Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2220 |
| INN | Solanezumab |
| Status | Terminated |
| Drug code(s) | LY-2062430, hM266.2 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Amyloid beta (monomers) |
| Indications of clinical studies | Alzheimer's Disease |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | June 15, 2004 |
| Start of Phase 2 | May 15, 2007 |
| Start of Phase 3 | May 15, 2009 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Eli Lilly and Company |
| Licensee/Partner | None |
| Comments about company or candidate | March 8, 2023 I Eli Lilly and Company announced that solanezumab did not slow the progression of cognitive decline due to Alzheimer's disease (AD) pathology when initiated in individuals with amyloid plaque but no clinical symptoms of the disease, known as the preclinical stage of AD1. Solanezumab only targets soluble amyloid beta. The treatment did not clear plaque or halt accumulation of amyloid in participants treated with the drug in the Anti-Amyloid Treatment in Asymptomatic Alzheimer's disease (A4) Study. "Results of the A4 Study clearly showed that the primary and secondary endpoints were not met. Therefore, the A4 Study concludes our clinical development of solanezumab and indicates that targeting soluble amyloid beta through this mechanism is not effective in this population, Listed as Phase 3 asset in Lilly pipeline dated Q4 2022. NCT02008357 Phase 3 Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss is active not recruiting as of July 2021. NCT01760005 Phase 2/3 study started inDec 2012 recruiting as of last update in Nov 2022; A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease. Listed as in ongoing prevention study as of March 2021: https://investor.lilly.com/static-files/8238c02c-6a84-4c8d-be02-bd12218e9d6b Feb 2020: Eli Lilly and Company announced top-line results from the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU; NCT01760005) Study of solanezumab for the treatment of Alzheimer's disease (AD). The analysis performed by Washington University School of Medicine in the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study showed that solanezumab did not meet the primary endpoint. Feb 2017: Lilly terminated the double-blind, placebo-controlled, international Phase III EXPEDITION-PRO trial of IV solanezumab every 4 weeks for up to 2 years to treat prodromal AD after reviewing data from the double-blind, international Phase III EXPEDITION3 trial in patients with mild dementia due to AD. The company said it did not find evidence suggesting solanezumab would confer a meaningful benefit. Lilly will not pursue regulatory submissions for solanezumab for the treatment of mild dementia due to Alzheimer's disease. NCT01900665 Phase 3 studies in patients with mild AD recruiting as of Nov 2013. Primary endpoints, both cognitive and functional, were not met in either of the two Phase 3 trials of Alzheimer’s disease; (EXPEDITION1 and EXPEDITION2). However,the results showed significant slowing of cognitive decline in patients with mild-to-moderate Alzheimer's disease |
| Full address of company | Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us |
Target is Amyloid beta monomers https://media.nature.com/full/nature-cms/uploads/ckeditor/attachments/8368/Lilly.pdf
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |