Eli Lilly and Company
Works in Cardiovascular · Dermatology · ENT · Genetic & rare · GI & liver · Hematology · Immunology · Infectious disease · Metabolic & endocrine · Musculoskeletal · Neurology · Oncology · Ophthalmology · Psychiatry · Renal & urogenital · Respiratory · Women's health
Eli Lilly and Company is a clinical trial sponsor. It has 222 active clinical trials with 199,426 planned participants, across 17 therapeutic areas. Since 2021 it has completed 484 trials and stopped 58 early. Its FDA record on file shows 3 warning letters.
Trial track record · since 2021
FDA record
Recent FDA actions
Financials
No SEC filings under this name. The company is private, listed abroad, or files under a parent.
Fundraising
No SEC Form D filings under this name. A private round is only public when the company files one.
Pipeline · 222 active trials
| Stage | Trial | Status |
|---|---|---|
On the market · 39 products
- KISUNLA donanemab-azbt · BLA 761248 · prescription
- ALIMTA pemetrexed disodium · NDA 021462 · prescription
- ZEPBOUND tirzepatide · NDA 217806 · prescription
- ZEPBOUND KWIKPEN tirzepatide · NDA 217806 · prescription
- ZEPBOUND (AUTOINJECTOR) tirzepatide · NDA 217806 · prescription
- OMVOH mirikizumab-mrkz · BLA 761279 · prescription
- HUMALOG KWIKPEN insulin lispro recombinant · BLA 205747 · prescription
- HUMULIN R PEN insulin recombinant human · BLA 018780 · over-the-counter
- HUMULIN R insulin recombinant human · BLA 018780 · over-the-counter
- HUMULIN R KWIKPEN insulin human · BLA 018780 · prescription
- AMYVID florbetapir f-18 · NDA 202008 · prescription
- HUMULIN N insulin susp isophane recombinant human · BLA 018781 · over-the-counter
- FOUNDAYO orforglipron calcium · NDA 220934 · prescription
- MOUNJARO tirzepatide · NDA 215866 · prescription
- MOUNJARO KWIKPEN tirzepatide · NDA 215866 · prescription
- MOUNJARO (AUTOINJECTOR) tirzepatide · NDA 215866 · prescription
- EMGALITY galcanezumab-gnlm · BLA 761063 · prescription
- FORTEO teriparatide · NDA 021318 · prescription
- HUMULIN 70/30 PEN insulin recombinant human, insulin susp isophane recombinant human · BLA 019717 · over-the-counter
- HUMULIN 70/30 insulin recombinant human, insulin susp isophane recombinant human · BLA 019717 · over-the-counter
- LYUMJEV insulin lispro-aabc · BLA 761109 · prescription
- EVISTA raloxifene hydrochloride · NDA 020815 · prescription
- CYRAMZA ramucirumab · BLA 125477 · prescription
- TRULICITY dulaglutide · BLA 125469 · prescription
- HUMALOG MIX 75/25 insulin lispro protamine recombinant, insulin lispro recombinant · BLA 021017 · prescription
- HUMALOG MIX 75/25 KWIKPEN insulin lispro protamine recombinant, insulin lispro recombinant · BLA 021017 · prescription
- HUMATROPE somatropin · BLA 019640 · prescription
- HUMALOG MIX 50/50 KWIKPEN insulin lispro protamine recombinant, insulin lispro recombinant · BLA 021018 · prescription
- HUMALOG MIX 50/50 insulin lispro protamine recombinant, insulin lispro recombinant · BLA 021018 · prescription
- OLUMIANT baricitinib · NDA 207924 · prescription
- HUMALOG KWIKPEN insulin lispro recombinant · BLA 020563 · prescription
- HUMALOG TEMPO PEN insulin lispro recombinant · BLA 020563 · prescription
- HUMALOG insulin lispro recombinant · BLA 020563 · prescription
- TALTZ ixekizumab · BLA 125521 · prescription
- CIALIS tadalafil · NDA 021368 · prescription
- TAUVID flortaucipir f-18 · NDA 212123 · prescription
- JAYPIRCA pirtobrutinib · NDA 216059 · prescription
- BASAGLAR insulin glargine · BLA 205692 · prescription
- REZVOGLAR insulin glargine-aglr · BLA 761215 · prescription
Questions about Eli Lilly and Company
Yes. FDA has published 3 warning letters naming Eli Lilly and Company; the latest was posted on 2025-09-16. Each letter links to FDA's own posting.
Eli Lilly and Company is lead sponsor of 222 active clinical trials on ClinicalTrials.gov, with 199,426 planned participants, in Cardiovascular, Dermatology, ENT, Genetic & rare and other areas. Since 2021 it has completed 484 trials and stopped 58 early.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Eli Lilly and Company; every record links to the source, and nothing here is advice.
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Trial counts are as the sponsor reported them to ClinicalTrials.gov, for trials changed since 2021; latest update 2026-10-16.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
Products come from FDA's drug application database and, for vaccines, cell and gene therapies and blood products, FDA's Purple Book of licensed biologics; checked 2026-10-02.
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