LLY · Company research

Eli Lilly and Company

2 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

FDA decisionLLYEli Lilly and CompanyH2 2026

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.

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FDA decision on tirzepatide MACE-reduction indication (SURPASS-CVOT) · FDA decision due (PDUFA date)

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

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.

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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

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MilestoneLLYEli Lilly and CompanyQ1 2027

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.

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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.

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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

Past catalysts

Trial resultsLLYEli Lilly and CompanyJul 23, 2026

Eli Lilly and Company reported results from its Phase 3 study of retatrutide for Obesity with type 2 diabetes; obesity with established CVD on Jul 23, 2026. The study met its main goal.

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Phase 3 TRIUMPH-2 and TRIUMPH-3 met primary endpoints for retatrutide · Clinical trial results (readout / topline data)

Drug

retatrutide

For

Obesity with type 2 diabetes; obesity with established CVD

Stage

Phase 3 · the last stage before a drug can be approved

When

Jul 23, 2026

Source note

TRIUMPH-2 delivered 12.7%-20.8% weight loss with A1C cuts up to 1.6% in type 2 diabetes; TRIUMPH-3 delivered up to 22.6% weight loss in severe obesity with established cardiovascular disease. BLA submission planned for Q1 2027.

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Source: prnewswire.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

ConferenceLLYEli Lilly and CompanyJun 14, 2026

Eli Lilly and Company presented data on Jaypirca (pirtobrutinib) + venetoclax + rituximab for Relapsed/refractory CLL/SLL at a medical meeting on Jun 14, 2026. The linked source has the details.

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Entry

EHA 2026: Phase 3 BRUIN CLL-322 cut progression or death risk 45% with Jaypirca · Data presented at a medical meeting

Drug

Jaypirca (pirtobrutinib) + venetoclax + rituximab

For

Relapsed/refractory CLL/SLL

Stage

Phase 3 · the last stage before a drug can be approved

When

Jun 14, 2026

Source note

Adding pirtobrutinib to venetoclax plus rituximab reduced risk of progression or death by 45% (HR 0.55; p=0.0001) in 639 previously treated CLL/SLL patients; median PFS was not reached versus 39.7 months. Late-breaking oral at EHA 2026.

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Source: biospace.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

ConferenceLLYEli Lilly and CompanyJun 8, 2026

Eli Lilly and Company presented data on Foundayo (orforglipron) for Type 2 diabetes at a medical meeting on Jun 8, 2026. The linked source has the details.

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Entry

ADA 2026: Foundayo beat oral semaglutide on A1C in Phase 3 ACHIEVE-3 · Data presented at a medical meeting

Drug

Foundayo (orforglipron)

For

Type 2 diabetes

Stage

Phase 3 · the last stage before a drug can be approved

When

Jun 8, 2026

Source note

Detailed results from ACHIEVE-2, ACHIEVE-3 and ACHIEVE-5 showed Foundayo superior to oral semaglutide on A1C (57.1% greater relative reduction at top doses) and weight, and superior to dapagliflozin and to placebo added to insulin glargine.

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Source: biospace.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

ConferenceLLYEli Lilly and CompanyJun 6, 2026

Eli Lilly and Company presented data on retatrutide for Obesity and obesity-related complications at a medical meeting on Jun 6, 2026. The linked source has the details.

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Entry

ADA 2026: retatrutide improved weight, A1C, knee OA pain and sleep apnea · Data presented at a medical meeting

Drug

retatrutide

For

Obesity and obesity-related complications

Stage

Phase 3 · the last stage before a drug can be approved

When

Jun 6, 2026

Source note

Lilly presented additional Phase 3 results from TRIUMPH-1 and TRANSCEND-T2D-1 at the ADA 86th Scientific Sessions showing substantial weight loss plus improvements in knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea and type 2 diabetes.

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Source: prnewswire.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

Trial resultsLLYEli Lilly and CompanyMay 21, 2026

Eli Lilly and Company reported results from its Phase 3 study of retatrutide for Obesity / overweight with comorbidity on May 21, 2026. The study met its main goal.

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Entry

Phase 3 TRIUMPH-1: retatrutide delivered up to 28.3% weight loss at 80 weeks · Clinical trial results (readout / topline data)

Drug

retatrutide

For

Obesity / overweight with comorbidity

Stage

Phase 3 · the last stage before a drug can be approved

When

May 21, 2026

Source note

In 2,339 adults with obesity or overweight without diabetes, the 12 mg dose produced an average 70.3 lbs (28.3%) weight loss at 80 weeks, rising to 30.3% among those continuing to 104 weeks.

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Source: prnewswire.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

ApprovalLLYEli Lilly and CompanyApr 1, 2026

The FDA approved Eli Lilly and Company’s Foundayo (orforglipron) for Obesity / overweight with weight-related comorbidity on Apr 1, 2026. The company can now sell it in that market.

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Entry

FDA approves Foundayo (orforglipron), first oral GLP-1 pill for obesity · Regulatory approval

Drug

Foundayo (orforglipron)

For

Obesity / overweight with weight-related comorbidity

Stage

Regulatory (NDA)

When

Apr 1, 2026

Source note

FDA approved the once-daily oral GLP-1 for adults with obesity or overweight with weight-related conditions, with no food or water restrictions. ATTAIN-1 showed 12.4% average weight loss at the top dose over 72 weeks.

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Source: prnewswire.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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsLLYEli Lilly and CompanyApr 28, 2022

Eli Lilly and Company reported results from its Phase 3 study of tirzepatide (Zepbound) for Obesity on Apr 28, 2022. The linked source has what the numbers showed.

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Entry

SURMOUNT-1 topline: tirzepatide up to 22.5% weight loss · Clinical trial results (readout / topline data)

Drug

tirzepatide (Zepbound)

For

Obesity

Stage

Phase 3 · the last stage before a drug can be approved

When

Apr 28, 2022

Source note

Phase 3 obesity readout that reset expectations for the incretin class.

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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

Things of Interest

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

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