Eli Lilly R&D profile, November 2026: pipeline, trials and peer comparison

We asked:

Define Lilly trials as studies in aact whose lead sponsor (sponsors.lead_or_collaborator = ‘lead’) has one of exactly these names: ‘Eli Lilly and Company’, ‘Avid Radiopharmaceuticals’, ‘Loxo Oncology, Inc.’, ‘Dermira, Inc.’, ‘DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘Adverum Biotechnologies, Inc.’, ‘Prevail Therapeutics’, ‘Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)’, ‘Verve Therapeutics, Inc.’, ‘Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company’, ‘POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company’, ‘Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company’, ‘Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘SiteOne Therapeutics, Inc.’, ‘Sigilon Therapeutics, Inc.’. Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). How many Lilly trials are there in all? How many are active? Break the active ones down by phase (Early Phase 1 and Phase 1 together, Phase 1/2, Phase 2, Phase 2/3, Phase 3, and no phase). Then give Lilly trial starts by year for 2016 to 2026, saying how many of the 2026 starts have an ESTIMATED rather than ACTUAL start date.

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Of the 92 trials with a 2026 start date, 18 are marked ESTIMATED and 74 ACTUAL

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Using the same Lilly trials, count trials started in 2011-2015, 2016-2020 and 2021 onward in each of these areas, taken from the trial’s own MeSH condition terms (browse_conditions with mesh_type = ‘mesh-list’) joined to mesh_terms on downcase_mesh_term and the first three characters of tree_number: C04 neoplasms, C18 nutritional and metabolic diseases, C19 endocrine diseases, C10 nervous system diseases, F03 mental disorders, C20 immune system diseases, C14 cardiovascular diseases. A trial counts once in each area it touches, so areas overlap. Also give the number of Lilly trials started in each period, and how many of those have no term in any of these areas.

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No-area share is high and driven by missing MeSH data, not by genuinely unrelated trials: of the 583 trials with no area term, 431 have no mesh-list condition term at all

We asked:

Define Lilly trials as studies in aact whose lead sponsor (sponsors.lead_or_collaborator = ‘lead’) has one of exactly these names: ‘Eli Lilly and Company’, ‘Avid Radiopharmaceuticals’, ‘Loxo Oncology, Inc.’, ‘Dermira, Inc.’, ‘DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘Adverum Biotechnologies, Inc.’, ‘Prevail Therapeutics’, ‘Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)’, ‘Verve Therapeutics, Inc.’, ‘Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company’, ‘POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company’, ‘Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company’, ‘Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘SiteOne Therapeutics, Inc.’, ‘Sigilon Therapeutics, Inc.’. Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). In active Lilly trials, take interventions of type DRUG, BIOLOGICAL, GENETIC or COMBINATION_PRODUCT in design groups of type EXPERIMENTAL. Link them to moieties in fda.study_ingredients, following the fda guide’s method for which arm gets a drug. Keep moieties with first_approval_date NULL in fda.ingredients. Give one row per moiety whose highest active phase is Phase 2 or Phase 3: name, highest active phase, number of distinct active trials and the main conditions. Give the number of moieties by highest active phase, including Phase 1 and Phase 1/2. Say which rows are salt forms of the same drug or false positives.

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After merging the salt/duplicate pairs below, the distinct investigational drugs are 11 in Phase 3 and 9 in Phase 2

ClinLit AI also named its false positives, such as abiraterone, which is approved as abiraterone acetate:

abiraterone (G819A456D0) is approved as abiraterone acetate (EM5OCB9YJ6, first approval 2011-04-28)

Those 11 and ixo-vec, a gene therapy that the drug dictionary link doesn’t reach, make the 12 in the table.

We asked:

Define Lilly trials as studies in aact whose lead sponsor (sponsors.lead_or_collaborator = ‘lead’) has one of exactly these names: ‘Eli Lilly and Company’, ‘Avid Radiopharmaceuticals’, ‘Loxo Oncology, Inc.’, ‘Dermira, Inc.’, ‘DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘Adverum Biotechnologies, Inc.’, ‘Prevail Therapeutics’, ‘Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)’, ‘Verve Therapeutics, Inc.’, ‘Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company’, ‘POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company’, ‘Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company’, ‘Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘SiteOne Therapeutics, Inc.’, ‘Sigilon Therapeutics, Inc.’. Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). In active Lilly trials, take intervention names in design groups of type EXPERIMENTAL that match LY followed by digits, and that have no row in fda.study_ingredients for that trial and intervention name. Normalise each by removing spaces, hyphens and suffixes such as IV or SC. Check each normalised code against fda.substance_names using fda.normalize_name, and split them into codes that resolve to a known moiety (say which) and codes that resolve to nothing. For codes that resolve to nothing, give the number of distinct codes by highest active phase and list those in Phase 2 or Phase 3 with their conditions.

