FDA decision on tirzepatide MACE-reduction indication (SURPASS-CVOT)
The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve Eli Lilly and Company’s Tirzepatide (Mounjaro) for Reduction of major adverse cardiovascular events in type 2 diabetes. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Eli Lilly and Company LLY
- Drug
- Tirzepatide (Mounjaro)
- For
- Reduction of major adverse cardiovascular events in type 2 diabetes
- Stage
- sNDA under review
- When
- H2 2026 · the company gave a window, not a day; the calendar never invents one
- Source note
- Prime Therapeutics' GLP-1 pipeline tracker (May 2026) says an FDA decision on the SURPASS-CVOT-based CV indication is expected mid-2026; pdufa.bio estimates Q4 2026. No exact PDUFA date has been disclosed by Lilly, and the decision may land at any point in H2 2026 — verify current status before publishing.
- Checked
- Checked by a person when it was added
- Source: primetherapeutics.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- LLY headlines on this site
Retatrutide US regulatory submission for obesity planned Q1 2027, expected in Q1 2027 (Jan–Mar) (no exact date yet). A company milestone for Eli Lilly and Company (Retatrutide (GIP/GLP-1/glucagon triple agonist) for Obesity / chronic weight management): a step in the program rather than a decision or a data readout.
More details
- Entry
- Retatrutide US regulatory submission for obesity planned Q1 2027 · Company milestone
- Drug
- Retatrutide (GIP/GLP-1/glucagon triple agonist)
- For
- Obesity / chronic weight management
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q1 2027 · the company gave a window, not a day
- Source note
- After positive Phase 3 TRIUMPH-1/-2/-3 topline results (up to ~30% average weight loss), Lilly said it is completing the CMC package and plans to submit retatrutide for US approval in Q1 2027 (reported by CNBC from company statements, July 23, 2026). An FDA decision would follow in 2027 or later depending on review designation.
- Checked
- Checked by a person when it was added
- Verify it
- Source: cnbc.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- LLY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page