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Eli Lilly's TRIUMPH-4 just delivered 28.7% weight loss — the highest in any Phase 3 GLP-1 trial. NDA submission is expected Q4 2026 / Q1 2027. We'll email you within hours of the FDA decision.[1]
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Five stages between Eli Lilly's lab and your local pharmacy. We'll alert subscribers at every transition.
Current approval process status
Phase 1
Completed · 2022
Initial safety validated
Phase 2
Completed · 2023
~24% loss in 48 weeks
Phase 3 (TRIUMPH)
IN PROGRESS · 2026
TRIUMPH-4: 28.7% loss
NDA Submission
Estimated · Q4 2026 / Q1 2027
Eli Lilly files with FDA
FDA Approval
Estimated · 2027–2028
Commercial availability
Phase 1 · Completed (2022)
Initial safety validated.
Phase 2 · Completed (2023)
~24% loss at 48 weeks (NEJM).
Phase 3 (TRIUMPH) · IN PROGRESS
TRIUMPH-4 reported 28.7% mean loss — highest ever in a Phase 3 obesity trial.
NDA Submission · Pending
Estimated Q4 2026 / Q1 2027.
FDA Approval · Pending
Estimated 2027–2028.
Estimated dates are projections based on Eli Lilly public statements and historical FDA review patterns. Not guarantees. Subject to clinical results and regulatory review timeline.
We don't write a weekly newsletter. We write when the FDA pipeline moves.
TRIUMPH-1 through TRIUMPH-CVOT — every Phase 3 result as it publishes, with a plain-English summary of what the numbers actually mean.
The day Eli Lilly officially files the New Drug Application with the FDA — the formal start of the FDA review clock.
The FDA's deadline to decide on Retatrutide. Once this date is set, you'll know the exact day to watch for the approval announcement.
Approval-day email within hours of the FDA decision — including who can prescribe it, what it costs, and where to fill the script.
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Every weight-loss number across our articles cites peer-reviewed sources — NEJM, JAMA, Diabetes Care.
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When will Retatrutide be available? The full tracker
Phase 3 status, every TRIUMPH trial readout, NDA timing, PDUFA estimates — the deeper version of the timeline above.
Nobody can promise an exact date. Eli Lilly's TRIUMPH-4 Phase 3 trial reported 28.7% mean weight loss in 2025 — the highest ever in a Phase 3 obesity trial. NDA submission to the FDA is expected in late 2026 or early 2027. Pharmaceutical analysts estimate a possible FDA approval window between late 2027 and 2028, contingent on the full Phase 3 results and FDA review timeline. We'll email you at every milestone so you don't have to keep refreshing news sites.
By email only. We'll email you within hours of every material milestone — Phase 3 readouts, NDA filing, FDA Advisory Committee, PDUFA date, and the moment Retatrutide hits pharmacies. Typically 4 to 8 emails per year, never weekly. Each email includes a one-line summary, the source link, and a plain-English explanation of what changed.
No. Retatrutide is not legally available outside Eli Lilly's clinical trials. Any product sold online today as "retatrutide" — research peptide, gray-market, "research only" — is from unregulated sources and represents a serious safety risk. Compounded retatrutide is also not a legal pathway: only semaglutide and tirzepatide are currently available compounded through licensed 503A pharmacies. If you want a GLP-1 today, see our 2026 telehealth comparison. Read our full disclosure for context.
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References
Not medical advice. This page is educational. Retatrutide is not FDA-approved as of 2026. Consult your physician before starting any GLP-1 medication. See our full FTC disclosure.