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The 56 “unresolved” codes are unresolved as codes: several are clearly known drugs whose FDA entry uses a different name

We asked:

Define Lilly trials as studies in aact whose lead sponsor (sponsors.lead_or_collaborator = ‘lead’) has one of exactly these names: ‘Eli Lilly and Company’, ‘Avid Radiopharmaceuticals’, ‘Loxo Oncology, Inc.’, ‘Dermira, Inc.’, ‘DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘Adverum Biotechnologies, Inc.’, ‘Prevail Therapeutics’, ‘Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)’, ‘Verve Therapeutics, Inc.’, ‘Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company’, ‘POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company’, ‘Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company’, ‘Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘SiteOne Therapeutics, Inc.’, ‘Sigilon Therapeutics, Inc.’. Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). In active Lilly trials, take drugs in design groups of type EXPERIMENTAL that fda.study_ingredients links to a moiety that has an FDA application with sponsor in (‘LILLY’,‘ELI LILLY AND CO’,‘ELI LILLY CO’,‘LILLY RES LABS’,‘AVID RADIOPHARMS INC’,‘LOXO ONCOL’) through fda.application_ingredients. Give one row per moiety: name, first approval date, highest active phase, number of active trials and the main conditions, sorted by number of active trials.

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We asked:

Define Lilly trials as studies in aact whose lead sponsor (sponsors.lead_or_collaborator = ‘lead’) has one of exactly these names: ‘Eli Lilly and Company’, ‘Avid Radiopharmaceuticals’, ‘Loxo Oncology, Inc.’, ‘Dermira, Inc.’, ‘DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘Adverum Biotechnologies, Inc.’, ‘Prevail Therapeutics’, ‘Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)’, ‘Verve Therapeutics, Inc.’, ‘Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company’, ‘POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company’, ‘Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company’, ‘Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘SiteOne Therapeutics, Inc.’, ‘Sigilon Therapeutics, Inc.’. Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). List active Phase 3 Lilly trials whose primary_completion_date falls between 2026-11-08 and 2027-11-08: NCT ID, drug, condition, enrollment, primary completion date and whether that date is ESTIMATED or ACTUAL. Give the total, then the count by drug. Cap the list at 40 rows, largest enrollment first.

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The incretin portfolio dominates: 15 of the 19 trials are GLP-1/GIP agents

We asked:

What phase 3 topline results has Lilly announced for retatrutide up to November 2026? Check PubMed first for anything published, then Lilly’s press releases on the web. Give the date and source of each, and say which are company announcements that are not peer reviewed.

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so match the estimand before comparing numbers

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What was the FDA approval of orforglipron (Foundayo), when was it, and for what indication? Check our FDA data, then give the FDA or Lilly source on the web. Then list any peer-reviewed phase 3 publications of orforglipron in PubMed with PMIDs.

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We asked:

Define Lilly trials as studies in aact whose lead sponsor (sponsors.lead_or_collaborator = ‘lead’) has one of exactly these names: ‘Eli Lilly and Company’, ‘Avid Radiopharmaceuticals’, ‘Loxo Oncology, Inc.’, ‘Dermira, Inc.’, ‘DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘Adverum Biotechnologies, Inc.’, ‘Prevail Therapeutics’, ‘Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)’, ‘Verve Therapeutics, Inc.’, ‘Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company’, ‘POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company’, ‘Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company’, ‘Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘SiteOne Therapeutics, Inc.’, ‘Sigilon Therapeutics, Inc.’. Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). Using aact_history.study_changes (it starts in August 2024), answer three things for Lilly trials. 1) How many changed overall_status to TERMINATED, WITHDRAWN or SUSPENDED since then, by phase, and for the Phase 2 and Phase 3 ones list NCT ID, drug, condition and the why_stopped text, at most 25 rows. 2) For Phase 3 Lilly trials, how many changes to primary_completion_date moved it later and how many earlier, and what was the median shift in days each way? Note any reason an earlier move may not be a real acceleration. 3) Which trials changed lead_sponsor into or out of the Lilly names, excluding changes that are only a rename of the same organisation?

