Eli Lilly and Company Limited

Eli Lilly and Company is a multinational pharmaceutical company, and the most valuable company in its sector globally. with a nearly $800 billion market capitalization — nearly as large as its two closest competitors combined.

Lilly has a large and diverse portfolio, but does not see itself as a longevity therapeutics company. However, it has FDA-approved damage-repair longevity therapeutics in its portfolio.

Additionally, Lilly has several partnerships with BioAge Labs. It also took part in an October 2025 funding round with the reprogramming company NewLimit. This funding aims to prepare for NewLimit’s first clinical study in a few years.

Donanemab

Donanemab (brand name Kisunla) is a monoclonal antibody that removes N-truncated pyroglutamate beta-amyloid. It is one of the first FDA-approved drugs that slows the progress of Alzheimer’s disease (AD) instead of just easing symptoms.

In addition to directly clearing beta-amyloid, Donanemab treatment reduces downstream damage and abnormalities. These include a reduction in normal cerebrospinal fluid levels of pTau217, a damaged type of tau.

pTau217 is a biomarker that strongly correlates with disease risk and progression. It helps to predict the future risk of Alzheimer’s disease in people who are cognitively normal for their age. It also helps to understand the disease’s course in those who are affected.

Additionally, Donanemab lowers the number of reactive astrocytes in the brain.

Despite these positives, the effect of Donanemab on Alzheimer’s disease is modest. However, studies show it works better when started early in the disease.

Donanemab clinical trial results

Lilly shared results from the Phase III TRAILBLAZER-ALZ 2 trial at the Alzheimer’s Association International Conference (AAIC).

In this study, participants originally given Donanemab continued on the drug whenever their beta-amyloid level exceeded a predefined threshold. Participants who had originally received a placebo were offered the option to switch to the Donanemab protocol.

All the participants who received Donanemab saw benefits. Those who used the therapeutic antibody throughout had a lower risk of progressing to the next stage. This was compared to the original placebo group.

The benefits of Donanemab increased over the three years of the trial and extension study. This was compared to matched natural history controls.

When people reached their set minimum level of beta-amyloid plaque and switched to placebo, amyloid returned very slowly. This matches earlier data from untreated subjects and models. No new safety issues were found.

FDA approved label update

In July 2025, Lilly announced that the FDA approved a new label for Donanemab. This update includes a changed dosing schedule. The change was based on the results of the TRAILBLAZER-ALZ 6 trial.

This trial showed that the new schedule reduced the occurrence of amyloid-related imaging abnormalities with edema (ARIA-E). This is the most concerning side effect of Donanemab. The rate dropped from 25% in people on the original dosing plan to 16% in those on the modified titration.

Both groups had similar clearance of amyloid plaque and reductions in pTau217.

Australian approval for treatment

In May 2025, Australia’s Therapeutic Goods Administration (TGA) approved Donanemab for the treatment of “mild” cognitive impairment (MCI). It was also approved for mild impairment from Alzheimer’s dementia. This applies to people who do not have the ApoE ε4 gene and those who have one copy of it.

The European Medicine Agency approves Donanemab

In July 2025, the European Medicine Agency (EMA) changed its earlier opinion. The advisory committee recommended approving Donanemab for ApoE4 non-carriers and those with one copy.

The NHS does not approve due to cost

Donanemab (and Lecanemab) are not available on the UK’s National Health Service (NHS). This is because of a cost-benefit analysis by the National Institute for Health and Care Excellence (NICE).

Unfortunately if the cost is considered to be too high compared to the results, it will not be approved. Given the NHS is a free at point of service healthcare system, such things must be considered carefully.

The future for the TRAILBLAZER-ALZ 3 trial

The ongoing TRAILBLAZER-ALZ 3 trial will test if Donanemab can help older volunteers. These participants are aged 65 to 80 and are cognitively healthy, but have abnormal tau markers in their blood.

The goal is to see if Donanemab can stop them from developing dementia.

Bimagrumab

Bimagrumab (LY3985863) is a monoclonal antibody. It stops ligands from binding to the activin/myostatin type II receptors, ActRIIA and ActRIIB, on muscle cell membranes.

Myostatin and other activin ligands stop muscle precursor cells from becoming mature muscle cells. They also cause existing muscle fibers to atrophy.

Conversely, follistatin blocks this interaction, thereby increasing muscle mass. Bimagrumab stops myostatin and other ActRII signaling molecules from connecting to ActRIIs. This action removes a limit on muscle growth.

In 2023, Lilly acquired the biotech startup Versanis and its lead asset Bimagrumab. Their goal was to improve body composition in combination with its incretin agonist drugs in the treatment of obesity.

However, Bimagrumab has a prior history of study for more classically age-related things. Conditions such as to improve outcomes after a hip fracture, sporadic inclusion body myositis (sIBM), and sarcopenia.

Bimagrumab in clinical trials

In June 2025, Lilly announced the results of the Phase IIb BELIEVE trial. This was a randomized, double-blind study. It compared the effects of Bimagrumab alone and with semaglutide in overweight or obese adults.

Bimagrumab alone led to a 10.8% loss of body weight. This came entirely from adipose tissue, while subjects gained 2.5% in total lean mass.

In combination treatment patients, 92.8% of the total weight loss came from fat mass, versus 71.8% in semaglutide alone. Combination therapy led to increased loss of total body weight, total body fat, visceral fat, and inflammation.

Another trial (NCT06643728) is currently underway with a similar design using Lilly’s Tirzepatide.

Juvena Therapeutics Collaboration

In June 2025, Eli Lilly entered into a licensing and multi-target research collaboration with Juvena Therapeutics. The goal is to find, develop, and sell drug candidates that enhance muscle health and body composition. This will be done using Juvena’s AI platform to screen proteins from stem cells.