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Research → decisions → accessEvidence checked 13 Sep 2026

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A clearer view of the milestones shaping peptide and GLP-1 medicines in the UK, US and EU: confirmed decisions, company targets and clearly labelled estimates, each with its source. What we track · How estimates are made.

Retatrutide

Eli Lilly · GIP, GLP-1 and glucagon receptor agonist · Peptide · Investigational
RangeNext four yearsAll milestonesZoomQuartersYears
Region
20262027202820292030
USFDA
TodayQ1 2027 · filing plannedJan 2028 to Jun 2028
Estimate
UKMHRA
Timing unknown ›
EUEMA / European Commission
Timing unknown ›
US · Q1 2027 · filing plannedCompany target · Q1 2027US · Jan 2028 to Jun 2028GLPInfo estimate · low timing confidence · conditional scenarioUK · Timing unknownTiming unknownEU · Timing unknownTiming unknown
Confirmed eventCompany targetRegulator targetEditorial estimateTiming unknown or undatedSafety update

Dashed line: today, 13 Sep 2026. Future windows are conditional. Approval, launch and funded access are separate milestones.

Company target · Q1 2027United States

Lilly plans a US submission for retatrutide in Q1 2027

Announcing two further Phase 3 results on 23 July 2026, Lilly said it planned to submit retatrutide to the FDA in the first quarter of 2027 while completing manufacturing-related documentation.

Why it matters. This is sponsor guidance, not an application acceptance or an approval date. Any approval timing is an estimate conditional on the filing happening.

Event
Submission planned
Indication
Chronic weight management (Obesity, or overweight with at least one weight-related condition, alongside diet and physical activity)
Product
Retatrutide, once-weekly injection
Authority
FDA
Event date
Q1 2027
Published
13 Sep 2026
Last checked
13 Sep 2026
Record version
v1
Eli Lilly, 23 Jul 2026 ↗ Report a correction Follow Retatrutide Company target
Select a milestone to see its evidence. Keyboard: Tab to a marker, arrow keys to move, Enter to open.Estimates describe timing only, never a probability of approval.

All Retatrutide records (accessible list)

Retatrutide

Investigational once-weekly triple agonist in Phase 3 for obesity and related conditions.

United Kingdom

No responsible range yet · Approval Timing unknown

Chronic weight management

No UK filing plan has been verified. An illustrative 2028 to 2029 scenario would depend on a 2027 or 2028 filing and a positive national or eligible international-recognition decision; it stays out of the headline until a filing anchor exists.

Next observable milestone: Sponsor statement on UK filing

Source: MHRA

Reviewed by GLPInfo editorial · next review 13 Oct 2026 · version 1

United States

Q1 2027 · Submission planned Company target

Lilly plans a US submission for retatrutide in Q1 2027

Chronic weight management

Announcing two further Phase 3 results on 23 July 2026, Lilly said it planned to submit retatrutide to the FDA in the first quarter of 2027 while completing manufacturing-related documentation.

Why it matters: This is sponsor guidance, not an application acceptance or an approval date. Any approval timing is an estimate conditional on the filing happening.

Source: Eli Lilly, 23 Jul 2026

Last checked 13 Sep 2026 · Report a correction

January 2028 to June 2028 · Approval (conditional scenario) GLPInfo estimate

Chronic weight management

Conditional on submission in Q1 2027, filing acceptance, a standard original-application review and a positive first-cycle decision. A Q1 filing plus roughly 12 months of review centres on Q1 2028; H1 2028 allows limited slippage. Priority review, if actually granted, could allow a 2027 decision. Delays or a negative decision remain possible.

Confidence in timing: low. No filing has been made; the timing rests entirely on sponsor guidance and standard review goals. This describes confidence in the timing only, not a probability of approval.

Next observable milestone: FDA submission (sponsor target Q1 2027)

Sources: Eli Lilly, 23 Jul 2026; US Food and Drug Administration, September 2021

Reviewed by GLPInfo editorial · next review 13 Oct 2026 · version 1

European Union

No responsible range yet · Approval Timing unknown

Chronic weight management

No EU application timing has been verified. An illustrative 2028 to 2029 scenario would depend on a 2027 submission and an assessment with ordinary clock stops; it stays out of the headline until a filing anchor exists.

Next observable milestone: Sponsor statement on EU filing

Source: European Medicines Agency

Reviewed by GLPInfo editorial · next review 13 Oct 2026 · version 1

This list is the complete, accessible view of the tracker; the board above draws from exactly the same records. Every entry is labelled Confirmed (official record), Company target (a dated sponsor statement), Regulator target (an official decision date, not a guarantee), GLPInfo estimate (an editorial range with assumptions) or Timing unknown. An approval is never inferred from a target date passing.