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So the later-moves (median +78 days) are the more interpretable signal; part of the earlier-move count reflects stopping, correction and estimate-to-actual substitution rather than acceleration.

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Lilly’s FDA applications are fda.applications with sponsor in (‘LILLY’,‘ELI LILLY AND CO’,‘ELI LILLY CO’,‘LILLY RES LABS’,‘AVID RADIOPHARMS INC’,‘IMCLONE’,‘LOXO ONCOL’). Using is_novel as the proxy for novel approvals, list Lilly’s novel approvals with first_approval_date since 2016-01-01: application, brand, ingredient, approval date, application type and orig_review_priority, and give the count by year. Then, for Lilly’s currently marketed NDAs, give the latest patent expiry and latest exclusivity expiry per application from fda.patents and fda.exclusivities, sorted by latest patent expiry. Then say how many currently marketed Lilly BLAs there are and whether fda.patents covers them.

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That is a coverage gap, not evidence that these biologics have no IP

We asked:

Define each company’s trials by lead sponsor (sponsors.lead_or_collaborator = ‘lead’, agency_class = ‘INDUSTRY’) and name as follows. Lilly: name in (‘Eli Lilly and Company’,‘Avid Radiopharmaceuticals’,‘Loxo Oncology, Inc.’,‘Dermira, Inc.’,‘Adverum Biotechnologies, Inc.’,‘Prevail Therapeutics’,‘Verve Therapeutics, Inc.’,‘SiteOne Therapeutics, Inc.’,‘Sigilon Therapeutics, Inc.’) or name ~* ‘wholly owned subsidiary of Eli Lilly’. Novo Nordisk: name ~* ‘Novo Nordisk’. AstraZeneca: name ~* ‘^(AstraZeneca|MedImmune|Alexion Pharmaceuticals|Acerta Pharma)’. Pfizer: name = ‘Pfizer’ or name = ‘Seagen Inc.’ or name ~* ‘wholly owned subsidiary of Pfizer’ (this leaves out ‘Pfizer’‘s Upjohn has merged with Mylan to form Viatris Inc.’). Merck & Co.: name ~* ‘^Merck Sharp’ or name ~* ‘subsidiary of Merck (Sharp|& Co)’ (this leaves out Merck KGaA). Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). Make one table with a row per company: all lead-sponsored trials; active trials; active Phase 3 (phase = ‘PHASE3’); active Phase 3 with primary_completion_date between 2026-11-08 and 2027-11-08; trials started since 2016-01-01; of those, the percent with overall_status TERMINATED or WITHDRAWN; for Phase 3 trials started since 2016, median enrollment and median number_of_facilities from calculated_values. Note what each definition may miss.

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The termination rate only sees current registry status

We asked:

In fda.applications, match the sponsor column as follows. Lilly: sponsor ~* ‘lilly|^avid radio|^imclone|^loxo’. Novo Nordisk: sponsor ~* ‘^novo( |$)’. AstraZeneca: sponsor ~* ‘astrazeneca|medimmune|alexion’. Pfizer: sponsor ~* ‘pfizer|wyeth|seagen’. Merck & Co.: sponsor ~* ‘^(merck|msd)’ and sponsor !~* ‘kgaa’. Using is_novel as the proxy for novel approvals, give one table with a row per company: novel approvals with first_approval_date since 2016-01-01, of which BLAs, of which in 2021 or later; currently marketed NDAs that have patents in fda.patents; of those, how many have their latest-expiring patent between 2026-11-08 and 2029-11-08; and currently marketed BLAs. Note that the sponsor column is the current holder and what that does to these counts.

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Acquired portfolios are pulled into the acquirer’s row.

