Medicine profile
Retatrutide
Investigational once-weekly triple agonist in Phase 3 for obesity and related conditions.
- Generic name
- Retatrutide
- Also known as
- LY3437943, triple agonist
- Sponsor and licensing
- Eli Lilly (originator)
- Mechanism
- GIP, GLP-1 and glucagon receptor agonist
- Molecular type
- Peptide (mechanism and molecular type are recorded separately: GLP-1 activity does not make a medicine a peptide)
Brands, routes and formulations
Retatrutide (no brand yet)
subcutaneous · once-weekly injection
No verified approval recorded for this product.
Regulatory status by jurisdiction
Authorisation, launch and funded access are three different things and are shown separately. "Not recorded" means GLPInfo has not verified an event, not that nothing has happened.
| United States (FDA) | United Kingdom (MHRA) | European Union (EMA / EC) | |
|---|---|---|---|
| Regulatory authorisation | Not recorded | Not recorded | Not recorded |
| Commercial launch | Not recorded | Not recorded | Not recorded |
| Funded access | Not recorded | Not recorded | Not recorded |
Development timeline
Retatrutide
Dashed line: today, 13 Sep 2026. Future windows are conditional. Approval, launch and funded access are separate milestones.
Select a marker to open its record in the pipeline view, which has the detail panel and the accessible list.
Next milestone and forecast rationale
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
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
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
Trial evidence
| Trial | Phase | Population | Duration | Results |
|---|---|---|---|---|
| TRIUMPH-1Eli Lilly · subcutaneous, once weekly | 3 | 2,335 adults without type 2 diabetes; BMI 30 or more, or 27 or more with at least one weight-related condition | 80 weeks | On file from the research workbook; withheld until the primary publication or registry record is attached. |
GLPInfo does not rank unrelated trials against each other or quote "weight loss per week": populations, durations and methods differ and weight change is not linear. Results appear here per trial and dose arm, with comparator, endpoint and source, once cited.
Known limitations and official labels
This profile is assembled from the regulatory records and sponsor statements GLPInfo has verified; it is not a complete review of Retatrutide. The current official label in each jurisdiction is the authority on indications, populations and safety.
Review date and correction history
Records last checked 13 Sep 2026. No corrections have been made to the records on this profile; every record is at version 1. Report a correction.
Related news
Retatrutide: Lilly plans a US submission in Q1 2027. What that does and does not tell you
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. GLPInfo shows this as a company target and keeps its conditional approval scenario in the detail view only.