Current Landscape of Sarcopenia Drug Development and the Role of SPPB

Sarcopenia is a progressive loss of muscle mass and function associated with aging and is strongly linked to increased risk of falls, fractures, metabolic disorders, depression, and mortality. As global aging accelerates, sarcopenia is increasingly recognized not just as a natural consequence of aging but as a distinct clinical condition requiring targeted intervention.

Although no sarcopenia drug has yet been approved by the U.S. FDA, global pharmaceutical companies are actively developing a range of investigational therapies targeting different biological mechanisms. Notable examples include Sarconeos (Biophytis), Bimagrumab (initially by Novartis), Trevogrumab (Regeneron), and Anamorelin (Helsinn). However, some agents that succeeded in increasing muscle mass failed to demonstrate significant improvement in functional outcomes such as gait speed or SPPB (Short Physical Performance Battery) scores, leading to early termination of trials.

In response to muscle loss observed during rapid weight reduction from GLP-1 receptor agonists, companies are now exploring combination strategies. Regeneron is preparing a phase 2 trial that combines semaglutide (Wegovy/Ozempic) with its anti-myostatin antibody Trevogrumab and its anti-Activin A antibody Garetosmab, which is under development for fibrodysplasia ossificans progressiva. Similarly, Eli Lilly is planning a combination study using tirzepatide (Zepbound/Mounjaro) with Bimagrumab, acquired through its purchase of Versanis. These approaches aim to preserve lean body mass and maintain functional muscle strength while sustaining weight loss effects.

SPPB has emerged as a core functional assessment tool in these clinical trials, providing standardized and objective evaluation of lower extremity function. It is now widely used as the primary outcome measure in global sarcopenia trials, and is officially recommended by the Global Leadership Initiative on Sarcopenia (GLIS).

This trend is also reflected in Korea. In May 2024, the Ministry of Food and Drug Safety (MFDS) published an updated version of its “Human Study Design Guidelines for Health Functional Food Developers.” For the first time, the guideline explicitly states that individuals with SPPB scores above 9 are eligible for inclusion in clinical studies targeting muscle function improvement. This marks a significant refinement from the previous year’s criteria, which were based only on handgrip strength. The update aligns closely with national sarcopenia clinical guidelines that emphasize the importance of “functional sarcopenia.”

In this context, SPPB is not only the primary endpoint in sarcopenia drug trials worldwide but is also gaining traction as a screening and eligibility criterion for functional food development in Korea.

AndanteFit, a fully automated SPPB assessment device, has been adopted in clinical trials by two Korean pharmaceutical companies across six research sites. It was selected for its ability to deliver accurate, objective results while ensuring inter-tester reliability. We welcome inquiries from pharmaceutical and health supplement companies — both domestic and international — who are engaged in sarcopenia drug or functional ingredient development.