We asked:

Define each company’s trials by lead sponsor (sponsors.lead_or_collaborator = ‘lead’, agency_class = ‘INDUSTRY’) and name as follows. Lilly: name in (‘Eli Lilly and Company’,‘Avid Radiopharmaceuticals’,‘Loxo Oncology, Inc.’,‘Dermira, Inc.’,‘Adverum Biotechnologies, Inc.’,‘Prevail Therapeutics’,‘Verve Therapeutics, Inc.’,‘SiteOne Therapeutics, Inc.’,‘Sigilon Therapeutics, Inc.’) or name ~* ‘wholly owned subsidiary of Eli Lilly’. Novo Nordisk: name ~* ‘Novo Nordisk’. AstraZeneca: name ~* ‘^(AstraZeneca|MedImmune|Alexion Pharmaceuticals|Acerta Pharma)’. Pfizer: name = ‘Pfizer’ or name = ‘Seagen Inc.’ or name ~* ‘wholly owned subsidiary of Pfizer’ (this leaves out ‘Pfizer’‘s Upjohn has merged with Mylan to form Viatris Inc.’). Merck & Co.: name ~* ‘^Merck Sharp’ or name ~* ‘subsidiary of Merck (Sharp|& Co)’ (this leaves out Merck KGaA). Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). For trials started in 2016-2020 and from 2021 onward, make a table with a row per company and period: number of Phase 3 trials; percent with at least one site in China; percent with at least one site in the United States (aact.countries, excluding rows with removed = true). Then for trials started since 2021-01-01, give each company’s count of trials in these areas from the trial’s own MeSH condition terms (browse_conditions with mesh_type = ‘mesh-list’ joined to mesh_terms on downcase_mesh_term, first three characters of tree_number): C04 neoplasms, C18 nutritional and metabolic, C19 endocrine, C10 nervous system, C20 immune system, C14 cardiovascular. A trial counts once in each area it touches.

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ClinLit AI labelled the last column of its area table “All trials started 2021+”. Those numbers are the trials in at least one of the six areas (284 for Lilly, of 506 started), so we left that column out.

We asked:

Define Lilly trials as studies in aact whose lead sponsor (sponsors.lead_or_collaborator = ‘lead’) has one of exactly these names: ‘Eli Lilly and Company’, ‘Avid Radiopharmaceuticals’, ‘Loxo Oncology, Inc.’, ‘Dermira, Inc.’, ‘DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘Adverum Biotechnologies, Inc.’, ‘Prevail Therapeutics’, ‘Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)’, ‘Verve Therapeutics, Inc.’, ‘Vaccine Company, Inc, a wholly owned subsidiary of Eli Lilly and Company’, ‘POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company’, ‘Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company’, ‘Ajax Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company’, ‘SiteOne Therapeutics, Inc.’, ‘Sigilon Therapeutics, Inc.’. Active means overall_status in (‘RECRUITING’,‘NOT_YET_RECRUITING’,‘ACTIVE_NOT_RECRUITING’,‘ENROLLING_BY_INVITATION’). How many Lilly trials have at least one linked PubMed article, counting links from pubmed.article_databank_accessions (accession_number = nct_id) and aact.study_references (PMIDs that exist in pubmed.articles)? Give the total, as a share of all Lilly trials, and for Phase 3 Lilly trials with a primary completion date between 2016 and 2024 only. Then count PubMed articles per year for 2019 to 2026, tagged in pubmed.chemicals with each of tirzepatide, orforglipron, retatrutide, donanemab, mirikizumab and imlunestrant, checking the names against pubmed.substances first. Say what these counts can miss, including for the current year.

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so this measures “has a linked paper”, not “has a results paper”.

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In TRAILBLAZER-ALZ 2, the phase 3 trial of donanemab in early Alzheimer’s disease (NCT04437511), how did the primary endpoint, the study population and the sample size change between protocol amendments, and what reasons does the protocol give? Cite the protocol pages.

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When we opened the cited pages, two page numbers were one too low: the amendment c and d passages are on PDF pages 113 and 107, not 112 and 106. The pages above are the corrected ones.

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Which documents has the phase 3 orforglipron obesity trial ATTAIN-1 (NCT05869903) posted? If a protocol is posted, what are its primary endpoints and estimands, and how did it choose its sample size? Cite the protocol pages.

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ClinLit AI gave the significance level as 0.017. The protocol’s page 120 says 0.016, so we used that.

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For tirzepatide, donanemab, baricitinib, mirikizumab, lebrikizumab, selpercatinib and pirtobrutinib, make a table of: whether the US label has a boxed warning and what it warns of; serious FAERS reports in total (all reports in our FAERS data are serious reports received in the last 10 years); deaths reported; and the three reaction terms with the strongest disproportionality that have at least 50 reports, with PRR and lower confidence limit. Use the words reported and signal for review, never risk, rate or cause, and state what FAERS cannot show.

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Disproportionality (PRR, ROR) is only a signal for review