Developer · LLY · United States

Eli Lilly and Company

Global pharmaceutical company headquartered in Indianapolis, Indiana (NYSE: LLY), with one of the deepest Alzheimer's disease pipelines in the industry. Solanezumab was its first anti-amyloid antibody to reach Phase 3; after its failure across four disease stages Lilly pivoted to the plaque-clearing antibodies donanemab (KISUNLA, approved 2024) and remternetug.

lilly.com ↗

2compounds
2programs
2indications
Discontinuedlead asset

Phase distribution

  • Discontinued2

Modality

  • Biologic 1
  • Small molecule 1

Mechanism focus

Pipeline (2)

Deals & partnerships

  • Feb 11, 2026PartnershipDenovo Biopharma partners with Orygen on an investigator-initiated Phase 2 study of DB103 (pomaglumetad methionil) in early psychosisDenovo announced a partnership with Orygen (Parkville, Australia; lead investigator Prof. Patrick McGorry) to conduct an open-label Phase 2 investigator-initiated feasibility trial of pomaglumetad methionil 40 mg twice daily for 12 weeks in young people aged 18-25 with first-episode psychosis insufficiently responsive to a first-line antipsychotic, or with clinical-high-risk symptoms that failed to remit. Ethics approval: Royal Melbourne Hospital HREC Project 2024.289. As of 2026-08-12 the study has no ClinicalTrials.gov or findable ANZCTR registration, so it is recorded as an announcement, not a trial.Pomaglumetad methionilsource ↗
  • Mar 3, 2015Licensing dealDenovo Biopharma licenses exclusive global rights to pomaglumetad methionil from Eli LillyDenovo Biopharma obtained exclusive global rights to develop, manufacture and commercialize pomaglumetad methionil (LY2140023, becoming DB103), including transfer of all intellectual property, data and information from Lilly's ~37-trial, >3,800-subject program. Lilly retained an option to re-acquire the compound upon a successful clinical trial at predetermined, undisclosed terms. Denovo's stated plan: retrospective genomic biomarker discovery on archived trial samples to identify a responsive subpopulation.Pomaglumetad methionilsource ↗

Catalysts · 0 upcoming · 8 reported

Recently reported

  • 2023-09-21missed

    SolanezumabforAlzheimer's diseaseFull results

    Full A4 results published: no effect of solanezumab on cognitive decline or amyloid accumulation in preclinical Alzheimer's disease (Sperling et al., NEJM 2023).

    source ↗

  • 2023-03-08missed

    SolanezumabforAlzheimer's diseaseTopline data

    A4 study: solanezumab does not slow cognitive decline in preclinical (asymptomatic, amyloid-positive) Alzheimer's disease and does not clear brain amyloid plaque; Lilly ends solanezumab development for AD.

    source ↗

  • 2020-02-10missed

    SolanezumabforAlzheimer's diseaseTopline data

    Solanezumab arm of the DIAN-TU platform trial misses its cognitive primary endpoint in dominantly inherited Alzheimer's disease; Lilly will not pursue a submission in this population.

    source ↗

  • 2018-01-25missed

    SolanezumabforAlzheimer's diseaseFull results

    Full EXPEDITION3 results published: solanezumab 400 mg q4w did not significantly affect cognitive decline in mild Alzheimer's dementia (Honig et al., NEJM 2018;378:321-330).

    source ↗

  • 2016-11-23missed

    SolanezumabforAlzheimer's diseaseTopline data

    EXPEDITION3 misses its primary endpoint in mild Alzheimer's dementia (ADAS-Cog14, p=0.095); Lilly will not pursue regulatory submission for solanezumab in mild AD dementia.

    source ↗

  • 2014-01-23missed

    SolanezumabforAlzheimer's diseaseFull results

    Full EXPEDITION/EXPEDITION2 Phase 3 results published: solanezumab failed to improve cognition or functional ability in mild-to-moderate Alzheimer's disease (Doody et al., NEJM 2014;370:311-321).

    source ↗

  • 2012-08-29missed

    Pomaglumetad methionilforSchizophreniaInterim analysis

    Independent futility analysis of HBBN concluded the second pivotal study was unlikely to succeed; Lilly stopped all Phase 3 development of pomaglumetad methionil the same day.

    source ↗

  • 2012-08-24missed

    SolanezumabforAlzheimer's diseaseTopline data

    EXPEDITION and EXPEDITION2 both miss their co-primary cognitive and functional endpoints in mild-to-moderate Alzheimer's disease; pre-specified pooled secondary analyses suggest slowing of cognitive decline in mild AD only.

