real-medicine
- Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C. News release. Eli Lilly and Company. July 23, 2026. Accessed July 23, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-successful-two-additional
Date of Last Review: July 23, 2026