Retatrutide: Lilly Plans to File in Early 2027, and Offers Single-Patient Access Before Then
Published: September 30, 2026 · 3 min read · By Grey Peptides News Desk · ✓ Sourced
Retatrutide, Lilly's once-weekly GIP, GLP-1 and glucagon receptor agonist, is still not approved anywhere. Lilly said on August 5, 2026 that its clinical data package is complete to support registrations for obesity, obstructive sleep apnea and knee osteoarthritis pain, and that it plans to submit its application to FDA in the first quarter of 2027. Until then, the only legitimate way to receive it outside a trial is a narrow, single-patient expanded-access program listed since June 5.
The filing plan
Lilly's second-quarter results, released on August 5 and filed with the SEC, report positive data from three more phase 3 trials of retatrutide in obesity and say the data package now supports registrations for three uses: obesity, obstructive sleep apnea and knee osteoarthritis pain. The company plans to submit to FDA in the first quarter of 2027; its release calls the submission a Biologics License Application. A filing starts a review; it is not an approval, and no date for an FDA decision can be known until the application is in.
Expanded access before approval
Since June 5, ClinicalTrials.gov has listed Lilly's pre-approval expanded-access program for retatrutide as available (NCT07629401, last updated August 6). It is single-patient access, and the criteria are narrow. A patient must be an adult with obesity that has stayed at a BMI of 35 or more despite adhering to and tolerating the highest available dose of an approved weight-management medicine; have two or more serious or life-threatening obesity-related complications already under standard care; be unable to join a retatrutide trial, because of the trial criteria or because no enrolling site is reasonably close; and have discussed every standard option, including bariatric surgery, through shared decision-making. A medical contraindication rules a patient out.
That describes a small group: people for whom the approved medicines have failed and who are seriously ill. It is not a route to retatrutide for general weight loss, and our retatrutide hub sets out how it differs from the trials.
What has not changed
Anything sold online as retatrutide, including vials labelled "GLP-3 RT", is not Lilly's drug and has not been checked by anyone on the buyer's behalf. FDA's August 24 warning letters named retatrutide among the unapproved drugs five online sellers were offering. The trial results are in our TRIUMPH-1 report and the encyclopedia entry.
Related on Grey Peptides
Trials, filing timeline and every legitimate way to get it, dated at source. FDA's letters to five peptide sellers
Retatrutide was among the unapproved drugs named. Retatrutide encyclopedia entry
The phase 2 and phase 3 evidence, study by study.
Record first posted June 5, 2026 and last updated August 6, 2026, read September 30, 2026. Filing plan from Lilly's second-quarter results release of August 5, 2026, as filed with the SEC.