    source ↗

Recent activity

  • Sep 21, 2023ReadoutSolanezumab·Alzheimer's diseasemissedFull A4 results published: no effect of solanezumab on cognitive decline or amyloid accumulation in preclinical Alzheimer's disease (Sperling et al., NEJM 2023).source ↗
  • Mar 8, 2023ReadoutSolanezumab·Alzheimer's diseasemissedA4 study: solanezumab does not slow cognitive decline in preclinical (asymptomatic, amyloid-positive) Alzheimer's disease and does not clear brain amyloid plaque; Lilly ends solanezumab development for AD.source ↗
  • Feb 10, 2020ReadoutSolanezumab·Alzheimer's diseasemissedSolanezumab arm of the DIAN-TU platform trial misses its cognitive primary endpoint in dominantly inherited Alzheimer's disease; Lilly will not pursue a submission in this population.source ↗
  • Jan 25, 2018ReadoutSolanezumab·Alzheimer's diseasemissedFull EXPEDITION3 results published: solanezumab 400 mg q4w did not significantly affect cognitive decline in mild Alzheimer's dementia (Honig et al., NEJM 2018;378:321-330).source ↗
  • Nov 23, 2016ReadoutSolanezumab·Alzheimer's diseasemissedEXPEDITION3 misses its primary endpoint in mild Alzheimer's dementia (ADAS-Cog14, p=0.095); Lilly will not pursue regulatory submission for solanezumab in mild AD dementia.source ↗
  • Jan 23, 2014ReadoutSolanezumab·Alzheimer's diseasemissedFull EXPEDITION/EXPEDITION2 Phase 3 results published: solanezumab failed to improve cognition or functional ability in mild-to-moderate Alzheimer's disease (Doody et al., NEJM 2014;370:311-321).source ↗
  • Aug 29, 2012ReadoutPomaglumetad methionil·SchizophreniamissedIndependent futility analysis of HBBN concluded the second pivotal study was unlikely to succeed; Lilly stopped all Phase 3 development of pomaglumetad methionil the same day.source ↗
  • Aug 24, 2012ReadoutSolanezumab·Alzheimer's diseasemissedEXPEDITION and EXPEDITION2 both miss their co-primary cognitive and functional endpoints in mild-to-moderate Alzheimer's disease; pre-specified pooled secondary analyses suggest slowing of cognitive decline in mild AD only.source ↗
  • Jul 11, 2012ReadoutPomaglumetad methionil·SchizophreniamissedHBBM, the first pivotal study, missed its primary PANSS endpoint in both the overall population and the prospectively defined HTR2A genetic subpopulation; risperidone separated in both.source ↗
  • Mar 1, 2011Phase changePomaglumetad methionil·SchizophreniaPhase 3First Phase 3 study started: H8Y-MC-HBBN (NCT01307800), a placebo-controlled study of 3 doses in acute schizophrenia (registry start date March 2011; month precision — day is an anchor). The second pivotal, HBDE vs aripiprazole (NCT01328093), started April 2011.source ↗
  • May 1, 2009Phase changeSolanezumab·Alzheimer's diseasePhase 3Phase 3 EXPEDITION (NCT00905372) and EXPEDITION2 (NCT00904683) both started May 2009 per ClinicalTrials.gov (400 mg IV q4w vs placebo in mild-to-moderate AD; ~1,000 patients each). Day-of-month not registered — CT.gov gives '2009-05' only, so the anchor is the first of the month.source ↗
  • Aug 23, 2005Phase changePomaglumetad methionil·SchizophreniaPhase 2First patient efficacy study started: H8Y-BD-HBBD (NCT00149292), the randomized, double-blind comparison of LY2140023, olanzapine, and placebo later published as the positive proof-of-concept in Nature Medicine (Patil et al. 2007). Phase 1 start dates are not enumerable from the registry.source ↗

Trials recruiting · 18 recruiting of 304 sponsored

  • Phase 3Donanemab, Placebon=55053 sites · United States, Puerto Rico

    A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).

    Alzheimer DiseaseDementiaPlaque, AmyloidNCT07602582 ↗

  • Phase 3Donanemab, Placebon=14030 sites · China

    Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease

    Alzheimer DiseaseNCT07571161 ↗

  • Phase 3Brenipatide, Placebon=1000186 sites · United States, Japan, China

    A Study of Brenipatide in Adult Participants With Major Depressive Disorder

    Depressive Disorder, MajorNCT07412756 ↗

  • Phase 3LY3537031, Placebon=1100117 sites · United States, China, Japan

    A Study of Brenipatide in Participants With Alcohol Use Disorder

    Alcohol Use DisorderNCT07219953 ↗

  • Phase 3LY3537031, Placebon=1100121 sites · United States, China, Japan

    A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

    Alcohol Use DisorderNCT07219966 ↗

  • Phase 2Donanemab, Placebon=35072 sites · United States, Japan, Taiwan

    A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

    Cognitive DysfunctionLewy Body DiseaseSynucleinopathiesNCT07589595 ↗

  • Phase 2LY4065967, Placebon=15037 sites · United States, Puerto Rico

    A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain

    Diabetic Peripheral Neuropathic PainNCT07285018 ↗

  • Phase 2Brenipatide, Placebo, Buprenorphinen=46557 sites · United States, United Kingdom, Canada

    A Study of Brenipatide in Participants With Opioid Use Disorder

    Opioid Use DisorderNCT07420283 ↗

  • Phase 2Brenipatide, Placebon=450103 sites · United States, Japan, Argentina

    A Study of Brenipatide in Adult Participants With Schizophrenia

    SchizophreniaNCT07410507 ↗

  • Phase 2Brenipatide, Placebon=40087 sites · United States, Japan, India

    A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

    Bipolar DisorderNCT07286175 ↗

  • Phase 2LY3016859 ISA, LY3556050 ISA, LY3526318 ISA, LY3857210 ISA, Placebo Oral, Placebon=1000064 sites · United States, Puerto Rico

    A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

    Osteoarthritis, KneeDiabetic Neuropathic PainChronic Low-back PainNCT05986292 ↗

  • Phase 1LY3439539n=307 sites · Australia, Singapore

    A Study of LY3439539 in Participants With Alzheimer's Disease

    Alzheimer DiseaseNCT07598370 ↗

  • Phase 1LY4256984n=329 sites · Germany, Spain, Canada

    A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

    Amyotrophic Lateral SclerosisNCT07571174 ↗

  • Phase 1LY4256984n=329 sites · Germany, Canada, Spain

    A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)

    Amyotrophic Lateral SclerosisNCT07571200 ↗

  • Phase 1LY4256984, Placebon=3212 sites · Canada, Germany, Spain

    A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

    ALS (Amyotrophic Lateral Sclerosis)NCT07100119 ↗

Showing 15 of 18 recruiting trials.

Competitive landscape

Other companies developing against Eli Lilly and Company's targets or indications.