Research material and lot documents.
Retatrutide FDA approval status: Eli Lilly's page of September 29, 2026 says that retatrutide "is not currently approved by the FDA and is considered an investigational medication." Quoted text is exact and appears in italics, with its source named beside it.
Lilly's page "What to know about retatrutide," dated September 29, 2026, answers the question "Is retatrutide approved by the FDA?" with this text: No. Retatrutide is not currently approved by the FDA and is considered an investigational medication. Lilly is currently evaluating its safety and efficacy in clinical trials. It also states: Retatrutide has not been approved by any regulatory agency (the sentence continues in the source). Source: Lilly, What to know about retatrutide.
Lilly gives no launch date. The retatrutide trials page lists the trials that Lilly's statement refers to. Lilly's page of September 29, 2026 says: Retatrutide is currently in Phase 3 clinical trials and launch will depend on the completion of these trials and the regulatory approval process.
Lilly's news release of July 23, 2026 says: Lilly plans to submit a Biologics License Application (BLA) for retatrutide to FDA in Q1 2027. Later in the release: Lilly is completing the comprehensive Chemistry, Manufacturing, and Controls (CMC) data package required for a Biologics License Application (BLA) and plans to subsequently submit retatrutide in Q1 2027 for U.S. approval. Source: Lilly news release of July 23, 2026.
Lilly's medical information page, last reviewed August 4, 2026, adds: 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. Source: Lilly Medical Information, Is retatrutide available in the consumer market?.
FDA's page "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss," content current as of October 1, 2026, includes this text: Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition.
The same page says: FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide that are falsely labeled “for research purposes” or “not for human consumption.” These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to their health.
Source for both quotations: FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.
FDA's substance registration record for retatrutide (UNII NOP2Y096GV) carries this note: UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Source: FDA UNII record for retatrutide.
ClinicalTrials.gov lists an Eli Lilly record, Pre-approval Expanded Access of Retatrutide (LY3437943), with the status "Available" and a last update posted on August 6, 2026. The record describes single-patient expanded access for adults with severe obesity who have at least two serious or life-threatening obesity-related complications, are refractory to the best approved therapy and are unable to join a retatrutide trial.
Tirzepatide, which activates the GIP and GLP-1 receptors, is FDA approved as Mounjaro and Zepbound. Source: FDA announcement, November 8, 2023. The retatrutide vs tirzepatide page compares the trial records for both molecules.